Conditions: Ovarian Cancer Ovarian Neoplasms Ovarian Carcinoma Fallopian Tube Cancer Epithelial Ovarian Cancer Primary Peritoneal Carcinoma
Keywords: Epithelial Ovarian Cancer (EOC) Ovarian Cancer Platinum-Resistant Ovarian Cancer Cluster of Differentiation 47 (CD47) maplirpacept (PF-07901801) TTI-622 Doxorubicin Immune-oncology chemotherapy anti-SIRPα therapy
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 10
Healthy volunteers: no

Brief summary:
Pegylated liposomal doxorubicin (PLD), a type of chemotherapy, is a standard treatment option for patients with platinum-resistant ovarian cancer. However, despite being consider a standard treatment option, the clinical benefit of chemotherapy alone for these patients is small. Historically, response rates for PLD monotherapy have only ranged from 12 to 35% with a high likelihood of recurrence within months after treatment initiation. Although bevacizumab (BEV), an anti-new-vascular growth monoclonal antibody has been approved by FDA to combine with standard chemotherapy (e.g., PLD) for platinum-resistant recurrent ovarian cancer, there are still many restrictions or contraindications preventing certain women from receiving bevacizumab's combination treatment. The goal of this study is to improve upon the activity of PLD in a safe manner to provide a more effective therapeutic option for this group of patients.

The purpose of this study is to assess maplirpacept (PF-07901801) administered in combination with PLD in patients with platinum-resistant ovarian cancer and for whom PLD is a reasonable treatment option. The first portion of the study will evaluate the safety of increasing dose levels of maplirpacept (PF-07901801) in combination with PLD at 40 mg/m2 in patients with platinum-resistant EOC (epithelial ovarian cancer). This is a group of cancer, including ovarian, peritoneal, and fallopian tube malignancy. The aim of the first portion of the study is to establish a combination regimen for further assessment in a dose expansion cohort.

The study will consist of a 28-day screening period to ensure participants are qualified for the study treatment plan. During the treatment period, patients will receive maplirpacept (PF-07901801) in combination with PLD in 28-day cycles until their disease progresses or unacceptable toxicity develops. There will be a long-term follow-up period in this study to assess overall survival (length of time since start of treatment patients are alive).

Detailed description:
Pegylated liposomal doxorubicin (PLD) is a standard treatment option for patients with platinum-resistant ovarian cancer who are not candidates for chemotherapy in combination with bevacizumab. However, despite being consider a standard treatment option, the clinical benefit of chemotherapy for this patient population is small. The goal of this clinical trial is to improve upon the activity of PLD in a safe manner to provide a more effective therapeutic option for this group of patients.

C4971002 (TTI-622-02) is a multi-center, open-label study designed to evaluate maplirpacept (PF-07901801) administered in combination with PLD in patients with platinum-resistant ovarian cancer and for whom PLD is a reasonable treatment option. The first portion of the study will evaluate the safety of increasing dose levels of maplirpacept (PF-07901801) in combination with PLD at 40 mg/m2 in patients with platinum-resistant EOC, including ovarian, peritoneal and fallopian tube malignancy, and establish a combination regimen for further evaluation in a dose expansion cohort. The study will consist of a 28-day screening period, a treatment period in which patients will receive maplirpacept (PF-07901801) in combination with PLD in 28-day cycles until documentation of objective disease progression or development of unacceptable toxicity, and a long-term follow-up period to assess overall survival.

Arms:
arm 1: In the Phase 1 (dose escalation):

Cycle 1 for dose levels 1 and 2, maplirpacept (PF-07901801) will be administered on Day 1, Day 8, Day 15 and Day 22 in combination with PLD on Day 1 of 28-day cycle. Beginning with Cycle 2 at dose levels 1 and 2, maplirpacept (PF-07901801) will be administered on Day 1 and Day 15 in combination with PLD on Day 1 of 28-day cycles. For Phase 1, dose level 3, maplirpacept (PF-07901801) will be administered on Day 1 and Day 15 in combination with PLD on Day 1 of 28-day cycles. Dose level 3 will be biweekly regimen from the start. arm 2: In the Phase 2 (dose expansion):

maplirpacept (PF-07901801) will be administered with selected dose from the escalation phase by intravenous infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 in subsequent cycles in combination with Pegylated Liposomal Doxorubicin 40 mg/m2 by intravenous infusion on Day 1 of each 28-day cycle.

Interventions: intervention 1: maplirpacept (PF-07901801) intervention 2: Pegylated Liposomal Doxorubicin (PLD)
Intervention descriptions: intervention 1: PF-07901801 Escalation (3-dose-level 12, 24, and 48 mg/kg), in combination with Pegylated Liposomal Doxorubicin (40mg/m2) will be administered by intravenous infusion. intervention 2: RP2D of maplirpacept (PF-07901801) biweekly of maplirpacept (PF-07901801) from Phase 1 escalation in combination with pegylated liposomal doxorubicin 40mg/m2

Protocol document:
Prot_000.pdf: 
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Investigational 
Product
TTI-622 (SIRPα-IgG4 Fc)/PF-07901801
Protocol 
Number
TTI-622-02/C4971002
IND Number
157225
Phase of Clinical 
Development
I/II
Protocol Title
A Phase I/II Study of TTI-622 in Combination with Pegylated 
Liposomal Doxorubicin in Patients with Platinum-Resistant Ovarian 
Cancer
Version and 
Date
Version 2.0, 07 December 2022
CONFIDENTIALITY STATEMENT
This document and accompanying materials contain confidential information belonging to Pfizer. Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified.
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1 PROTOCOL APPROVAL
Protocol Number
C4971002 (TTI-622-02)
Version and Date
Version 2.0, 07 December 2022
Protocol Title
A Phase I/II Study of TTI-622 in Combination with Pegylated 
Liposomal Doxorubicin in Patients with Platinum-Resistant Ovarian 
Cancer
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2 SYNOPSIS
Protocol Number
C4971002 (TTI-622-02)
Version and Date
2.0, 07 December 2022
Phase of Clinical 
Development
Phase I/II
Protocol Title
A Phase I/II Study of TTI-622 in Combination with Pegylated 
Liposomal Doxorubicin in Patients with Platinum-Resistant 
Ovarian Cancer
Investigational 
Product
TTI-622 (SIRPα-IgG4 Fc)/PF-07901801
IND Number
157225
Study Population
Participants aged 18 years or older with platinum-resistant 
recurrent ovarian cancer who have not received more than four 
prior lines of treatment for platinum-resistant disease
General 
Investigative Plan
This study will investigate a new therapeutic regimen for 
participants with platinum-resistant recurrent epithelial ovarian 
cancer (EOC), defined as disease progression ≤6 months after the 
most recent platinum-based treatment regimen or patients who 
were no longer able to receive or declined treatment with 
platinum-based chemotherapy, and who have not received more 
than four regimens for platinum-resistant disease. The safety and 
MTD, if reached, and RP2D of PF-07901801 (TTI-622) 
administered by intravenous infusion on Day 1 and Day 15 of 
28-day cycles in combination with fixed-dose pegylated liposomal 
doxorubicin (PLD) (40 mg/m2 on Day 1 of 28-day cycles) will be 
established in the Phase 1 dose escalation portion of the study and 
the clinical activity of the MTD and RP2D will then be evaluated 
in an expansion cohort in the same participant population. 
Investigative Sites
Up to 10 centers in the US 
Planned Number of 
Subjects
Up to approximately 50 participants, including up to 18 DLT-
evaluable in the Phase 1 dose escalation portion of the study and 
up to  30 treated in the Phase 2 expansion portion. 
Background and 
Rationale
Ovarian cancer is the second most common gynecologic 
malignancy in developed countries and the third most common 
gynecologic malignancy in developing countries. The majority 
(95%) of ovarian malignancies are epithelial in nature.1,2,3
High-grade serous carcinoma, the most common histologic 
subtype, generally includes fallopian tube and peritoneal serous 
carcinoma, based upon similarities in histology and clinical 
behavior. Epithelial cancers of ovarian, fallopian tube, and 
peritoneal origin exhibit similar clinical characteristics, behavior, 
and in many cases, share basic biology. As such, these are often 
considered collectively and defined as epithelial ovarian cancer 
(EOC) in clinical trials and clinical practice.
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Despite initial therapy (usually consisting of surgical 
cytoreduction and platinum-taxane combination therapy), the 
majority of patients with advanced-stage ovarian cancer will 
relapse and require additional treatment. Patients with
platinum-sensitive recurrent EOC, defined as recurrence at least 
6 months after completion of prior-platinum-based treatment, are 
more likely to respond to retreatment with a chemotherapy 
regimen that contains a platinum. In addition, several trials 
suggest that patients with platinum-sensitive disease achieve 
better response rates and PFS using maintenance treatment. This 
may consist of bevacizumab or the PARP inhibitors olaparib, 
niraparib and rucaparib (all of which have been approved by 
FDA, although only bevacizumab has shown an overall survival 
benefit).
Patients with platinum-resistant recurrent EOC, defined as disease 
progression ≤6 months after the most recent platinum-based 
treatment regimen (versus platinum-refractory disease, defined as 
progression while on therapy or within three months of 
completing their primary first-line platinum-based treatment), 
present with disease that is generally not curable and treatments 
should aim to maximize quality of life while attempting to control 
disease. Thus, this setting is an urgent unmet medical need and 
current treatment options typically consist of single-agent 
chemotherapy, including weekly paclitaxel or PLD. In the 
AURELIA study, patients who received chemotherapy, including 
PLD at 40 mg/m2, experienced a median PFS of less than 4 
months and approximately 8% ORR.4,5 Some patients are 
candidates for combination therapy with bevacizumab, which 
consistently results in better outcomes compared to chemotherapy 
alone, but this regimen is limited to those who did not receive 
bevacizumab in the platinum-sensitive setting and who have not 
had recent (prior 6 months) bowel obstruction and do not have 
malignant bowel involvement. The addition of bevacizumab to 
PLD chemotherapy in the AURELIA study raised the ORR to 
only 14% and the mPFS to 5 months.4,5 highlighting the need for 
more effective treatments – treatments that offer disease control
without increased toxicity – for this patient population.
PF-07901801 is a recombinant soluble fusion protein designed to 
block the cell-surface protein CD47, which is found on the surface 
of many normal cell types and at high levels on many malignant 
tumor cells. 
 
 
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Many solid tumors, including ovary, brain, breast, colon, gastric, 
kidney, soft tissue sarcomas, liver, lung, melanoma, pancreatic, 
and prostate tumors have also been found to express high levels of 
CD47.6-10 In many of these cases, high expression of 
 
 
CD47 protein is highly 
expressed in ovarian cancer and is correlated with poor clinical 
characteristics and prognosis.11,12 Decreasing CD47 levels in 
ovarian cancer cell lines resulted in promotion of macrophage 
phagocytosis and tumor growth in vivo.12
 
 
 
3 Trillium’s CD47-targeted molecules 
significantly inhibit the growth of ovarian cancer in xenograft 
models.
It is hypothesized that blockade of CD47-mediated immune 
evasion and concomitant activation of phagocytosis with 
PF-07901801 will be clinically beneficial in participants with 
ovarian cancer in which CD47 is generally highly expressed. The 
favorable safety profile of PF-07901801 observed in an ongoing 
clinical trial (NCT03530683) suggests that combining 
PF-07901801 with other therapies might offer an effective 
treatment option for participants without the addition of 
prohibitive toxicity. Thus, the primary goal of this clinical trial is 
to evaluate the safety and activity of PF-07901801 administered in 
combination with the standard of care PLD regimen in 
participants with platinum-resistant EOC.
Study Design
This is a multi-center, open-label study designed to evaluate 
PF-07901801 administered in combination with PLD in 
participants with platinum-resistant recurrent EOC, including 
ovarian, peritoneal and fallopian tube malignancy. The study will 
consist of a 28-day screening period, a treatment period in which 
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participants will receive PF-07901801 in combination with PLD 
in 28-day cycles until documentation of objective disease 
progression or development of unacceptable toxicity, and a 
long-term follow-up period to assess overall survival.
Key inclusion criteria are ECOG performance status 0-1, 
platinum-resistant recurrent EOC, defined as disease progression 
≤6 months after the most recent platinum-based-treatment 
regimen(or no longer able to receive platinum-based 
chemotherapy), no more than four prior regimens for 
platinum-resistant disease, measurable disease by RECIST v1.1, 
absence of bowel obstruction history, and adequate cardiac and 
end organ function. Participants with exposure to PLD, while 
platinum-resistant or in the treatment regimen immediately prior 
to enrollment in this study, will not be eligible for treatment under 
this protocol; however, earlier exposure to PLD, including while 
platinum-sensitive, or for an indication other than recurrent 
platinum-resistant EOC, eg, breast cancer, will be allowed for 
participants in the Phase 1 dose escalation portion of the study. In 
the Phase 2, dose expansion portion of the study, depending on 
clinical benefit during Phase 1, earlier exposure to PLD, including 
while platinum-sensitive, may be allowed if agreed upon by the 
investigators and Pfizer. Prior treatment with doxorubicin or other 
anthracyclines’ equivalents at total cumulative doses must not be 
greater than 320 mg/m2 for doxorubicin, and calculated using 
doxorubicin equivalent doses: 1 mg doxorubicin= 1 mg pegylated 
liposomal doxorubicin (PLD)= 1.8 mg epirubicin= 0.3 mg 
mitoxantrone= 0.25 mg idarubicin.
In the Phase 1 dose escalation portion of the study, the primary 
objective is assessment DLTs, safety and tolerability of escalating 
dose levels of PF-07901801 in combination with PLD at the 
standard dose of 40 mg/m2. Up to approximately 18 participants 
are planned to be enrolled in this portion of the study to evaluate 
three dose levels of PF-07901801 12 mg/kg (Dose Level 1), 24 
mg/kg (Dose Level 2) and 48 mg/kg (Dose Level 3). In Cycle 1 
for dose levels 1 and 2, PF-07901801 will be administered on Day 
1, Day 8, Day 15 and Day 22 in combination with PLD on Day 1 
of 28-day cycle. Beginning with Cycle 2 at dose levels 1 and 2, 
PF-07901801 will be administered on Day 1 and Day 15 in 
combination with PLD on Day 1 of 28-day cycles. The enhanced 
dosing in Cycle 1 represents a loading cycle and is intended to 
allow PF-07901801 levels to more quickly reach steady state. For 
dose level 3, PF-07901801 will be administered on Day 1 and 
Day 15 in combination with PLD on Day 1 of 28-day cycles.
Loading doses (Day 8 and Day 22) may be considered for Cycle 1 
at the 48 mg/kg dose level if found to be safe and offer clinical 
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benefit for participants. If Cycle 1 loading doses are implemented, 
all dosing and lab draw schedules for the 48 mg/kg dose will 
follow the schedules for dose levels 12 mg/kg and 24 mg/kg.
One dose level combination will be selected for further evaluation 
in the Phase 2 expansion portion of the study. The primary 
objective of the Phase 2 expansion portion of the study is 
investigation of clinical activity of the PLD and PF-07901801 
combination; clinical activity will be assessed using the overall 
response by RECIST v1.1 as the primary efficacy endpoint. 
Secondary objectives include further evaluation of the safety of 
the combination and assessment of other indicators of disease 
control, including progression-free survival, overall survival, 
duration of response, and disease control (CR, PR, or SD ≥12 
weeks) as defined by RECIST v1.1 criteria. 
Exploratory objectives include, evaluation of CA-125 levels, 
characterization of PF-07901801 and PLD pharmacokinetics 
when co-administered, evaluation of development of antibodies 
directed against PF-07901801; exploration of possible 
relationships between PF-07901801 exposure and clinical 
outcome, safety and pharmacodynamics observations, and to 
understand the relationship between the therapeutic 
intervention(s) being studied and the biology of the participant’s 
disease. Exploratory endpoints include but are not limited to PK 
and immunogenicity of PF-07901801, PK of PLD, CA-125 levels, 
measurements of biomarkers/pharmacodynamics, which may 
consist of DNA, RNA, protein or defined cell types, resulting 
from analyses of peripheral blood and/or tumor tissue 
biospecimen obtained at baseline, on treatment and/or at end of 
study, as well as the single and multiple dose pharmacokinetics of 
PF-07901801.
PLD will be administered at 40 mg/m2 on Day 1 of each 28-day 
cycle. Medications to treat infusion-related reactions and CPR 
equipment must be available for immediate use prior to initiation 
of PLD infusion.
The dose-limiting toxicity (DLT) evaluation period will consist of 
the 28-day Cycle 1 or until participants experience a DLT in 
Cycle 1. Participants will be considered DLT evaluable if they 
received PLD on Day 1 and at least two infusions of PF-07901801 
(TTI-622) in the 28-day Cycle 1. A participant who withdraws 
from the study during Cycle 1 in the absence DLT evaluable (ie, 
not receiving PLD and at least two doses of PF-07901801) will be 
replaced. If a dose-limiting toxicity as defined in Section 5.4 is 
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encountered in one participant in the initial three participants in a 
dose cohort, three additional participants will be enrolled in 
accordance with the standard 3+3 study design. The maximum 
tolerated dose (MTD) for this study will be defined as the highest 
PF-07901801 dose level at which <33% of participants within a 
dose cohort experience dose-limiting toxicity when administered 
in combination with PLD at 40 mg/m2. While three pre-defined 
PF-07901801 dose levels are anticipated, intermediate dose levels 
may be studied to more closely characterize the safety profile of 
PF-07901801 in combination with PLD.
After three to six participants in a dose cohort, complete the 28-
day dose-limiting toxicity assessment period, the incidence of 
dose-limiting toxicity, treatment-related safety observations and 
other available data, such as pharmacokinetic data, will be 
reviewed by the medical monitor, sponsor and investigators. If no 
participant in a three-participant cohort or no more than one 
participant in a six-participant dose cohort experiences treatment-
related dose-limiting toxicity, the dose level will be deemed safe 
and dose escalation may proceed unless there are other 
unsuspected but concerning safety observations that suggest either 
an expansion of the current dose level or implementation of an 
intermediate dose level.
Objective disease assessments will be performed every 8 (±1) 
weeks through week 48, or until participant has been on study for 
one year, and every 12 (±2) weeks thereafter. Participants who 
withdraw from the study without objective evidence of disease 
progression will be followed until documentation of disease 
progression or initiation of another treatment. All participants will 
be followed in the Long-Term Follow-Up period for survival.
Assessment of 
Dose-Limiting 
Toxicity
Dose escalation and cohort expansion decisions will be based on 
the incidence of dose-limiting toxicity assessed in the 28-day 
Cycle 1. A participant will be evaluable for dose-limiting toxicity 
if the participant experiences a DLT during Cycle 1 or did not 
experience a DLT and received PLD on Day 1 andat least two 
infusions of PF-07901801  in the 28-day Cycle 1 and completed 
28-day cycle safety evaluation period. A participant who 
withdraws from the study during Cycle 1 in the absence of DLT 
evaluable (ie, not receiving PLD and at least two doses of PF-
07901801) will be replaced.
Dose-limiting toxicity is defined as any of the following 
treatment-emergent adverse events that occurs during Cycle 1 and 
are judged by the Investigator as related to PF-07901801 or the 
combination of PF-07901801 and PLD. Adverse events that are in 
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the opinion of the Investigator attributable exclusively to 
intravenous infusion of PLD or any PLD prophylaxis medication 
will not be considered a dose-limiting toxicity.
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Duration of 
Treatment and 
Subject 
Participation
Participants may continue treatment until progression or 
development of unacceptable toxicity. Participants who receive at 
least four cycles of PLD in combination with PF-07901801 and 
experience adverse events associated with PLD that require 
discontinuation of PLD treatment may continue treatment with 
PF-07901801 monotherapy.
With a 28-day screening period and an estimated 12 months of 
treatment, it is anticipated that participants may participate in the 
active portion of the study for up to approximately one year.
Inclusion Criteria
General
1. Written informed consent obtained prior to performing any 
study-specific procedure, including screening procedures
2. Females ≥18 years of age
3. ECOG Performance Status 0 or 1
Disease Characteristics
4.
Histologically-confirmed epithelial ovarian cancer (EOC), 
fallopian tube carcinoma (FTC) or primary peritoneal 
carcinomas (PPC).
Eligible histological subtypes are:
•
Adenocarcinoma NOS
•
Clear cell adenocarcinoma
•
Endometrioid adenocarcinoma
•
Malignant Brenner’s tumor
•
Mixed epithelial carcinoma
•
Mucinous adenocarcinoma
•
Serous adenocarcinoma
•
Transitional cell carcinoma
•
Undifferentiated carcinoma
5.
Platinum-resistant recurrent disease, defined as disease 
progression ≤6 months after the most recent of platinum-
based treatment regimen (date calculated from the last 
administered dose of platinum) or the participant is no longer 
able to receive or declined treatment with platinum-based 
chemotherapy
o
Includes standard of care therapies, including 
platinum-based therapies, PARP inhibitors (poly ADP 
ribose polymerase) or bevacizumab in the platinum-
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sensitive setting or intolerability to such therapies or 
participant refusal
6.
Measurable disease per RECIST v1.1; target lesions must not 
be chosen from a previously-irradiated field unless there has 
been radiographically and/or pathologically documented 
tumor progression in that lesion prior to enrollment
Organ Function
Adequate organ and hematologic function as defined below:
7.
Serum AST and ALT ≤ 3 x upper limit of normal (ULN); 
≤5 x ULN in the presence of liver metastasis
8.
Serum bilirubin (total) ≤ 1.5 x ULN (≤ 2 x ULN if 
hyperbilirubinemia is due to Gilbert’s syndrome)
9.
Serum creatinine ≤1.5 x ULN OR creatinine 
clearance/estimated glomerular filtration rate (eGFR) 
≥40 mL/min/1.73 m2 if serum creatinine is >1.5 x ULN
10.
Hemoglobin ≥9 g/dL; packed red blood cell transfusions are 
not allowed in the two weeks preceding screening evaluation
11.
ANC ≥1.5 × 109/L
12.
Platelet count ≥ 100 × 109/L
13.
Left ventricular ejection fraction (LVEF) determined by 
echocardiogram or multigated acquisition scan >50% at 
screening
Previous Therapy
14.
Unlimited lines of therapies in the platinum-sensitive setting 
are allowed. Once a participant becomes platinum-resistant 
no more than 4 prior treatment regimens for platinum-
resistant disease are allowed. 
•
If bevacizumab was not used as a treatment option during 
the platinum-sensitive setting, then bevacizumab in 
combination with paclitaxel must be considered as the 
first-line platinum-resistant treatment option except in the 
case of intolerability to such therapies or participant 
refusal.
15.
Participants with exposure to PLD while platinum-
resistant or in the treatment regimen immediately prior to 
enrollment in this study, will not be eligible for treatment 
under this protocol; however, earlier exposure to PLD, 
including while platinum-sensitive, or for an indication 
other than recurrent platinum-resistant EOC, eg breast 
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cancer, will be allowed for participants in the Phase 1 dose 
escalation portion of the study. In the Phase 2, dose 
expansion portion of the study, depending on clinical 
benefit during Phase 1, earlier exposure to PLD, including 
while platinum-sensitive, may be allowed if agreed upon 
by the investigators and Pfizer. Prior treatment with 
doxorubicin or other anthracyclines’ equivalents at total 
cumulative doses must not be greater than 320 mg/m2 for 
doxorubicin, and calculated using doxorubicin equivalent 
doses: 1 mg doxorubicin= 1 mg pegylated liposomal 
doxorubicin (PLD)= 1.8 mg epirubicin= 0.3 mg 
mitoxantrone= 0.25 mg idarubicin
16.
All adverse events from prior treatment must be NCI 
CTCAE v5 Grade ≤1, except alopecia and stable 
neuropathy, which must have resolved to Grade ≤ 2 or 
baseline
Contraception
17.
Female participants of childbearing potential (CBP) who 
participate in the study should be counseled on the need to 
practice adequate birth control and on the importance of 
avoiding pregnancy during study participation. Please 
refer to Section 6.6 and Appendix C for detailed 
reproductive criteria.
18.
Female participants of childbearing potential must have a 
serum pregnancy test at screening. Following screening, 
pregnancy tests may be urine or serum tests, and must 
have a sensitivity of at least 25 mIU/mL. A negative 
pregnancy test result at screening and at baseline is 
required before the first study drug administration. 
Exclusion Criteria
1. Platinum-refractory disease, defined as progression on or 
within 3 months of completing primary first-line 
platinum-based treatment
2. Malignant mixed Mullerian tumors
3. Ovarian tumors with low malignant potential (i.e., borderline 
tumors), low grade serous ovarian cancer 
Cardiovascular System
4. History of acute coronary syndromes, including myocardial 
infarction, coronary artery bypass graft, unstable angina, 
coronary angioplasty or stenting within 24 weeks prior to first 
administration of study drug
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5. History of or current Class II, III or IV heart failure as defined 
by the New York Heart Association (NYHA) functional 
classification system or symptomatic or poorly controlled 
cardiac arrhythmia 
6. Uncontrolled or poorly-controlled hypertension (defined as 
systolic blood pressure >160 mm Hg and/or diastolic 
>100 mg Hg) for more than four weeks despite optimal 
medical management
7. Peripheral vascular disease > Grade 3 (i.e., symptomatic and 
interfering with activities of daily living requiring repair or 
revision)
General and Infectious Disease
8. Investigator site staff directly involved in the conduct of the 
study and their family members, site staff otherwise 
supervised by the investigator, and sponsor and sponsor 
delegate employees directly involved in the conduct of the 
study and their family members
9. Any comorbidity or concomitant medication or other medical 
or psychiatric condition including recent (within the past year) 
or active suicidal ideation/behavior or laboratory abnormality 
that may increase the risk of study participation that in the
opinion of the investigator and/or sponsor medical monitor 
renders the participant unsuitable for participation in the trial 
or unlikely to fully comply with study procedures, restrictions 
and/or requirements that are considered relevant for evaluation 
of the efficacy or safety of the trial drug
10. Uncontrolled intercurrent illness, including active or chronic 
uncontrolled bacterial, fungal, or viral infection, including 
(but not limited to) HBV, HCV, and known HIV or AIDS 
related illness requiring systemic therapy or oral or systemic 
antibiotics within 14 days prior to study start. Participants 
with HIV with an undetectable viral load and a CD4 count 
≥400 μL are eligible
11. History of non-viral hepatitis or cirrhosis, alcohol abuse or 
active tuberculosis
12. Administration of live attenuated vaccines within 28 days 
prior to start of treatment or anticipated need for vaccination 
with live attenuated vaccine during the study
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13. COVID-19/SARS-CoV-2: While SARS-CoV-2 testing is not 
mandated for entry into this study, testing should follow local 
clinical practice standards. If a participant has a positive test 
result for SARS-CoV-2 infection, is known to have 
asymptomatic infection or is suspected of having SARSCoV2, 
the participant is excluded until a negative antigen test and 
resolution of symptoms if applicable
14. Major surgery within 28 days of scheduled Cycle 1 Day 1 
dosing or minor surgery within seven days prior to initiation 
of study treatment or elective or planned major surgery to be 
performed during the course of the clinical trial
CNS Disease Considerations
15. History or evidence of known CNS metastases or 
carcinomatous meningitis; participants with previously treated 
brain metastases may participate provided they are stable 
(without evidence of progression by imaging for at least four 
weeks prior to the first dose of trial treatment and any 
neurologic symptoms have returned to baseline), have no 
evidence of new or enlarging brain metastases, and are not 
using steroids for at least seven days prior to study treatment; 
this exception does not include carcinomatous meningitis 
which is excluded regardless of clinical stability
Coagulation Considerations
16. Significant bleeding disorders, vasculitis or a significant 
bleeding episode within three months prior to study entry. 
Ongoing prophylactic anticoagulation therapy at a stable dose for 
prevention of VTE (Venous Thromboembolism) are allowed. 
Note: Participants on therapeutic anticoagulation must not be 
started on study before therapy is completed and prophylactic 
anticoagulation is established.
Immune System
17. History of severe hypersensitivity reactions to antibodies
18. Chronic systemic steroid therapy (> 10 mg daily prednisone 
or equivalent) or any other form of immunosuppressive 
therapy within seven days prior to the first dose of study 
treatment; topical, inhaled, nasal and ophthalmic steroids are 
not prohibited. Intermittent prophylaxis per site institutional 
policy is not prohibited as long as it does not exceed chronic 
daily use of >10 mg prednisone or equivalent eg prophylactic 
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use of steroids for Palmar Plantar Erythrodysesthesia (PPE) 
toxicity with PLD is allowed.
19.
History of autoimmune disease that has required systemic 
treatment with disease-modifying agents, corticosteroids, or 
immunosuppressive drugs unless in the opinion of the 
investigator the participant is in a complete and durable 
remission; physiologic replacement therapies, such as 
thyroxine, insulin, or physiologic corticosteroid replacement 
therapy for adrenal or pituitary insufficiency, is allowed
20.
Prior organ transplantation including allogeneic or 
autologous stem cell transplantation
Oncology
21.
Concurrent or previous other malignancy within two years 
of study entry with the exception of cured basal or squamous 
cell skin cancer, superficial bladder cancer, carcinoma in situ
of the cervix, other non-invasive or indolent malignancy, or 
surgically-excised malignancy that is considered cured 
22.
Concurrent enrollment in another therapeutic clinical study
23.
Prior treatment with anti-CD47 or anti-SIRPα therapy
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Objectives
Primary Objectives
•
Evaluate DLTs, safety and tolerability of escalating dose 
levels of PF-07901801 when administered in combination 
with 40 mg/m2 PLD in 28-day cycles and establish the 
MTD and RP2D combination regimen (Phase 1 portion of 
study)
•
Assess a preliminary evidence of anti-tumor activity of 
PF-07901801 in combination with 40 mg/m2 PLD (Phase 
2 portion of study)
Secondary Objectives
•
Further assess the overall safety profile of PF07901801 
administered in combination with 40 mg/m2 PLDAssess 
additional efficacy outcomes
Exploratory Objectives
•
Assess effect of treatment with PF-07901801 in 
combination with PLD on CA-125 levels
•
Characterize the PF-07901801 concentration in serum 
when administered in combination with PLD
•
Characterize the PLD concentration in plasma when 
administered in combination with PF-07901801 
•
Assess DDI potential between PF-07901801 and PLD
•
Evaluate development of antibodies directed against 
PF-07901801
•
Explore possible relationships between PF-07901801 
exposure and clinical outcome, safety and 
pharmacodynamics observations 
•
Understand the relationship between the therapeutic 
intervention(s) being studied and the biology of the 
participant’s disease.
Endpoints
Primary
•
DLTs during the DLT observation period (28 days 
following C1D1). Objective response (CR, PR) as defined 
by RECIST v1.1 criteria
Secondary
•
Overall safety profile as assessed by the type, frequency, 
severity, timing and causal relationship of any adverse 
events, changes in vital signs, ECG, serum chemistry or 
other laboratory assessment, treatment delays or 
discontinuations
•
PFS, OS, disease control (DC [CR or PR or SD]), and  
DOR). 
Exploratory
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•
Evaluate CA-125 levels in serial blood samples
•
Measurements of biomarkers/pharmacodynamics, which 
may consist of DNA, RNA, protein or defined cell types, 
resulting from analyses of peripheral blood and/or tumor 
tissue biospecimen obtained at baseline, on treatment 
and/or at end of study.
•
Immunogenicity: Incidence and titers of ADA and 
neutralizing antibodies against PF-07901801
•
PF-07901801 PK: Single and multiple dose Cmax, 
and clearance.
PLD PK: Single and multiple dose Cmax and Ctrough.
Drug Product PF-
07901801 (TTI-622)
 
 
 
 
and supplied at a 
concentration of 10 mg/mL in 20 mL single use Type I 
borosilicate glass vials with butyl rubber stoppers and aluminum 
seals. Each vial contains an extractable volume of 14 mL PF-
07901801 Drug Product. For administration to the participan, PF-
07901801 Drug Product is diluted with 0.9% sodium chloride for 
injection USP and administered by intravenous infusion. Please 
see the Investigational Product Manual (IPM) for preparation 
information. The dose of PF-07901801 will be based upon the 
dose level cohort to which the participant is assigned; the duration 
of infusion is dependent on dose level: dose levels less than or 
equal to 33 mg/kg infused over 60 min and doses greater than 33 
mg/kg infused over 90 minutes and will have doses equal to or 
less than 2500 mg in 250 mL and doses 2501 mg or more in 500 
mL or neat drug if the drug volume is over 500 mL .
In Cycle 1 for dose levels 12 mg/kg and 24 mg/kg only, PF-
07901801 will be administered on Day 1, Day 8, Day 15 and Day 
22 of a 28-day cycle. Beginning with Cycle 2, PF-07901801 will 
be administered on Day 1 and Day 15 of 28-day cycles. The 
enhanced dosing in Cycle 1 represents a loading cycle and is 
intended to allow PF-07901801 levels to more quickly reach 
steady state.
For dose level 48 mg/kg , PF-07901801 will be administered on 
Day 1 and Day 15 of 28-day cycle. Loading doses (Day 8 and 
Day 22) may be considered for Cycle 1 at the 48 mg/kg dose level 
if found to be safe and offer clinical benefit for participants. If 
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Cycle 1 loading doses are implemented, all dosing and lab draw 
schedules for the 48 mg/kg dose will follow the schedules for 
dose levels 12 mg/kg and 24 mg/kg.
On days when PF-07901801 and PLD are both administered, PLD 
will be administered prior to infusion of PF-07901801. On each 
day of PF-07901801 administration, a 60-minute observation 
period will follow PF-07901801 infusion and vital signs will be 
assessed at 30-minute intervals during this observation period; at 
the investigator’s discretion, the duration of the observation 
period may be decreased after completion of Cycle 1 for a 
participant who has not experienced infusion-related reaction.
Reference Product 
Pegylated 
Liposomal 
Doxorubicin (PLD)
Pegylated liposomal doxorubicin will be administered per the 
approved package insert. The IP Manual should be referenced for 
additional information.
The Single Reference Safety Document (SRSD) for PLD is the 
PLD (DOXIL®) US Product Insert (USPI).
Statistical 
Considerations 
Based on a standard 3+3 design, up to approximately six DLT-
evaluable participants may be enrolled in each dose level cohort 
during the Phase 1 dose escalation portion of the study; a 
minimum of nine and a maximum of 18 DLT-evaluable 
participants  is anticipated.
The Phase 2 expansion cohort is anticipated to provide a 
reasonable estimate of disease control, defined for this study as 
objective response rate among 25 treated participants, defined by 
RECIST v1.1 criteria, to support planning of future studies. The 
Phase 2 expansion cohort is planned to evaluate a PF-07901801 
dose level derived from the dose escalation portion of the study in 
combination with a fixed dose of PLD. In this hypothesis-
generating study, assuming an overall response rate of 10% with 
PLD monotherapy and an alternative of 30%, a power of 80% and 
one-sided Type 1 error set at 0.05, the combination will be 
considered worthy of further study if at least six responses are 
observed in the 25-participant cohort. 
Other evidence of clinical activity, such as duration of response, 
progression-free survival, and overall survival will be evaluated 
descriptively..
Dose Delays, Dose 
Modifications, 
Guidelines for 
Treatment 
Participants who enter the study with symptoms or laboratory 
values equivalent to NCI CTCAE Grade 1 or Grade 2 should not 
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Discontinuation 
and Study 
Withdrawal
have dose reductions related to the persistence or mild worsening 
of those symptoms or laboratory values.
Dose reductions may be warranted if worsening of symptoms or 
laboratory values is clinically significant in the opinion of the 
investigator and in the case of unacceptable treatment-related 
adverse events. Recognizing that it may be difficult to make 
attribution to one agent or the other in the combination regimen 
and in collaboration with the medical monitor, best efforts should 
be made to consider the underlying reason for the worsening of 
symptoms or development of a treatment-related adverse event so 
that dosing of the appropriate study drug can be modified.
Except in the case of proteinuria, asymptomatic laboratory 
abnormalities should not result in dose interruptions, 
modifications, or discontinuation of study therapy unless 
determined by the investigator to be clinically significant or 
life-threatening.
The investigator should withdraw a participant from all study-
related treatment for any of the following reasons:
•
An unacceptable adverse event or safety observation, such 
as a persistent moderate toxicity that is intolerable to the
participant, that is in the opinion of the investigator clearly 
attributed to PF-07901801
•
An unacceptable adverse event or safety observation, such 
as a persistent moderate toxicity that is intolerable to the 
participant, that is in the opinion of the investigator clearly 
attributed to PLD and the participant has received fewer 
than four cycles of PLD. A participant who has completed 
four cycles of PLD treatment and experiences an adverse 
event that requires discontinuation of PLD may continue 
on study receiving PF-07901801 monotherapy.
•
Any event which would cause PF-07901801 or PLD to be 
modified by more than two dose reductions or to be held 
for more than 42 days from the last administered dose and 
is not attributable to a particular agent of the combination 
regimen; exception is made for participants who are 
receiving meaningful disease control and the investigator 
feels, with medical monitor concurrence, that continued 
treatment is in the best interest of the participant
•
Any treatment-related adverse event that is deemed 
life-threatening, regardless of grade; exception is made for 
participants in whom the life-threatening adverse event is 
attributed to PLD and the participant has received at least 
four cycles of PLD treatment and the investigator feels, 
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with medical monitor concurrence, that continuation with 
PF-07901801 monotherapy would be reasonable. 
•
Documentation of objective (radiographic) disease 
progression; for participants with asymptomatic 
progression and in the absence of unacceptable toxicity, 
the participant should continue treatment and a 
confirmation scan should be conducted at least four weeks 
later to document objective progression prior to removing 
participant from study treatment. A participant should not 
be removed from study on the basis of change in CA-125 
level in the absence of objective or asymptomatic 
progression.
•
Unacceptable toxicity which in the opinion of the 
investigator cannot be attributed to a specific study agent
•
An intercurrent illness or change in the participant’s 
condition that renders the participant unsuitable for further 
treatment in the opinion of the investigator; exception may 
be made for participants in whom the intercurrent illness 
or change in condition is thought to render the participant 
ineligible for continued treatment with PLD and the 
participant has received at least four cycles of PLD and the 
investigator feels, with medical monitor concurrence, that 
continuation with PF-07901801 monotherapy would be 
reasonable and the participant meets criteria for PF-
07901801 re-treatment
•
Significant noncompliance with study protocol
•
Withdrawal of consent for participation in the treatment 
portion of the study (participant may participate in Long-
Term Follow-Up assessment of survival and disease status 
[if withdrawn prior to documentation of objective disease 
progression] if consent for Long-Term Follow-Up 
assessment is not withdrawn)
•
Termination of the study by the sponsor
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TABLE OF CONTENTS
1 PROTOCOL APPROVAL .....................................................................................................2
2 SYNOPSIS..............................................................................................................................3
LIST OF TABLES...................................................................................................................27
LIST OF FIGURES .................................................................................................................28
ABBREVIATIONS .................................................................................................................29
3 INTRODUCTION ................................................................................................................34
3.1 CD47 and Signal Regulatory Protein Alpha (SIRPα)..............................................34
3.2 Regulation of Macrophage Phagocytic Activity ......................................................34
..........................................................................................................35
3.4 Rationale for Patient Population and Study Design.................................................36
3.5 Investigational Medicinal Product PF-07901801.....................................................39
3.5.1 Nonclinical Experience with PF-07901801.................................................39
3.5.1.1 Nonclinical Pharmacology of PF-07901801..............................39
3.5.1.2 Nonclinical Pharmacokinetics of PF-07901801.........................40
3.5.1.3 Nonclinical Toxicology of PF-07901801...................................40
3.5.2 Clinical Experience with PF-07901801.......................................................42
3.5.2.1 Study C4971001.........................................................................42
...................45
3.5.2.3 Clinical Activity.........................................................................46
3.6 Investigational Medical Product Pegylated Liposomal Doxorubicin (PLD) ...........47
3.7 Rationale for Planned Regimens of Investigational Medical Products....................48
3.7.1 PF-07901801................................................................................................48
3.7.2 Pegylated Liposomal Doxorubicin ..............................................................48
3.8 Benefit-Risk Assessment..........................................................................................49
3.8.1 Expected Risks of PF-07901801 .................................................................49
3.8.2 Expected Benefits of PF-07901801.............................................................49
4 STUDY OBJECTIVES AND ENDPOINTS........................................................................50
4.1 Primary Objectives...................................................................................................50
4.2 Primary Endpoints....................................................................................................50
4.3 Secondary Objectives...............................................................................................50
4.4 Secondary Endpoints................................................................................................50
4.5 Exploratory Objectives.............................................................................................50
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4.6 Exploratory Endpoints..............................................................................................51
5 INVESTIGATIONAL PLAN...............................................................................................51
5.1 Overall Study Design ...............................................................................................51
5.2 Doses and Schedule of Administration of Investigational Agents...........................53
5.2.1 PLD 55
5.2.2 PF-07901801................................................................................................55
5.3 Criteria for Treatment Discontinuation....................................................................56
5.4 Dose-Limiting Toxicity Criteria for the Dose Escalation Portion of the Study.......58
6 STUDY POPULATION.......................................................................................................60
6.1 Number of Participants.............................................................................................60
6.2 Inclusion Criteria......................................................................................................60
6.3 Exclusion Criteria.....................................................................................................62
6.4 Re-Screening ............................................................................................................64
6.5 Waivers of Inclusion/Exclusion Criteria..................................................................64
6.6 Participants of Reproductive Potential.....................................................................65
7 ENROLLMENT PROCEDURE AND METHOD OF ASSIGNING SUBJECTS TO 
TREATMENT GROUPS....................................................................................................66
7.1 Enrollment Procedure...............................................................................................66
7.2 Method of Assigning Subjects to Treatment Groups...............................................66
8 DESCRIPTION OF STUDY TREATMENT.......................................................................66
8.1 PF-07901801 ............................................................................................................66
8.1.1 How Supplied ..............................................................................................67
8.1.2 Storage Conditions.......................................................................................67
8.2 Pegylated Liposomal Doxorubicin...........................................................................67
8.3 Preparation and Administration of Study Treatments..............................................67
8.3.1 PF-07901801................................................................................................67
8.3.2 Pegylated Liposomal Doxorubicin ..............................................................67
8.4 Pegylated liposomal doxorubicin will be administered per the approved 
package insert. The IP Manual should be referenced for additional 
information.Blinding of Treatment ...........................................................................67
8.5 Treatment Compliance .............................................................................................67
8.6 Study Drug Accountability.......................................................................................67
8.7 Concomitant Medications ........................................................................................68
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8.7.1 Concomitant Corticosteroids .......................................................................68
8.7.2 Concomitant Hematopoietic Growth Factors and Blood Products..............68
8.7.3 Concomitant Anti-Coagulants .....................................................................69
8.7.4 Prohibited Medications and Potential Drug-Drug Interactions ...................69
8.8 Treatment of Overdose.............................................................................................69
9 MONITORING AND MANAGEMENT OF EXPECTED OR POTENTIAL 
ADVERSE EVENTS..........................................................................................................70
9.1 Management of Adverse Events Associated with PF-07901801.............................71
9.1.1 PF-07901801 Treatment Interruptions ........................................................71
9.1.2 PF-07901801 Re-Treatment Guidelines......................................................71
9.1.3 PF-07901801 Dose Modification Guidelines..............................................71
9.1.4 Hematologic Adverse Events Related to PF-07901801 Administration.....72
9.1.5 Non-Hematologic Adverse Events Related to PF-07901801 
Administration .................................................................................................73
9.1.6 Management of Other Adverse Events Related to PF-07901801 
Administration .................................................................................................74
9.1.7 Grading and Management of Infusion-Related Reactions...........................74
9.2 Management of Adverse Events Associated with PLD ...........................................76
9.2.1 PLD Treatment Interruptions.......................................................................76
9.2.2 PLD Re-Treatment Guidelines ....................................................................76
9.2.3 PLD Dose Modification Guidelines ............................................................76
9.2.4 Management of Infusion-Related Reactions Associated with PLD ............77
9.2.5 Management of Cardiomyopathy Associated with PLD.............................78
9.2.6 Management of Hematologic Adverse Events Associated with PLD.........78
9.2.7 Management of Hand-Foot Syndrome Associated with PLD .....................78
9.2.8 Management of Stomatitis Associated with PLD........................................79
9.2.9 Secondary Oral Neoplasms Related to PLD Administration ......................80
9.2.10 Extravasation and Tissue Necrosis Related to PLD Administration.........80
9.3 Management of Adverse Events not Attributable to a Specific Study Treatment ...80
10 STUDY ASSESSMENTS ..................................................................................................82
10.1 Pharmacokinetics ...................................................................................................93
10.1.1 PF-07901801 Concentration......................................................................93
10.2 Immunogenicity Assessments................................................................................93
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10.2.1 Anti-PF-07901801 Antibody (ADA) and Neutralizing Anti-PF-
07901801 Antibody (NAb)..............................................................................93
10.3 Biomarker and Pharmacodynamics Assessments ..................................................94
11 SCHEDULE OF PROCEDURES AND ASSESSMENTS................................................94
12 STATISTICAL CONSIDERATIONS .............................................................................102
12.1 Sample Size..........................................................................................................102
12.1.1 Dose Escalation .......................................................................................102
12.1.2 Expansion Cohort ....................................................................................102
12.2 Analysis Populations............................................................................................102
12.3 Criteria for Evaluation..........................................................................................103
12.3.1 Safety.......................................................................................................103
................................103
................................104
12.3.4 Disease Control........................................................................................104
12.3.5 Biomarker and Pharmacodynamics Assessments....................................104
12.4 Statistical Methods ...............................................................................................104
13 SAFETY ...........................................................................................................................105
13.1 Definition of Adverse Events...............................................................................105
13.1.1 Adverse Event..........................................................................................105
13.1.2 Serious Adverse Event.............................................................................105
13.2 Clarifications to Serious Adverse Event Reporting .............................................106
13.3 Assessment of Causality.......................................................................................106
13.4 Assessment of Severity ........................................................................................107
13.5 Action Taken........................................................................................................108
13.5.1 Other Specific Treatments of Adverse Event..........................................108
13.5.2 Outcome of Adverse Event......................................................................108
13.5.3 Time Period and Frequency for Collecting AE and SAE Information....109
13.5.4 Documentation.........................................................................................109
13.5.5 Follow-Up................................................................................................110
13.5.6 Notification..............................................................................................111
13.5.7 Regulatory Reporting Requirements for SAEs........................................111
13.6 Adverse Events of Special Interest.......................................................................112
13.7 Lack of Efficacy...................................................................................................112
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13.8 Environmental Exposure,  Exposure during Pregnancy, or Breastfeeding, and 
Occupational Exposure............................................................................................112
13.8.1 Exposure During Pregnancy (EDP).........................................................112
13.8.2 Exposure During Breastfeeding (EDB)...................................................114
13.8.3 Occupational Exposure............................................................................114
13.8.4 Cardiovascular and Death Events............................................................114
13.8.5 Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs............................................................................114
13.9 Medication Error ..................................................................................................115
13.10 Laboratory Abnormalities ..................................................................................115
13.11 Sponsor Safety Review ......................................................................................116
13.12 Overview of Safety Monitoring .........................................................................116
14 ETHICAL AND ADMINISTRATIVE CONSIDERATIONS.........................................116
14.1 Regulatory Authority Approvals..........................................................................116
14.2 Institutional Review Board...................................................................................117
14.3 Confidentiality of Information .............................................................................117
14.4 Patient Informed Consent.....................................................................................118
14.5 Study Monitoring .................................................................................................118
14.6 Clinical Supplies ..................................................................................................119
14.7 Electronic Case Report Form ...............................................................................119
14.8 Study Termination and Site Closure ....................................................................119
14.9 Modification of the Study Protocol......................................................................120
14.10 Retention of Study Documents ..........................................................................120
14.11 Clinical Study Report.........................................................................................121
14.12 Study Publication ...............................................................................................121
14.13 Quality Assurance Audits...................................................................................121
14.14 Dissemination of Clinical Study Data................................................................121
14.15 Finance and Insurance........................................................................................122
14.16 Retention of Biological Specimens....................................................................122
15 REFERENCES .................................................................................................................123
19 APPENDIX D: LIVER SAFETY: SUGGESTED ACTION AND FOLLOW-UP 
ASSESSMENTS...............................................................................................................137
20 APPENDIX E: KIDNEY SAFETY: MONITORING GUIDELINES .............................139
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21 APPENDIX G: DOCUMENT HISTORY........................................................................141
SUMMARY OF CHANGES IN VERSION 2 ......................................................................142
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LIST OF TABLES
Table 1.
PF-07901801 Dose Levels and Enrollment by Cohort.........................................43
Table 2.
Adverse Events of Any Grade Regardless of Causality in ≥10% of 
Participants ...........................................................................................................43
Table 3.
Adverse Events of Any Grade Related to Treatment with PF-07901801 in 
≥5% of Participants...............................................................................................44
Table 4.
Grade 3 or Grade 4 Adverse Events Regardless of Causality in ≥5% of  
Participants ...........................................................................................................44
Table 5.
Grade 3 or Grade 4 Adverse Events Related to Treatment with PF-07901801....44
Table 6.
Serious Adverse Events Regardless of Causality in ≥5% of Participants ............45
...................................46
...................................46
Table 9.
Clinical Activity with PF-07901801 Monotherapy at Doses Ranging from 
0.8 – 18 mg/kg in Study TTI-622-01....................................................................47
Table 10.
PF-07901801 Dose Levels Planned for Evaluation in Combination with 
Doxorubicin..........................................................................................................48
Table 11.
Participants Dose-Grouping, Dose Escalation Plan..............................................54
Table 12.
PF-07901801 Dose Levels Planned for Evaluation in Combination with 
PLD.......................................................................................................................56
.................................66
Table 14.
Requirements for Re-Treatment with PF-07901801 ............................................71
Table 15.
PF-07901801 Dose Modifications........................................................................71
Table 16.
Management of Hematologic Adverse Events Associated with -PF-07901801 
Administration......................................................................................................72
Table 17.
Management of Non-Hematologic Adverse Events Associated with PF-
07901801 Administration.....................................................................................73
Table 18.
Management of other Treatment-Related Adverse Events...................................74
Table 19.
Definition of Infusion-Related Reaction by CTCAE Grade.................................74
Table 20.
Management of Infusion-Related Reactions Associated with PF-07901801 
Administration......................................................................................................75
Table 21.
Requirements for Re-Treatment with PLD...........................................................76
Table 22.
PLD Dose Modifications ......................................................................................76
Table 23.
Management of Infusion-Related Reactions Associated with PLD .....................77
Table 24.
Management of Hematologic Adverse Events Associated with PLD..................78
Table 25.
Management of Hand-Foot Syndrome Associated with PLD..............................79
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Table 26.
Management of Stomatitis Associated with PLD.................................................79
Table 27.
General Guidelines for Management of Adverse Events when Attribution is 
not Possible in the Opinion of the Investigator ....................................................81
Table 28.
Schedule of Assessment ......................................................................................83
Table 29.
Sample Collection Schedule for Analysis of PF-07901801 Concentration..........87
Table 30.
Sample Collection Schedule for Analysis of PLD Concentration........................88
Table 31.
Sample Collection Schedule for Analysis of PF-07901801 Anti-Drug 
Antibodies.............................................................................................................89
Table 32.
Sample Collection Schedule for Analysis of PF-07901801 
Biomarkers/Pharmacodynamics ...........................................................................90
LIST OF FIGURES
..........................................................35
..........................................................36
Figure 3.
The Effect of TTI-621 Monotherapy on Phagocytosis in Ovarian Cancer Cell 
Lines .....................................................................................................................38
Figure 4.
The Effect of TTI-621 Monotherapy on Ovarian Cancer Growth in 
Xenograft Models.................................................................................................38
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ABBREVIATIONS
ADA
anti-drug antibodies
ADCC
antibody-dependent cellular cytotoxicity
ADP
adenosine diphosphate
AE
adverse event
ALL
acute lymphoblastic leukemia 
ALT
alanine aminotransferase
AML
acute myeloid leukemia
ANC
absolute neutrophil count
ASCO
American Society of Clinical Oncology
AST
aspartate aminotransferase 
AUC
area under the curve
BSA
bovine serum albumin
BUN
blood urea nitrogen
CBP
childbearing potential
CDC
complement-dependent cytotoxicity
CK
creatine kinase
CKD
chronic kidney disease
CL
clearance rate of drug
CLL
chronic lymphocytic leukemia
Cmax
maximum blood concentration
COVID-19
coronavirus disease 2019
CNS
central nervous system
CR
complete response
CRO
contract research organization
CRF
case report form
CSR
Clinical Study Report
CT
computed tomography; clinical trial
CTCAE
Common Terminology Criteria for Adverse Events
CTCL
cutaneous T-cell lymphoma
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CTIS
Clinical Trials Information System
Cthrough
lowest concentration prior to next administration of drug
CV
coefficient of variation
CYP
cytochrome P450
D
day
DC
disease control
DCR
disease control rate
DDI
drug-drug interaction
DLBCL
diffuse large B-cell lymphoma
DILI
drug induced liver injury
DL-1 or Dose 
Level-1
dose Level minus 1
DL-2 or Dose 
Level-2
dose Level minus 2
DLT
dose-limiting toxicity
DOR
duration of response
EC50
effective half-maximal concentration
EC
ethics committee
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRCL
estimated creatinine clearance
eCRF
electronic case report form
EDB
exposure during breastfeeding
EDC
electronic data capture
EDP
exposure during pregnancy
eGFR
estimated glomerular filtration rate
ELISpot
enzyme-linked immune absorbent spot
EOC
epithelial ovarian cancer
EOI
end of infusion
EOT
end of treatment
EPI
epidemiology collaboration
EU
European Union
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EudraCT
European Union Drug Regulating Authorities Clinical Trials (European 
Clinical Trials Database)
FDA
Food and Drug Administration
FFPE
fresh-fixed paraffin embedded
FSH
follicle-stimulating hormone
FTC
fallopian tube carcinoma
G-CSF
granulocyte colony-stimulating factor
GCP
Good Clinical Practice
GGT
gamma glutamyl transferase
GLP
Good Laboratory Practice
GM-CSF
granulocyte-macrophage colony-stimulating factor
HBV
Hepatitis B virus
HCV
Hepatitis C virus
HFS
hand-foot syndrome
HIV
human immunodeficiency virus
HIPAA
Health Information Portability and Accountability Act
HL
Hodgkin lymphoma
HRT
hormone replacement therapy
ICF
informed consent form
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
IEC
Independent Ethics Committee
IgG1
immunoglobulin G1
IgG4
immunoglobulin G4
INR
International Normalized Ratio
IP
investigational product
IPM
Investigational Product Manual
IRB
Institutional Review Board
IRR
infusion-related reaction
IV
intravenous(ly)
LDH
lactate dehydrogenase
LFT
liver function test
LVEF
left ventricular ejection fraction
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MDS
myelodysplastic syndromes
MedDRA
Medical Dictionary for Regulatory Activities
MHC
major histocompatibility complex
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
MUGA
multigated acquisition
NAb
neutralizing antibodies
NBF
neutral-buffered formalin
NCI
National Cancer Institute
NCCN
National Comprehensive Cancer Network
ND
not determined
NE
not evaluable
NGS
next-generation sequencing
NHL
non-Hodgkin lymphoma
NOS
not otherwise specified
NSAID
nonsteroidal anti-inflammatory drug
ORR
overall response rate
OS
overall survival
PARP
poly ADP ribose polymerase
P-gp
P-glycoprotein
PD
pharmacodynamics; progressive disease
PD-1
programmed death-1
PD-L1
programmed death ligand-1
PET
positron emission tomography
PFS
progression-free survival
PK
pharmacokinetics
PLD
pegylated liposomal doxorubicin
PPC
primary peritoneal carcinomas
PPE
palmar plantar erythrodysesthesia
PPRIF
Pregnant Partner Release of Information Form
PR
partial response
PS
performance status
PSSA
Pfizer SAE Submission Assistant
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PT
prothrombin time
PTT
partial thromboplastin time
PTCL
peripheral T-cell lymphoma
RBC
red blood cell
RECIST
Response Evaluation Criteria in Solid Tumours
RP2D
recommended Phase 2 dose
SAE
serious adverse event
SAP
Statistical Analysis Plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SCr
serum creatinine
Scys
serum cystatin C
SD
stable disease
SFU
safety follow up
SIRPα
signal regulatory protein alpha
SoA
schedule of activities
SOP
standard operating procedure
SRSD
Single Reference Safety Document
SUSAR
suspected unexpected serious adverse reaction
t½
terminal half-life
TAM
tumor-associated macrophage
T bili
total bilirubin
TCR
T-cell receptor
TCRVβ
variable beta chain of the T-cell receptor
TEAE
treatment-emergent adverse event
Tmax
time to Cmax
TK
toxicokinetic
ULN
upper limit of normal
US
United States
USP
United States Pharmacopeia
USPI
United State Prescribing Information
VTE
venous thromboembolism
WBC
white blood cell
WOCBP
women of childbearing potential
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3 INTRODUCTION
3.1 CD47 and Signal Regulatory Protein Alpha (SIRPα)
CD47 is a transmembrane glycoprotein normally expressed on all hematopoietic cells and 
additionally on epithelial and mesenchymal cells in many tissues.14,15 CD47 binds several 
integrin proteins and the extracellular matrix protein thrombospondin-1 and is involved in a 
wide variety of physiologic processes including platelet and neutrophil activation, T-cell 
function, regulation of vascular signaling by nitric oxide, inhibition of dendritic cell activity, 
and inhibition of monocyte activation.16-21
Hematologic malignancies have been shown to have high expression of CD47, including 
non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic 
leukemia (CLL), multiple myeloma, acute myeloid leukemia (AML) and myelodysplastic 
syndromes (MDS).22-28 Solid tumors have also been found to display high CD47 expression, 
including brain, breast, colon, gastric, kidney, soft tissue sarcomas including leiomyosarcoma, 
osteosarcoma liver, lung, melanoma, ovarian, pancreatic, and prostate tumors.6-10 In many of 
these cases, high expression of CD47 is associated with poor prognosis.
3.2 Regulation of Macrophage Phagocytic Activity
Macrophage-mediated phagocytosis is regulated by both activating (“eat”) and inhibitory (“do 
not eat”) signals. Of the latter, the best characterized inhibitory signal is CD47, which 
suppresses phagocytosis by binding SIRPα on the surface of macrophages.30 Upon binding to 
CD47, immunoreceptor tyrosine-based inhibitor motifs in the cytoplasmic tail of SIRPα 
become phosphorylated, resulting in recruitment and activation of downstream phosphatases, 
including SHP-1 and SHP-2, ultimately leading to inhibition of phagocytosis. The inhibition is 
thought to be mediated through deactivation of the contractile cytoskeletal activity involved in 
pulling the target cell into a macrophage for ingestion.31 Interestingly, this strategy of immune 
evasion is used by both differentiated cancer cells and cancer stem cells.32
As noted above, elevated expression of CD47 has been correlated with poor clinical outcome. 
For example, overall survival was significantly lower for diffuse large B-cell lymphoma 
(DLBCL) or mantle cell lymphoma patients who had elevated CD47 expression.23 CD47 
expression was independently prognostic of DLBCL disease progression per multivariate 
analyses incorporating key prognostic factors. Similarly, patients with CLL that expressed high 
levels of CD47 experienced a significantly worse event-free survival compared with those 
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whose tumor expressed lower expression levels.23 Similar trends have been reported in other 
hematologic malignancies22,24,26 and in solid tumors.8,10,33,34 Indeed, evidence exists that 
increased CD47 expression may be involved in the transition from low-risk to high-risk MDS 
and possible transformation to AML.27 These findings are consistent with tumor cells 
exploiting the suppressive CD47-SIRPα axis to evade macrophage-mediated destruction. 
Blocking CD47 has emerged as a therapeutic strategy and several anti-CD47 developmental 
programs are underway to explore this approach.
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3.4 Rationale for Patient Population and Study Design 
Ovarian cancer is the second most common gynecologic malignancy in developed countries 
and the third most common gynecologic malignancy in developing countries. The majority 
(95%) of ovarian malignancies are epithelial in nature.1,2,3
High-grade serous carcinoma, the most common histologic subtype, generally includes 
fallopian tube and peritoneal serous carcinoma, based upon similarities in histology and 
clinical behavior. Epithelial cancers of ovarian, fallopian tube, and peritoneal origin exhibit 
similar clinical characteristics, behavior, and in many cases, share basic biology. As such, these 
are often considered collectively and define epithelial ovarian cancer (EOC) in clinical trials 
and clinical practice.
Despite initial therapy (usually consisting of surgical cytoreduction and platinum-taxane 
combination therapy), the majority of patients with advanced-stage ovarian cancer will relapse 
and require additional treatment. Patients with platinum-sensitive recurrent EOC, defined as 
recurrence at least 6 months after completion of prior-platinum-based treatment, are more 
likely to respond to retreatment with a chemotherapy regimen that contains a platinum. In 
addition, several trials suggest that patients with platinum-sensitive disease achieve better 
response rates and progression-free survival with maintenance treatment, which may consist of 
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bevacizumab, olaparib or niraparib, although only bevacizumab has shown an overall survival 
benefit. 
Patients with platinum-resistant recurrent EOC, defined as disease progression ≤6 months after 
the most recent-platinum-based treatment regimen (versus platinum-refractory disease, defined 
as progression while on therapy or within three months of completing their primary first-line 
platinum-based treatment), present with disease that is generally not curable and treatments 
should aim to maximize quality of life while attempting to control disease. Thus, this setting is 
an urgent unmet medical need and current treatment options typically consist of single-agent 
chemotherapy, including weekly paclitaxel or pegylated liposomal doxorubicin (PLD). In the 
AURELIA study, patients who received PLD at 40 mg/m2 experienced a median PFS of 4 
months and 8% ORR.4,5 Some patients are candidates for combination therapy with 
bevacizumab, which consistently results in better outcomes compared to chemotherapy alone, 
but this regimen is limited to those who did not receive bevacizumab in the platinum-sensitive 
setting and who have not had recent (prior 6 months) bowel obstruction and do not have 
malignant bowel involvement. The addition of bevacizumab to PLD in the AURELIA study 
raised the ORR to only 14% and the mPFS to 5 months, highlighting the need for more 
effective treatments – treatments that offer disease control without increased toxicity – for this 
patient population.4,5
PF-07901801 is a recombinant soluble fusion protein designed to block the cell-surface protein 
CD47, which is found on the surface of many normal cell types and at high levels on many 
malignant tumor cells.
 
 
 
Many solid tumors, including ovary, brain, breast, colon, gastric, kidney, soft tissue sarcoma, 
liver, lung, melanoma, pancreatic, and prostate tumors have also been found to express high 
levels of CD47.6-10 In many of these cases, high expression of
 
 
. CD47 protein is highly expressed in ovarian cancer 
and is correlated with poor clinical characteristics and prognosis.11,12 Decreasing CD47 levels
in an ovarian cancer cell lines resulted in promotion of macrophage phagocytosis and tumor 
growth in vivo.12
 
 
.13
Trillium’s CD47-targeted molecule TTI-621 significantly inhibits the growth of ovarian cancer 
cells in xenograft models, enhances phagocytosis and improves survival, as shown in Figure 3
and Figure 4. TTI-621 is very similar to PF-07901801, with the only difference being 
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replacement of the IgG4 domain in PF-07901801 with an IgG1 domain to generate TTI-621, 
and thus serves to demonstrate the intended effect of CD47-mediated targeting in cancer.
Figure 3.
The Effect of TTI-621 Monotherapy on Phagocytosis in Ovarian Cancer Cell 
Lines
The effect of TTI-621 monotherapy on phagocytosis in ovarian cancer cell lines and tumor growth and survival in TOV-21G 
and SKOV-3 xenograft models of ovarian cancer In vitro phagocytosis of OVCAR-3 and TOV-21G cell lines was 
evaluated in the presence of 1 μM TTI-621 or control Fc (left panel). To evaluate tumor growth and animal 
survival, NOD/SCID mice were implanted intraperitoneally with TOV-21G or SKOV-3 cells and treated with 
TTI-621 at 10mg/kg, as indicated by the inverted triangles in the middle panels. Tumor growth curves, measured 
by BLI, are shown in the middle panels; survival curves are shown on the right panels.
Figure 4.
The Effect of TTI-621 Monotherapy on Ovarian Cancer Growth in Xenograft 
Models
The effect of TTI-621 monotherapy on ovarian cancer growth in xenograft models: NOD/SCID mice received 
intraperitoneal implants of luciferase-expressing OVCAR-3 cells. On Day 27 after implant, animals were 
randomized to TTI-621 or vehicle control administered intraperitoneally at 10 mg/kg three times per week for two 
weeks. Tumor burden was assessed by bioluminescence on Day 27 (left panel) and again on Day 78, 
approximately one month after cessation of treatment (middle panel). In the right panel, representative 
bioluminescence images at Day 27 and Day 50 are shown (upper panels: vehicle control; lower panels: TTI-621).
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The combination of CD47-blockade and doxorubicin, the active component of liposomal 
doxorubicin, has been shown to enhance anti-tumor activity in multiple solid tumor models, 
including ovarian, breast and hepatocellular carcinoma.13, 35-36 In an invasive breast cancer 
model, anti-CD47 antibody therapy enhanced the effect of doxorubicin by reducing tumor 
growth and metastatic spread to the lungs.35 This anti-tumor effect was associated with 
increased macrophage-mediated killing of breast cancer cells. Moreover, CD47 blockade was 
found to protect against doxorubicin-induced cytotoxicity by enhancing cardiac tissue viability 
and function in mice. This cytoprotective effect was attributed to an increase in autophagic 
flux. In another study, CD47 blockade enhanced macrophage-mediated phagocytosis of 
hepatocellular carcinoma cell lines in the presence of doxorubicin in vitro.36
Together, these studies suggest that combining PF-07901801 with doxorubicin-based 
chemotherapy may be more effective than doxorubicin-based chemotherapy alone in tumor 
types that have high CD47 expression and have high numbers of macrophages, such as ovarian 
cancer.
An ongoing clinical trial of PF-07901801 in participants with advanced hematologic 
malignancies, including lymphoma, leukemia and multiple myeloma (Protocol TTI-622-01, 
NCT03530683) has demonstrated the safety of weekly infusions of PF-07901801. As of the 
cut-off date of 12 April 2021, 43 participants with advanced relapsed/refractory lymphoma 
have received PF-07901801 at doses ranging from 0.05 mg/kg to 18.0 mg/kg. A single DLT, 
reversible asymptomatic Grade 4 platelet count decrease was observed and managed without 
any clinical sequelae. No treatment-related serious adverse events have been reported. The 
favorable safety profile of PF-07901801 suggests that combining PF-07901801 with other 
therapies might offer an effective treatment option for patients without the addition of 
prohibitive toxicity. Thus, the primary goal of this clinical trial is to evaluate the safety and 
activity of PF-07901801 administered in combination with the standard of care PLD regimen 
in participants with platinum-resistant recurrent EOC. The safety and activity of escalating 
doses of PF-07901801 administered in combination with PLD administered at 40 mg/m2 on 
Day 1 of 28-day cycles will be evaluated in the first part of this study and a maximum tolerated 
dose or recommended Phase 2 regimen will be identified; an expansion cohort will then be 
enrolled to evaluate the safety and activity of the maximum tolerated dose or recommended 
Phase 2 regimen with the goal of establishing a basis for subsequent clinical evaluations. 
3.5 Investigational Medicinal Product PF-07901801 
3.5.1 Nonclinical Experience with PF-07901801 
3.5.1.1 Nonclinical Pharmacology of PF-07901801 
TTI-622/PF-07901801 was evaluated in a series of studies that have collectively demonstrated 
the following:
•
PF-07901801 bound to human hematopoietic tumor cell lines and primary tumor 
samples with an effective half-maximal (EC50) concentration of 140–924 nM (average: 
361 ± 294 nM or 27.8 ± 22.7 μg/mL). Comparable binding of PF-07901801 was 
observed on normal human blood cells with the exception of RBCs, to which only 
minimal binding was observed
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•
PF-07901801 cross-reacted with cynomolgus monkey CD47 and bound stronglyto 
monkey RBCs
•
PF-07901801 induced macrophage-mediated phagocytosis of a range of hematologic
and solid tumor cell lines and primary participant samples with an average EC50 value
of 8 nM (0.6 μg/mL)
•
Although phagocytosis of some normal cells such as platelets was observed, 
competition studies suggest that PF-07901801 triggers macrophages to selectively 
phagocytose tumor cells over normal cells
•
PF-07901801 exhibited anti-leukemic activity in an AML xenograft model and was 
highly effective in reducing tumor burden and prolonging survival in a DLBCL 
xenograft tumor model and in a head and neck cancer xenograft model when combined 
with the anti-EGFR antibody cetuximab. PF-07901801 potentiated the efficacy of 
daratumumab by reducing the tumor volume and increasing survival in Burkitt 
lymphoma and multiple myeloma xenograft models
•
PF-07901801 did not induce ADCC or CDC against tumor cells
•
PF-07901801 did not trigger biologically relevant inhibition or activation of platelet 
aggregation at concentrations of up to 300 μg/mL in human whole blood or platelet rich
plasma
Additional information and details of these studies may be found in the Investigator’s 
Brochure.
3.5.1.2 Nonclinical Pharmacokinetics of PF-07901801 
Four toxicokinetic (TK) studies were performed to characterize the TK properties of PF-
07901801 in the cynomolgus monkey. The studies included two 4-week studies, a 4-week 
repeat-dose dose range finding study, and a 4-week repeat-dose GLP study. Across the studies, 
male and female cynomolgus monkeys received once weekly, twice weekly, or biweekly 
intravenous administrations of PF-07901801 at dose levels of 1, 3, 5, 8 or 12.5 mg/kg/dose.
Overall, the results of the TK studies indicated that when not affected by anti-drug antibodies, 
PF-07901801 exposure generally increased in a dose-proportional or greater than dose-
proportional manner across dose levels ranging from 1 to 8 mg/kg/dose. Comparison between 
first and last dose indicated PF-07901801 accumulation up to 1.6-fold, indicating that exposure 
was maintained throughout the studies despite the development of anti-drug antibodies in the 
majority of animals.
Additional information may be found in the Investigator’s Brochure.
3.5.1.3 Nonclinical Toxicology of PF-07901801 
The safety of PF-07901801 was evaluated in four non-human primate repeat-dose toxicology 
studies in the cynomolgus monkey (Macaca fascicularis) in which CD47 has 98% sequence 
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homology with human CD47; in addition, PF-07901801 cross-reacts with CD47 and binds to 
red blood cells from this species. Three non-GLP dose range finding studies supported a GLP 
repeat-dose toxicity study. Across all four studies a total of 69 animals were dosed with PF-
07901801 across a range of concentrations.
The GLP study in male and female cynomolgus monkeys was designed as a five-week study 
with either a once or twice weekly intravenous infusion of PF-07901801 at dose levels of 0 
(vehicle control) or 1, 3, 5, or 8 mg/kg (8 mg/kg dose weekly administration only). Two 
animals/sex from the 0 (vehicle control), 5 mg/kg weekly, 8 mg/kg weekly and 5 mg/kg twice 
weekly dose groups were maintained for a four-week recovery period to assess the 
reversibility, persistence, and delayed occurrence of any effects.
Parameters evaluated included mortality, clinical signs, body weight; ophthalmoscopic, 
neurological, and electrocardiographic examinations; blood pressure and respiratory rate 
measurements; clinical pathology (hematology, coagulation, clinical chemistry, and 
urinalysis); anatomic pathology; toxicokinetics and immunogenicity. To further evaluate 
adverse effects of PF-07901801 and provide insight into the mechanism of toxicity, circulating 
immune complexes, complement activation, cytokine release, and immunohistochemistry 
assessments were also conducted.
Of the 54 animals dosed with PF-07901801 in this study, three were sacrificed at unscheduled 
intervals due to moribund condition or were found dead, including two males administered 3 
mg/kg PF-07901801 once weekly. One of these animals was sacrificed in extremis on Day 15 
after the completion of the third dose and the other animal was found dead on Day 15, 30 
minutes following completion of the third dose. The third animal that died was from the 5 
mg/kg twice weekly group; the animal expired during infusion of the seventh dose on Day 22. 
Clinical observations for the male that died in extremis included decreased activity, shallow 
breathing, hunched posture and red discharge/vomitus. The cause of death was pulmonary 
hemorrhage in the lungs. No clinical observations were noted for the other two animals at the 
time of death, nor were there any histopathological findings and the cause of death was 
undetermined. All three animals tested positive for anti-drug antibodies and had increased 
levels of IgG, IgM, and/or C3 compared to control animal; therefore, immune complex-
mediated reactions may have been associated with the deaths.
Two males administered PF-07901801 at 5 mg/kg twice weekly were placed on a dosing 
holiday on Day 18 due to decreased red cell mass. Dosing was resumed on Day 22; however, 
the 5 mg/kg twice weekly dose level was considered to have exceeded the HNSTD (highest 
non-severely toxic dose). Findings in the other surviving animals were consistent with PF-
07901801 related effects on RBCs and included mild-to-moderate decreases in red cell mass 
with increases in spherocytes and evidence of a regenerative erythroid response indicated by 
increases in reticulocytes. Mild decreases in platelet counts were also noted in males at 8 
mg/kg (once weekly) and 3 mg/kg (twice weekly).
There was also a notable increase in complement components C4a and C3a in all PF07901801 
-treated males and in females treated at doses ≥3 mg/kg; no dose response relationship was 
evident. Evidence of a mild-to-moderate inflammatory stimulus was observed in both sexes at 
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all dose levels, as indicated by decreases in albumin, albumin to globulin ratios, and increases 
in fibrinogen, globulin, ferritin, C-reactive protein, and pro- inflammatory cytokines.
Overall, there were no microscopic correlates for any of the clinical pathology changes and all 
changes generally resolved by the recovery necropsy.
At the end of the dosing period, the majority of surviving animals tested positive for anti-drug 
antibodies (27/30 animals receiving weekly dosing and 16/21 animals receiving twice weekly 
doses); the presence of anti-drug antibodies correlated with a decrease in systemic exposure. In 
the recovery animals, two males and two females at 5 and 8 mg/kg (once weekly) tested 
positive for anti-drug antibodies on Day 58. In animals administered PF-07901801 twice 
weekly, two of the four recovery animals at 5 mg/kg screened positive for anti-drug antibodies, 
1 each on Day 54 and 58.
In the toxicokinetic portion of the study, systemic exposure (Cmax and AUC0-25 and/or AUCall) 
increased in a greater than dose proportional manner. Systemic exposure (AUC0-25) was 
variable and generally appeared to decrease following repeat administration. These variable 
results may indicate a potential impact from the immune response.
Based on the magnitude and reversibility of changes associated with PF-07901801, the 
HNSTD for the pivotal GLP toxicity study was determined to be 8 mg/kg (once weekly) or 3 
mg/kg (twice weekly).
Additional information for each toxicology study is found in the Investigator’s Brochure.
3.5.2 Clinical Experience with PF-07901801 
3.5.2.1 Study C4971001 
PF-07901801 is being evaluated in an ongoing Phase 1  two-part, multicenter, open-label, dose 
escalation and expansion study in participants with advanced hematologic malignancies, 
including lymphoma, leukemia and multiple myeloma. In the Phase 1a dose escalation portion 
of the study, participants with advanced relapsed/refractory lymphoma are enrolled in 
sequential dose cohorts to receive PF-07901801 monotherapy by intravenous infusion over one 
hour once weekly to characterize the safety, tolerability and pharmacokinetics of PF-07901801 
and to determine the maximum tolerated dose (MTD) and Phase 1b starting dose for this 
schedule. In the Phase 1b portion of the study, participants with advanced refractory 
hematologic malignancies will be treated with PF-07901801 in combination with selected 
approved anti-cancer agents in several cohorts to further define safety and to characterize 
efficacy.
The study is ongoing and the data presented here are based on a data cut-off of 12 April 2021.
3.5.2.1.1 Enrollment and Demographic Summary
Enrollment into the Phase 1a portion of the study is presented in Table 1; no participants have 
been enrolled into the Phase 1b portion of the study as of the data cut-off date.
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As this was a first-in human study and PF-07901801 is a recombinant molecule, the possibility 
of infusion-related reaction was not unexpected. Therefore, a conservative dosing schema in 
which a two-week safety run-in with a lower dose prior full dosing was incorporated as noted 
in the table. In the complete absence of infusion-related reactions or dose-limiting toxicities in 
Cohorts 1-5, the safety run-in was deemed unnecessary and was eliminated beginning with 
Cohort 6.
Table 1.
PF-07901801 Dose Levels and Enrollment by Cohort
1
0.1 mg/kg
0.05 mg/kg
4
2
0.3 mg/kg
0.2 mg/kg
3
3
0.8 mg/kg
0.4 mg/kg
4
4
2.0 mg/kg
1.0 mg/kg
4
5
4.0 mg/kg
2.0 mg/kg
4
6
8.0 mg/kg
n/a
8
7
12.0 mg/kg
n/a
5
8
18.0 mg/kg
n/a
11
The majority of participants were white (29, 67%) and 9 (21%) identified as black or African 
American. The majority were female (24, 56%). The median age was 67 years (range, 24 to 86 
years). The majority of participants  had a diagnosis of Non-Hodgkin Lymphoma (37, 86%), 
with 19 (51%) of the participants with NHL having the DLBCL form. One patient was 
determined after enrollment to have Erdheim-Chester disease and was allowed to remain on 
study. The remaining 5 participants (12%) had a diagnosis of Hodgkin Lymphoma.
3.5.2.1.2 Safety 
3.5.2.1.2.1 Treatment-Emergent Adverse Events
Overall, 37 participants (86%) experienced at least one treatment-emergent adverse event. 
Adverse events reported in at least 10% of  participants are summarized in Table 2.
Table 2.
Adverse Events of Any Grade Regardless of Causality in ≥10% of 
Participants
Adverse Event
Number of Participants  (Percent)
Any
37 (86%)
Thrombocytopenia
13 (30%)
Constipation
8 (19%)
Nausea
8 (19%)
Pyrexia
7 (16%)
Fatigue
6 (14%)
Neutropenia
6 (14%)
Diarrhoea
5 (12%)
3.5.2.1.2.2 Treatment-Emergent Adverse Event Related to Treatment with PF-07901801 
Overall, 20 participants (47%) experienced at least one treatment-emergent adverse event that 
was assessed by the investigator as related to treatment with PF-07901801. Adverse events 
assessed as related to treatment and reported in at least 5% of participants are summarized in
Table 3. 
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Table 3.
Adverse Events of Any Grade Related to Treatment with PF-07901801 in 
≥5% of Participants
Adverse Event
Number of Participants  (Percent)
Any
20 (47%)
Thrombocytopenia
9 (21%)
Neutropenia
5 (12%)
Anemia
4 (9%)
Fatigue
4 (9%)
Nausea
3 (7%)
Abdominal pain
2 (5%)
ALT increased
2 (5%)
Blood alkaline phosphatase increased
2 (5%)
Chills
2 (5%)
Pyrexia
2 (5%)
3.5.2.1.2.3 Adverse Events Grade 3 or Grade 4 Regardless of Causality
Overall, 16 participants (37%) experienced at least one adverse event Grade 3 or Grade 4. 
Grade 3 or Grade 4 adverse events reported in at least 5% of participants are summarized in 
Table 4.
Table 4.
Grade 3 or Grade 4 Adverse Events Regardless of Causality in ≥5% of  
Participants
Adverse Event
Number of  Participants (Percent)
Any
16 (37%)
Neutropenia
5 (12%)
Thrombocytopenia
5 (12%)
Pneumonia
2 (5%)
3.5.2.1.2.4 Adverse Events Grade 3 or Grade 4 Related to Treatment with PF-07901801 
Overall, 6 participants (14%) experienced at least one Grade 3 or Grade 4 adverse event that 
was assessed by the investigator as related to treatment with PF-07901801. All Grade 3 or 
Grade 4 adverse events assessed as related to treatment are summarized in Table 5.
Table 5.
Grade 3 or Grade 4 Adverse Events Related to Treatment with PF-
07901801
Adverse Event
Number of Participants  (Percent)
Any
6 (14%)
Neutropenia
4 (9%)
Thrombocytopenia
2 (5%)
Anemia
1 (2%)
3.5.2.1.2.5 Serious Adverse Events Regardless of Causality
Overall, 9 participants (21%) experienced at least one serious adverse event. Serious adverse 
events reported in at least 5% of participants are summarized in Table 6.
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Table 6.
Serious Adverse Events Regardless of Causality in ≥5% of Participants
Adverse Event
Number of Participants  (Percent)
Any
9 (21%)
Pyrexia
4 (9%)
Pneumonia
2 (5%)
3.5.2.1.3 Serious Adverse Events Related to Treatment with PF-07901801 
No participant treated with PF-07901801 has experienced a serious adverse event assessed by 
the investigator as related to treatment with PF-07901801.
3.5.2.1.4 Adverse Events of any Grade Resulting in Death
One participant enrolled in Study TTI-622-01/C4971001 experienced adverse events unrelated 
to treatment with PF-07901801 that led to death. The participant, diagnosed with 
relapsed/refractory angioimmunoblastic T cell lymphoma, was enrolled into Cohort 4 (PF-
07901801 weekly at 2.0 mg/kg) and received a total of 10 infusions of PF-07901801 between 
Day 1 and Day 92. The participant came off study on Day 99 due to an unrelated periorbital 
infection, was hospitalized for this and subsequently developed multiple organ dysfunction 
syndrome and acute respiratory distress syndrome, and expired 23 days after discontinuing 
from the study. The investigator assessed these adverse events as unrelated to treatment with 
PF-07901801 and assessed them as related to the disease under study. 
No other participant enrolled in the study has experienced either of these adverse events.
3.5.2.1.5 Dose-Limiting Toxicity
The dose level of 8.0 mg/kg was associated with a reversible dose-limiting toxicity of Grade 4 
platelet count decreased in one participant, which was asymptomatic, reversible and managed 
without any clinical sequelae. This cohort was expanded and no other participant experienced 
this or any other dose-limiting toxicity. 
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3.5.2.3 Clinical Activity
PF-07901801 has demonstrated single agent clinical activity in some of the 43 participants
with advanced relapsed/refractory lymphoma enrolled in TTI-622-01/C4971001. To date, a 
33% ORR has been observed in 27 response-evaluable participants enrolled across doses 
ranging from 0.8 – 18 mg/kg. There appears to be a fast onset of response, with PR or CR 
noted by Week 8 of treatment in this patient population. 
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Among responding participants there were two complete responses and one near-CR:
•
One participant with DLBCL and four prior lines of therapy treated with PF-07901801 
at 0.8 mg/kg experienced PR at Week 8 and CR at Week 36. At more than 22 months 
since initiation of treatment, the participant remains on study in CR without disease 
progression under a modified treatment regimen of a single infusion per month.
•
One participant with CTCL with large cell transformation and six prior lines of therapy 
treated with PF-07901801 at 18 mg/kg experienced a CR at Week 8; the participant 
continues on study under a reduced schedule of one infusion every 21 days.
•
A third participant, with DLBCL and three prior regimens treated with PF-07901801 at 
4 mg/kg, had a 100% reduction in target lesions at Week 8 but was declared PR due to 
minimal residual signal on PET imaging. The participant continued on study and 
developed disease progression at Week 24.
Clinical activity with PF-07901801 as of the data cut-off of 12 April 2021 is summarized in 
Table 9. 
Table 9.
Clinical Activity with PF-07901801 Monotherapy at Doses Ranging from 
0.8 – 18 mg/kg in Study TTI-622-01
Indication
Response-Evaluable 
Participant Population (N)
CR
PR
ORR
DLBCL
11
1 (9%)
2 (18%)
3 (27%)
PTCL
6
0 (0%)
2 (33%)
2 (33%)
CTCL
4
1 (25%)
2 (50%)
3 (75%)
FL
3
0 (0%)
1 (33%)
1 (33%)
HL
3
0 (0%)
0 (0%)
0 (0%)
Total
27
2 (7%)
7 (26%)
9 (33%)
3.6 Investigational Medical Product Pegylated Liposomal Doxorubicin (PLD)
Pegylated liposomal doxorubicin (doxorubicin hydrochloride liposome injection) is an 
anthracycline topoisomerase inhibitor indicated for ovarian cancer after failure of platinum-
based chemotherapy and in other indications. PLD is one of a class of drug formulations that is 
delivered in liposome vesicles, in which the doxorubicin molecules are encapsulated in a 
bilayer sphere of lipids, which are then surrounded by a dense layer of polyethylene glycol 
(PEG), hence the name pegylated liposomal doxorubicin. The size of the liposomes, 
approximately 100 nm, prevents them from entering tissues with tight capillary junctions, such 
as the heart and gastrointestinal tract, leading to an improved safety profile when compared to 
the parent compound doxorubicin. The parent compound doxorubicin is a widely-used 
component of multi-agent adjuvant chemotherapy for many oncologic indications. 
Refer to the current Full Prescribing Information for information on the safety and clinical 
activity of pegylated liposomal doxorubicin. 
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3.7 Rationale for Planned Regimens of Investigational Medical Products
3.7.1 PF-07901801 
In the Phase 1 dose escalation portion of the study, increasing doses of PF-07901801 will be 
evaluated in combination with fixed-dose PLD in a standard 3+3 dose escalation scheme. 
Three dose levels will be evaluated starting with 12.0 mg/kg (Dose Level 1) administered by 
intravenous infusion over one hour. In Cycle 1 for dose levels 1 and 2, PF-07901801 will be 
administered on Day 1, Day 8, Day 15 and Day 22 in combination with PLD on Day 1 of 28-
day cycle. Beginning with Cycle 2 at dose levels 1 and 2, PF-07901801 will be administered 
on Day 1 and Day 15 in combination with PLD on Day 1 of 28-day cycles. The enhanced 
dosing in Cycle 1 represents a loading cycle and is intended to allow PF-07901801 levels to 
more quickly reach steady state. For dose level 3, PF-07901801 will be administered on Day 1 
and Day 15 in combination with PLD on Day 1 of 28-day cycles.
Prior treatment with doxorubicin or other anthracyclines’ equivalents at total cumulative doses 
must not be greater than 320 mg/m2 for doxorubicin, and calculated using doxorubicin 
equivalent doses: 1 mg doxorubicin= 1 mg pegylated liposomal doxorubicin (PLD)= 1.8 mg 
epirubicin= 0.3 mg mitoxantrone= 0.25 mg idarubicin.
The planned dose levels are presented in Table 10.
Table 10.
PF-07901801 Dose Levels Planned for Evaluation in Combination with 
Doxorubicin
Dose Level
PF-07901801 Dose
1
12mg/kg
2
24 mg/kg
3
48 mg/kg
If Dose Level 1, 12 mg/kg, is found to be intolerable, a lower dose level may be evaluated. If 
Dose Levels 2 or 3 are not tolerated, intermediate dose levels may be evaluated.
As described in Section 3.5.2, PF-07901801 dose levels up to 18 mg/kg administered weekly 
were found to be safe and well-tolerated in Study TTI-622-01/C4971001, the two-part, 
multicenter, open-label, Phase 1a/1b dose escalation and expansion study of PF07901801 in 
participants with advanced hematologic malignancies, including lymphoma, leukemia and 
multiple myeloma. The study in participants with ovarian cancer plans to administer PF-
07901801 weekly only during the first cycle for dose levels 1 and 2, and then decrease to every 
14 days for the duration of participant participation. Dose level 3 will be biweekly regimen 
from the start.
3.7.2 Pegylated Liposomal Doxorubicin
Doxorubicin is considered a standard of care in the intended patient population and will be 
used in accordance with the approved PLD package insert.
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3.8 Benefit-Risk Assessment
PLD is known to have clinical benefit in patients with platinum-resistant ovarian cancer and 
other single agent chemotherapeutic agents, including paclitaxel, may be used in the same 
setting of patients who have progressed on and are not resistant to platinum-based 
chemotherapy and who have received bevacizumab (or were intolerant of or not able to receive 
it) in an earlier setting and are not eligible for it in the platinum-resistant setting. However, 
with a response rate of less than 20%, a PFS of less than six months and median overall 
survival on the order of one year5,37-41 with any of the single agent chemotherapy regimens, 
there is a significant need for improvement. It is hypothesized that blockade of CD47-mediated 
immune evasion and concomitant activation of phagocytosis with PF-07901801 will be 
clinically beneficial in patients with ovarian cancer in which CD47 is expressed and 
macrophage scores are increased. In addition, preclinical data demonstrating synergy between 
doxorubicin, the parent molecule of PLD, and anti-CD47 antibodies, further suggesting that 
administration of PF-07901801 will enhance the disease control provided by the doxorubicin 
chemotherapy component of PLD in patients with platinum-resistant ovarian cancer. 
3.8.1 Expected Risks of PF-07901801 
In clinical trial TTI-622-01/C4971001, a multicenter, open-label, Phase 1a/1b study in 
participants with advanced hematologic malignancies, including lymphoma, leukemia and 
multiple myeloma, and reflecting a data cut-off of 12 April 2021, PF-07901801 has been 
administered at doses up to 18 mg/kg by weekly intravenous infusion. PF-07901801 has been 
safe and well-tolerated. The most frequent treatment-related adverse events of any grade 
occurring in more than 5% of participants were thrombocytopenia, neutropenia, anemia, 
fatigue and nausea. 
Grade ≥3 treatment-related adverse events were neutropenia, occurring in 4 participants (9%), 
thrombocytopenia, occurring in 2 participants (5%) and anemia (1 participant, 2%). Reflecting 
these observations, the safety monitoring schedule of this protocol includes routine hematology 
assessment. 
3.8.2 Expected Benefits of PF-07901801
In the Phase 1 dose escalation component of Study TTI-622-01/C4971001 in which PF-
07901801 is administered weekly, PF-07901801 has demonstrated single agent clinical activity 
in some of the 43 participants with advanced relapsed/refractory lymphoma. To date, a 33% 
ORR has been observed among response-evaluable participants enrolled across doses ranging 
from 0.8 – 18 mg/kg, including two CRs. A third participant had complete resolution of target 
lesions but was designated only PR on the basis of a residual PET imaging signal. There 
appears to be a fast onset of response, with responses noted by Week 8 of treatment in this 
participant population despite participant s having received numerous prior treatment 
regimens, as many as 10 prior regimens in a patient with DLBCL who achieved PR at Week 8 
and continues on treatment without progression. 
Thus, it is anticipated that PF-07901801 may offer disease control to patients with ovarian 
cancer who will have received prior treatment in the platinum-sensitive setting. Additionally, 
preclinical data suggesting synergy with a range of CD47-targeting molecules and doxorubicin 
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offers hope that the combination will provide a safe and effective treatment option for patients 
with platinum-resistant recurrent epithelial ovarian cancer.
More detailed information about the known and expected risks and adverse events of PF-
07901801 may be found in the PF-07901801 Investigator Brochure, which is the SRSD for this 
study.
4 STUDY OBJECTIVES AND ENDPOINTS
4.1 Primary Objectives
•
Evaluate DLTs, safety and tolerability of escalating dose levels of PF-07901801 
when administered in combination with 40 mg/m2 PLD in 28-day cycles and 
establish the MTD and RP2D combination regimen (Phase 1 portion of study)
•
Assess preliminary evidence of anti-tumor activity of PF-07901801 in combination 
with 40 mg/m2 PLD (Phase 2 portion of study)
4.2 Primary Endpoints 
•
DLTs during the DLT observation period (28 days following C1D1)Objective 
response (CR, PR) as defined by RECIST v1.1 criteria
4.3 Secondary Objectives
•
Further assess the overall safety profile of PF-07901801 administered in 
combination with 40 mg/m2 PLD
•
Assess additional efficacy outcomes 
4.4 Secondary Endpoints 
4.5 Exploratory Objectives
•
Assess effect of treatment with PF-07901801 in combination with PLD on CA-125 
levels
•
Characterize the PF-07901801 concentration in serum when administered in 
combination with PLD
•
Characterize the PLD concentration in plasma when administered in combination 
with PF-07901801
•
Assess DDI potential between PF-07901801 and PLD
•
Overall safety profile as assessed by the type, frequency, severity, timing and causal 
relationship of any adverse events, changes in vital signs, ECG, serum chemistry or 
other laboratory assessment, treatment delays or discontinuations
•
PFS, OS, disease control (DC [CR or PR or SD]), and DOR
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•
Evaluate development of antibodies directed against PF-07901801 
•
Explore possible relationships between PF-07901801 exposure and clinical 
outcome, safety and pharmacodynamics observations. 
•
Understand the relationship between the therapeutic intervention(s) being studied 
and the biology of the participant’s disease.
4.6 Exploratory Endpoints
•
Evaluate CA-125 levels in serial blood samples
•
Measurements of biomarkers/pharmacodynamics, which may consist of DNA, 
RNA, protein or defined cell types, resulting from analyses of peripheral blood 
and/or tumor tissue biospecimen obtained at baseline, on treatment and/or at end of 
study.
•
Immunogenicity: Incidence and titers of ADA and neutralizing antibodies against 
PF-07901801
•
PF-07901801 PK: Single and multiple Dose Cmax, 
, and clearance.
•
PLD PK: Single and multiple dose Cmax and Ctrough.
5 INVESTIGATIONAL PLAN
5.1 Overall Study Design
Pegylated liposomal doxorubicin (PLD) is a standard treatment option for patients with 
platinum-resistant recurrent epithelial ovarian cancer who are not candidates for chemotherapy 
in combination with bevacizumab. However, despite being considered a standard treatment 
option, the clinical benefit of chemotherapy for this patient population is small. The goal of 
this clinical trial is to improve upon the activity of PLD in a safe manner to provide a more 
effective therapeutic option for this group of patients. 
TTI-622-02/C4971002 is a multi-center, open-label study designed to evaluate PF-07901801 
administered in combination with PLD in participants with platinum-resistant recurrent 
epithelial ovarian cancer, including ovarian, peritoneal and fallopian tube malignancy, and for 
whom PLD is a reasonable treatment option. The first portion of the study will evaluate the 
safety of increasing dose levels of PF-07901801 in combination with PLD at 40 mg/m2 in 
participants with platinum-resistant EOC, including ovarian, peritoneal and fallopian tube 
malignancy, and establish a combination regimen for further evaluation in a dose expansion 
cohort. The study will consist of a 28-day screening period, a treatment period in which 
participants will receive PF-07901801 in combination with PLD in 28-day cycles until 
documentation of objective disease progression or development of unacceptable toxicity, and a 
long-term follow-up period to assess overall survival. 
Key inclusion criteria are ECOG performance status 0-1, platinum-resistant recurrent epithelial 
ovarian cancer, defined as disease progression ≤6 months after the most recent platinum-based 
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treatment regimen or participants who were no longer able to receive or declined treatment 
with platinum-based chemotherapy, no more than four prior treatment regimens for platinum-
resistant disease, measurable disease by RECIST v1.1, absence of bowel obstruction history, 
and adequate cardiac and end organ function. Participants with exposure to PLD while 
platinum-resistant or in the treatment regimen immediately prior to enrollment in this study, 
will not be eligible for treatment under this protocol; however, earlier exposure to PLD, 
including while platinum-sensitive, or for an indication other than recurrent platinum-resistant 
EOC, eg, breast cancer, will be allowed for participants in the Phase 1 dose escalation portion 
of the study. In the Phase 2, dose expansion portion of the study, depending on clinical benefit 
during Phase 1, earlier exposure to PLD, including while platinum-sensitive, may be allowed if 
agreed upon by the investigators and Pfizer. Prior treatment with doxorubicin or other 
anthracyclines’ equivalents at total cumulative doses must not be greater than 320 mg/m2 for 
doxorubicin, and calculated using doxorubicin equivalent doses: 1 mg doxorubicin= 1 mg 
pegylated liposomal doxorubicin (PLD)= 1.8 mg epirubicin= 0.3 mg mitoxantrone= 0.25 mg 
idarubicin.
In the Phase 1 dose escalation portion of the study, the primary objectives are assessment of 
DLTs, safety and tolerability of escalating dose levels of PF-07901801 in combination with 
PLD at the standard dose of 40 mg/m2 and establish the MTD and RP2D. Up to approximately 
18 participants are planned to be enrolled in this portion of the study to evaluate three dose 
levels of PF-07901801: 12 mg/kg (Dose Level 1), 24 mg/kg (Dose Level 2) and 48 mg/kg 
(Dose Level 3). In Cycle 1 for dose levels 1 and 2, PF-07901801 will be administered on Day 
1, Day 8, Day 15 and Day 22 in combination with PLD on Day 1 of 28-day cycle. Beginning 
with Cycle 2 at dose levels 1 and 2, PF-07901801 will be administered on Day 1 and Day 15 in 
combination with PLD on Day 1 of 28-day cycles. The enhanced dosing in Cycle 1 represents 
a loading cycle and is intended to allow PF-07901801 levels to more quickly reach steady 
state. For dose level 3, PF-07901801 will be administered on Day 1 and Day 15 in combination 
with PLD on Day 1 of 28-day cycles. Loading doses (Day 8 and Day 22) may be considered 
for Cycle 1 at the 48 mg/kg dose level if found to be safe and offer clinical benefit for 
participants. If Cycle 1 loading doses are implemented, all dosing and lab draw schedules for 
the 48 mg/kg dose will follow the schedules for dose levels 12 mg/kg and 24 mg/kg.
One dose level combination will be selected for further evaluation in the Phase 2 expansion 
portion of the study. The primary objective of the Phase 2 expansion portion of the study is 
investigation of clinical activity of the PLD and PF-07901801 combination; clinical activity 
will be assessed using the overall response by RECIST v1.1 as the primary efficacy endpoint.
Secondary objectives include further evaluation of the safety of the combination and 
assessment of other indications of disease control, including progression-free survival, overall 
survival, duration of response, and disease control (CR, PR, or SD ≥ 12 weeks) as defined by 
RECIST v1.1 criteria. 
Exploratory objectives include, evaluation of CA-125 levels, characterization of PF-07901801 
and PLD pharmacokinetics when co-administered, evaluation of development of antibodies 
directed against PF-07901801; exploration of possible relationships between PF-07901801 
exposure and clinical outcome, safety and pharmacodynamics observations, and to understand 
the relationship between the therapeutic intervention(s) being studied and the biology of the 
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participant’s disease. Exploratory endpoints include but are not limited to PK and 
immunogenicity of PF-07901801, PK of PLD, CA-125 levels, measurements of 
biomarkers/pharmacodynamics, which may consist of DNA, RNA, protein or defined cell 
types, resulting from analyses of peripheral blood and/or tumor tissue biospecimen obtained at 
baseline, on treatment and/or at end of study, as well as the single and multiple dose 
pharmacokinetics of PF-07901801. 
PLD will be administered at 40 mg/m2 on Day 1 of each 28-day cycle.
PF-07901801 will be administered by intravenous infusion; the duration of infusion is 
dependent on dose level with dose levels less than or equal to 33 mg/kg infused over 60 min 
and doses greater than 33 mg/kg infused over 90 minutes and will have doses equal to or less 
than 2500 mg in 250 mL and doses 2501 mg or more in 500 mL or neat drug if the drug 
volume is over 500 mL. Medications to treat infusion-related reactions and CPR equipment 
must be available for immediate use prior to initiation of PLD infusion.
The dose-limiting toxicity evaluation period will consist of the 28-day Cycle 1 or until 
participants experience a DLT in Cycle 1. Participants will be considered DLT evaluable if 
they receive PLD on Day 1 and at least two infusions of PF-07901801 in the 28-day Cycle 1. A 
participant who withdraws from the study during Cycle 1 in the absence of DLT evaluable (ie, 
not receiving PLD and at least two doses of PF-07901801) will be replaced If a dose-limiting 
toxicity as defined in Section 5.4 is encountered in one participant in the initial three 
participants in a dose cohort, three additional participants will be enrolled in accordance with 
the standard 3+3 study design. The maximum tolerated dose (MTD) for this study will be 
defined as the highest PF-07901801 dose level at which <33% of participants within a dose 
cohort experience dose-limiting toxicity when administered in combination with PLD at 40 
mg/m2. While three pre-defined PF-07901801 dose levels are anticipated, intermediate dose 
levels may be studied to more closely characterize the safety profile of PF-07901801 in 
combination with PLD.
After three to six participants in a dose cohort complete the 28-day dose-limiting toxicity 
assessment period, the incidence of dose-limiting toxicity, treatment-related safety 
observations and other available data, such as pharmacokinetic data, will be reviewed by the 
medical monitor, sponsor and investigators. If no participant in a three-participant cohort or no 
more than one participant in a six-participant dose cohort experiences treatment-related 
dose-limiting toxicity, the dose level will be deemed safe and dose escalation may proceed 
unless there are other unsuspected but concerning safety observations that suggest either an 
expansion of the current dose level or implementation of an intermediate dose level.
Objective disease assessments will be performed after every 8 (±1) weeks through week 48, or 
until participant has been on study for one year, and every 12 (±2) weeks thereafter.
Participants who withdraw from the study without objective evidence of disease progression 
will be followed until documentation of disease progression or initiation of another treatment. 
All participants will be followed in the Long-Term Follow-Up period for survival.
5.2 Doses and Schedule of Administration of Investigational Agents
PLD will be administered on Day 1 of 28-day cycles.
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In Cycle 1 for dose levels 1 (12 mg/kg) and 2 (24 mg/kg), PF-07901801 will be administered 
on Day 1, Day 8, Day 15 and Day 22 of a 28-day cycle. Beginning with Cycle 2, PF-07901801 
will be administered on Day 1 and Day 15 only of each 28-day cycle.
For dose level 3 (48 mg/kg) PF-07901801 will be administered on Day 1 and 15 of a 28-day 
cycle starting from Cycle 1. Loading doses (Day 8 and Day 22) may be considered for Cycle 1 
at the 48 mg/kg dose level if found to be safe and offer clinical benefit for participants. If 
Cycle 1 loading doses are implemented, all dosing and lab draw schedules for the 48 mg/kg 
dose will follow the schedules for dose levels 12 mg/kg and 24 mg/kg.
The following rules apply during dose escalation:
•
Starting dose at dose level 1 is 12 mg/kg.
•
At least 3 participants will be enrolled at each dose level. When all participants 
at a dose level complete DLT assessments, the study will escalate to the next 
dose level and another 3 participants will be recruited in this order until 
MTD/RP2D.
•
If agreed upon by the investigators and Pfizer (eg, based on safety, incidence of 
DTL, PK and dose-exposure data from prior and current cohorts) that increasing 
the dose further may not yield additional benefit, the dose may stay at the 
current dose level, be de-escalated to any dose, or no future escalation may be 
made, even if the dose escalation rule indicates to escalate.
•
The need for dose escalation to a specific dose beyond 48 mg/kg or de-
escalation to an intermediate dose level will be evaluated jointly by 
investigators and Pfizer based on cumulative clinical safety, PK, and 
preliminary efficacy data.
Table 11.
Participants Dose-Grouping, Dose Escalation Plan
Cohort #/Dose Level
Dose of PF-07901801 
(Intravenous)
Dose of PLD (Intravenous)
1
12 mg/kg
40 mg/m2
2
24 mg/kg
40 mg/m2
3
48 mg/kg
40 mg/m2
•
Participants will be considered DLT evaluable if they receive PLD on Day 1 and at least two infusions of PF-
07901801 in the 28-day Cycle 1
•
A participant who withdraws from the study during Cycle 1 in the absence of DLT evaluable (ie, not receiving 
PLD and at least two doses of PF-07901801) will be replaced
•
Participants who complete the DLT assessment window will be allowed to 
continue treatment until disease progression, intolerable toxicity, withdrawal of 
consent, lost to follow-up, end of study, or death, whichever comes first.
•
Participants with an early observation of disease progression, but without 
deterioration in clinical conditions or unacceptable toxicitywill be allowed to 
continue treatment until disease progression is verified by repeated disease 
assessment at least 4-weeks later.
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A participant who completes at least four cycles of treatment with PF-07901801 in 
combination with PLD and requires discontinuation of PLD due to PLD-related toxicity and 
who is receiving disease control may continue on study receiving PF-07901801 monotherapy 
beginning with the next cycle provided the participant has not experienced disease progression 
and PF-07901801 re-treatment guidelines as described in Section 9.1.2 are met. The 
investigator may consult with the medical monitor on a participant -by-participant basis in the 
event that early evidence of doxorubicin-related toxicity arises. 
On Day 1 of each cycle, PLD will precede administration of PF-07901801. An observation 
period between completion of PLD infusion and initiation of PF-07901801 infusion is not 
mandated.
5.2.1 PLD
Pegylated liposomal doxorubicin will be administered intravenously at a dose of 40 mg/m2 on 
Day 1 of each 28-day cycle. Doses up to 90 mg must be diluted in 250 mL of 5% Dextrose 
Injection, USP for administration to the participant; doses exceeding 90 mg will be diluted in 
500 mL of 5% Dextrose Injection, USP for administration to the participant. The initial 
infusion rate should be 1 mg/min to minimize the risk of infusion reactions. If no infusion-
related adverse reactions are observed, the rate of infusion can be increased to complete 
administration of the drug over one hour in accordance with institutional guidelines. 
The dose of PLD should be calculated at the beginning of each cycle. 
5.2.2 PF-07901801 
PF-07901801 will be administered by intravenous infusion on Day 1, Day 8, Day 15 and Day 
22 of the 28-day Cycle 1and on Day 1 and Day 15 of subsequent 28-day cycles (i.e., Cycle 2 
onward) for dose levels 1 and 2. For dose level 3, PF-07901801 will be administered by 
intravenous infusion on Day 1 and 15 of a 28-day cycle starting from Cycle 1.
The dose of PF-07901801 will be based upon the dose level cohort to which the participant is 
assigned; the duration of infusion is dependent on dose level: dose levels less than or equal to 
33 mg/kg infused over 60 min and doses greater than 33 mg/kg infused over 90 minutes and 
will have doses equal to or less than 2500 mg in 250 mL and doses 2501 mg or more in 500 
mL or neat drug if the drug volume is over 500 mL. At the investigator’s discretion, the 
duration of infusion can be lengthened but not abbreviated. Preparation instructions can be 
found in the IPM.
In any cycle in which PLD and PF-07901801 are administered on the same day, PLD treatment 
will precede administration of PF-07901801. A delay before initiation of PF-07901801 (TTI-
622) is not mandated.
For the purposes of safety decisions that guide cohort expansion and considerations of PF-
07901801 dose adjustment, the safety period will consist of the 28-day Cycle 1. 
A participant who completes at least four cycles of PF-07901801 in combination with PLD and 
experiences PLD-mediated toxicity that requires its discontinuation may revert to PF-
07901801 monotherapy with the next cycle provided the participant has not experienced 
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disease progression and PF-07901801 re-treatment guidelines as described in Section 9.1.2 are 
met.
Preparation of the PF-07901801 dose is based on body weight in kg and should be calculated at
the beginning of each cycle and may be used throughout the cycle unless a participant 
experiences a >10% variation in weight within a cycle. 
As described previously and presented again in Table 12 below, three dose levels of PF-
07901801 are planned to be evaluated in combination with fixed-dose PLD in a 3+3 study 
design in the dose escalation portion of the study. After review of emerging safety and other 
data from these dose levels, alternate PF-07901801 dose levels may be evaluated to more fully 
understand safety or pharmacodynamics of PF-07901801 in combination with PLD, to more 
fully identify dose-limiting toxicities, to more clearly define the maximum tolerated dose, 
and/or to optimize selection of the most appropriate dose(s) for evaluation in the expansion 
cohorts.
Table 12.
PF-07901801 Dose Levels Planned for Evaluation in Combination with 
PLD
Dose Level
PF-07901801 Dose
1
12 mg/kg
2
24 mg/kg
3
48 mg/kg
If Dose Level 1, 12 mg/kg, is found to be intolerable, a lower dose level may be evaluated. If Dose Levels 2 or 3 are not 
tolerated, intermediate dose levels may be evaluated.
5.3 Criteria for Treatment Discontinuation
Participants may withdraw voluntarily from participation in the study or from study treatment 
at any time and for any reason. A participant ’s participation in the study may terminate at 
his/her/their request or on the basis of the investigator’s clinical judgment. The reason for 
participant withdrawal will be documented in the source data and noted on the electronic case 
report form (eCRF).
At a minimum, all participants who discontinue study treatment, including those who refuse to 
return for a final visit, will be contacted for safety evaluations at the 30-Day Safety Follow-Up 
Visit.
If such withdrawal occurs, or if the participant fails to return for visits, the investigator must 
determine the primary reason for a participant’s withdrawal from the study and record the 
information on the eCRF. If the reason for withdrawal is an adverse event, monitoring should 
continue until the outcome is evident. The specific event or test result(s) must be recorded in 
the eCRF. At the discretion of the sponsor, participants may also be removed from the study.
It should be clearly documented in the source data whether participants withdrew consent for 
participation in the study, including study treatment and participation in the long-term 
follow-up phase or if participants withdrew from study treatment but will continue further 
participation in the long-term follow-up portion of the study.
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Treatment may be continued until one of the following criteria applies:
•
An unacceptable adverse event or safety observation, such as a persistent moderate
toxicity that is intolerable to the participant, that is in the opinion of the investigator 
clearly attributed to PF-07901801.
•
An unacceptable adverse event or safety observation, such as a persistent moderate 
toxicity that is intolerable to the participant, that is in the opinion of the investigator 
clearly attributed to PLD and the participant has received fewer than four cycles of 
PLD. A participant who has completed four cycles of PLD treatment and experiences 
an adverse event that requires discontinuation of PLD may continue on study receiving 
PF-07901801 monotherapy after discussion with the sponsor medical monitor. 
•
Any event which would cause PF-07901801 or PLD to be modified by more than two 
dose reductions or to be held for more than 42 days from the last administered dose and 
is not attributable to a particular agent of the combination regimen; exception is made 
for participants who are receiving meaningful disease control and the investigator feels, 
with sponsor medical monitor concurrence, that continued treatment is in the best 
interest of the participant.
•
Any treatment-related adverse event that is deemed life-threatening, regardless of 
grade. For Grade 4 adverse events, discontinuation of PF-07901801 should be 
considered. If it is in the participant’s best interest to continue PF-07901801 per 
investigator assessment, withhold dose until resolved to ≤Grade 1 or baseline, then 
reduce by 1 dose level. If the participant is receiving disease control and the 
investigator judges that continued treatment may be in the participants best interest, PF-
07901801 treatment may be resumed when the adverse event resolves to a level that 
meets re-treatment criteria. In consultation with the sponsor medical monitor, the dose 
level may be resumed; exception is made for participants in whom the life-threatening 
adverse event is attributed to PLD and the participant has received at least four cycles 
of PLD treatment and the investigator feels, with sponsor medical monitor concurrence, 
that continuation with PF-07901801 monotherapy would be reasonable. 
•
Documentation of objective (radiographic) disease progression; for participants with 
asymptomatic progression and in the absence of unacceptable toxicity, the participant 
should continue treatment and a confirmation scan should be conducted at least four 
weeks later to document objective progression prior to removing participant from study 
treatment. A participant should not be removed from study on the basis of change in 
CA-125 level in the absence of objective or asymptomatic progression.
•
The mechanism of immunotherapy is mechanistically distinct from other 
types of therapy.  The patterns of response and progression to 
immunotherapeutic agents, such as TTI-622, often differ temporally, 
qualitatively and quantitatively from those observed with cytotoxic and 
targeted agents.  The goal of immunotherapy is to overcome 
immunosuppression induced by a tumor and its microenvironment, thereby 
allowing the immune system to develop or activate an immune response that 
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targets and kills cancer cells.  Some patients have experienced pseudo-
progression or immune-mediated inflammation, in which areas of disease 
showed an initial surge followed by shrinkage that led to development of 
immune-related disease response criteria that supports continued treatment 
beyond progression in patients whose clinical conditions have not worsened 
and who have not experienced severe toxicities.  Recognizing that 
immunotherapy represents a paradigm shift in oncology treatment, patients 
with an early observation of disease progression but without deterioration in 
clinical conditions or unacceptable toxicity and who consent should 
continue treatment until disease progression is verified by a repeated disease 
assessment at least four weeks later.
•
Unacceptable toxicity which in the opinion of the investigator cannot be attributed to a 
specific study agent.
•
An intercurrent illness or change in the participant’s condition that renders the 
participant unsuitable for further treatment in the opinion of the investigator; exception 
may be made for participants in whom the intercurrent illness or change in condition is 
thought to render the participant ineligible for continued treatment with PLD and the 
participant has received at least four cycles of PLD and the investigator feels, with 
medical monitor concurrence, that continuation with PF-07901801 monotherapy would 
be reasonable and the participant meets criteria for PF-07901801 re-treatment
•
Significant noncompliance with study protocol.
•
Withdrawal of consent for participation in the treatment portion of the study 
(participant may participate in Long-Term Follow-Up assessment of survival and 
disease status [if withdrawn prior to documentation of objective disease progression] if 
consent for Long-Term Follow-Up assessment is not withdrawn).
•
Participant is lost to follow-up.
•
Termination of the study by the sponsor.
At the investigator’s discretion and in agreement with the  sponsor, treatment after objective 
disease progression may continue for a participant who is clinically stable and receiving 
meaningful disease control and the investigator feels it is in the participant’s best interest to 
continue treatment. The reason for continuing treatment must be thoroughly discussed, agreed 
with the sponsor medical monitor, and clearly documented in the study files.
5.4 Dose-Limiting Toxicity Criteria for the Dose Escalation Portion of the Study
Dose-limiting toxicity is defined as any of the following treatment-emergent adverse events 
that occurs during the 28-day Cycle 1 and are judged by the investigator as related to PF-
07901801 or the combination of PF-07901801 and PLD. Adverse events that are in the opinion 
of the investigator attributable exclusively to intravenous infusion of PLD or any PLD 
prophylaxis medication will not be considered a dose-limiting toxicity.
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6 STUDY POPULATION
6.1 Number of Participants
Up to approximately 50 participants are anticipated to participate in the study, with up to 18 
DLT-evaluable in the Phase 1 dose escalation portion of the study and up to  30 treated in the 
Phase 2 dose expansion portion.
6.2 Inclusion Criteria 
Participant must meet all the following criteria to be enrolled in the study:
General
1. Written informed consent obtained prior to performing any study-specific 
procedure, including screening procedures
2. Females ≥ 18 years of age
3. ECOG Performance Status 0 or 1
Disease Characteristics
4. Histologically-confirmed epithelial ovarian cancer (EOC), fallopian tube carcinoma 
(FTC) or primary peritoneal carcinomas (PPC). 
Eligible histological subtypes are:
•
Adenocarcinoma NOS
•
Clear cell adenocarcinoma
•
Endometrioid adenocarcinoma
•
Malignant Brenner’s tumor
•
Mixed epithelial carcinoma
•
Mucinous adenocarcinoma
•
Serous adenocarcinoma
•
Transitional cell carcinoma
•
Undifferentiated carcinoma
5. Platinum-resistant recurrent disease, defined as disease progression ≤6 months after 
the most recent platinum-based treatment regimen (date calculated from the last 
administered dose of platinum) or the participant is no longer able to receive or 
declined treatment with platinum-based chemotherapy
•
Includes standard of care therapies, including platinum-based therapies, 
PARP inhibitors (Poly ADP Ribose Polymerase) or bevacizumab in the 
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platinum-sensitive setting or intolerability to such therapies or participant
refusal
6. Measurable disease per RECIST v1.1; target lesions must not be chosen from a 
previously-irradiated field unless there has been radiographically and/or 
pathologically documented tumor progression in that lesion prior to enrollment.
Organ Function
Adequate organ and hematologic function as defined below:
7. Serum AST and ALT ≤3 x upper limit of normal (ULN); ≤5 x ULN in the presence 
of liver metastasis
8. Serum bilirubin (total) ≤1.5 x ULN (≤2 x ULN if hyperbilirubinemia is due to 
Gilbert’s syndrome)
9. Serum creatinine ≤1.5 x ULN OR creatinine clearance/estimated glomerular 
filtration rate (eGFR) ≥40 mL/min/1.73 m2 if serum creatinine is >1.5 x ULN
10. Hemoglobin ≥9 g/dL; packed red blood cell transfusions are not allowed in the two 
weeks preceding screening evaluation
11. ANC ≥1.5 × 109/L
12. Platelet count ≥100 × 109/L
13. Left ventricular ejection fraction (LVEF) determined by echocardiogram or 
multigated acquisition scan >50% at screening
Previous Therapy
14. Unlimited lines of therapies in the platinum-sensitive setting are allowed. Once a 
participant becomes platinum-resistant no more than four prior treatment regimens 
for platinum-resistant disease are allowed 
•
If bevacizumab was not used as a treatment option during the platinum-sensitive 
setting, then bevacizumab in combination with paclitaxel must be considered as 
the first-line platinum-resistant treatment option except in the case of 
intolerability to such therapies or participant refusal.
15. Participants with exposure to PLD while platinum-resistant or in the treatment 
regimen immediately prior to enrollment in this study, will not be eligible for 
treatment under this protocol; however, earlier exposure to PLD, including while 
platinum-sensitive, or for an indication other than recurrent platinum-resistant EOC, 
eg, breast cancer, will be allowed for participants in the Phase 1 dose escalation 
portion of the study. In the Phase 2, dose expansion portion of the study, depending 
on clinical benefit during Phase 1, earlier exposure to PLD, including while 
platinum-sensitive, may be allowed if agreed upon by the investigators and Pfizer.
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Prior treatment with doxorubicin or other anthracyclines’ equivalents at total 
cumulative doses must not be greater than 320 mg/m2 for doxorubicin, and 
calculated using doxorubicin equivalent doses: 1 mg doxorubicin= 1 mg pegylated 
liposomal doxorubicin (PLD)= 1.8 mg epirubicin= 0.3 mg mitoxantrone= 0.25 mg 
idarubicin
16. All adverse events from prior treatment must be NCI CTCAE v5 Grade ≤ 1, except 
alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline
Contraception
17. Female participants of childbearing potential (CBP) who participate in the study 
should be counseled on the need to practice adequate birth control and on the 
importance of avoiding pregnancy during study participation. Please refer to 
Section 6.6 and Appendix C for detailed reproductive criteria
18. Female participants of childbearing potential must have a serum pregnancy test at 
screening. Following screening, pregnancy tests may be urine or serum tests, and 
must have a sensitivity of at least 25 mIU/mL. A negative pregnancy test result at 
screening and at baseline is required before the first study drug administration
6.3 Exclusion Criteria
1. Platinum-refractory disease, defined as progression on or within 3 months of 
completing primary first-line platinum-based treatment
2. Malignant mixed Mullerian tumors
3. Ovarian tumors with low malignant potential (i.e., borderline tumors), low grade 
serous ovarian cancer
Cardiovascular System
4. History of acute coronary syndromes, including myocardial infarction, coronary 
artery bypass graft, unstable angina, coronary angioplasty or stenting within 24 
weeks prior to first administration of study drug
5. History of or current Class II, III or IV heart failure as defined by the New York 
Heart Association (NYHA) functional classification system or symptomatic or 
poorly controlled cardiac arrhythmia 
6. Uncontrolled or poorly-controlled hypertension (defined as systolic blood pressure 
>160 mm Hg and/or diastolic > 100 mg Hg) for more than four weeks despite 
optimal medical management
7. Peripheral vascular disease > Grade 3 (i.e., symptomatic and interfering with 
activities of daily living requiring repair or revision)
General and Infectious Disease
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8. Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and 
sponsor delegate employees directly involved in the conduct of the study and their 
family members
9. Any comorbidity or concomitant medication or other medical or psychiatric
condition including recent (within the past year) or active suicidal ideation/behavior 
or laboratory abnormality that may increase the risk of study participation that in 
the opinion of the investigator and/or sponsor medical monitor renders the
participant unsuitable for participation in the trial or unlikely to fully comply with 
study procedures, restrictions and/or requirements that are considered relevant for 
evaluation of the efficacy or safety of the trial drug
10. Uncontrolled intercurrent illness, including active or chronic uncontrolled bacterial, 
fungal, or viral infection, including (but not limited to) HBV, HCV, and known 
HIV or AIDS related illness requiring systemic therapy or oral or systemic 
antibiotics within 14 days prior to study start. Participants with HIV with an 
undetectable viral load and a CD4 count ≥400 μL are eligible
11. History of non-viral hepatitis or cirrhosis, alcohol abuse or active tuberculosis
12. Administration of live attenuated vaccines within 28 days prior to start of treatment 
or anticipated need for vaccination with live attenuated vaccine during the study
13. COVID-19/SARS-CoV-2: While SARS-CoV-2 testing is not mandated for entry 
into this study, testing should follow local clinical practice standards. If a 
participant has a positive test result for SARS-CoV-2 infection, is known to have 
asymptomatic infection or is suspected of having SARS-CoV-2, the participant is 
excluded until a negative antigen test and resolution of symptoms if applicable
14. Major surgery within 28 days of scheduled Cycle 1 Day 1 dosing or minor surgery 
within seven days prior to initiation of study treatment or elective or planned major 
surgery to be performed during the course of the clinical trial
CNS Disease Considerations
15. History or evidence of known CNS metastases or carcinomatous meningitis; 
participants with previously treated brain metastases may participate provided they 
are stable (without evidence of progression by imaging for at least four weeks prior 
to the first dose of trial treatment and any neurologic symptoms have returned to 
baseline), have no evidence of new or enlarging brain metastases, and are not using 
steroids for at least seven days prior to study treatment; this exception does not 
include carcinomatous meningitis which is excluded regardless of clinical stability
Coagulation Considerations
16. Significant bleeding disorders, vasculitis or a significant bleeding episode within 
three months prior to study entry. Ongoing prophylactic anticoagulation therapy at a 
stable dose for prevention of VTE (Venous Thromboembolism) are allowed. Note: 
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Participant on therapeutic anticoagulation must not be started on study before 
therapy is completed and prophylactic anticoagulation is established.
Immune System
17. History of severe hypersensitivity reactions to antibodies
18. Chronic systemic steroid therapy (>10 mg daily prednisone or equivalent) or any 
other form of immunosuppressive therapy within seven days prior to the first dose 
of study treatment; topical, inhaled, nasal and ophthalmic steroids are not 
prohibited; Intermittent prophylaxis per site institutional policy is not prohibited as 
long as it does not exceed chronic daily use of >10 mg prednisone or equivalent e.g. 
prophylactic use of steroids for Palmar Plantar Erythrodysesthesia (PPE) toxicity 
with PLD is allowed.
19. History of autoimmune disease that has required systemic treatment with disease-
modifying agents, corticosteroids, or immunosuppressive drugs unless in the 
opinion of the investigator the participant is in a complete and durable remission; 
physiologic replacement therapies, such as thyroxine, insulin, or physiologic 
corticosteroid replacement therapy for adrenal or pituitary insufficiency, is allowed
20. Prior organ transplantation including allogeneic or autologous stem cell 
transplantation
Oncology
21. Concurrent or previous other malignancy within two years of study entry with the 
exception of cured basal or squamous cell skin cancer, superficial bladder cancer, 
carcinoma in situ of the cervix, other non-invasive or indolent malignancy, 
surgically-excised malignancy that is considered cured
22. Concurrent enrollment in another therapeutic clinical study 
23. Prior treatment with anti-CD47 or anti-SIRPα therapy
6.4 Re-Screening
A participant who fails to qualify for the study based on laboratory tests may be considered for 
rescreening at the discretion of the investigator and after consultation with the sponsor medical 
monitor if it is considered that the participant status has changed and the participant  may now 
qualify for the study. Screening is limited to 2 attempts (initial screening and 1 rescreening 
attempt).
6.5 Waivers of Inclusion/Exclusion Criteria
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known 
as protocol waivers or exemptions, is not permitted.
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6.6 Participants of Reproductive Potential
The investigator or their designee, in consultation with the participant, will confirm that the 
participant is using an appropriate method of contraception for the individual participant and 
their partner(s) from the permitted list of contraception methods (see Appendix C) and will 
confirm that the participant has been instructed in its consistent and correct use. At time points 
indicated in the SoA (Table 28), the investigator or designee will inform the participant of the 
need to use highly effective contraception consistently and correctly and document the 
conversation and the participant’s affirmation in the participant’s chart. Participants need to 
affirm their consistent and correct use of the selected methods of contraception (refer to 
Appendix C), considering that their risk for pregnancy may have changed since the last visit. 
In addition, the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued and document the requirement to use an 
alternate protocol-specified method, including if the participant will no longer use abstinence 
as the selected contraception method, or if pregnancy is known or suspected in the participant 
or partner.
Pregnancy testing will be conducted prior to administration of IP and throughout study 
participation on every woman of childbearing potential. A woman who is found to be pregnant 
at the screening visit will be excluded from the study and considered to be a screen failure.
A serum pregnancy test is required at screening. Following screening, pregnancy tests may be 
urine or serum tests, and must have a sensitivity of at least 25 mIU/mL. Pregnancy tests will be 
performed in WOCBP at the times listed in the Schedule of Assessments (Table 28). Following 
a negative pregnancy test result at screening, appropriate contraception must be commenced 
and a second negative pregnancy test result will be required at the baseline visit prior to the 
participant receiving the study treatment. Pregnancy tests will also be done whenever one 
menstrual cycle is missed during the active treatment period (or when potential pregnancy is 
otherwise suspected) and at the end of the study. Pregnancy tests may also be repeated if 
requested by IRBs/ECs or if required by local regulations. If a urine test cannot be confirmed 
as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the 
participant must be excluded if the serum pregnancy result is positive.
Participants will be instructed to notify the investigator if pregnancy is discovered either during 
or within 45 days after the last dose of PF-07901801 or during and six months after the last 
dose of PLD in combination treatment (as per the full prescribing information in the USPI for 
PLD [DOXIL®]), which corresponds to the time needed to eliminate any reproductive safety 
risk of the study intervention(s). The investigator must report information to Pfizer Safety 
through Pfizer SAE Submission Assistant (PSSA) using the CT SAE Report Form and EDP 
Supplemental Form.
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7 ENROLLMENT PROCEDURE AND METHOD OF ASSIGNING SUBJECTS TO 
TREATMENT GROUPS 
7.1 Enrollment Procedure
At the time a prospective patient signs the informed consent form, a unique patient number will 
be assigned and the appropriate portion of a Registration/Enrollment form will be completed 
and sent to the sponsor or designee. Patients will be screened for eligibility according to the 
criteria outlined in Section 6. Once a patient is deemed eligible, the completed 
Registration/Enrollment form will be sent to the investigator or designee, at which time the PF-
07901801 dose level and cohort will be assigned. 
7.2 Method of Assigning Subjects to Treatment Groups 
The dose escalation portion of the study carries a traditional 3+3 design to evaluate three dose 
levels of PF-07901801 in combination with fixed-dose PLD (40 mg/m2). Standard guidelines 
for enrollment for the 3+3 design will be followed, with requirement that three participants 
complete the 28-day safety assessment period before the next dose cohort is open to enrollment 
and expansion to six participants in the case of a treatment-related dose-limiting toxicity. 
Only a single PF-07901801 dose level in combination with fixed-dose PLD (40 mg/m2) is 
planned for evaluation in the dose expansion portion of the study. During the dose expansion 
portion of the study, eligible participants will be enrolled into this cohort in chronological 
order of eligibility verification as they complete screening assessments. 
8 DESCRIPTION OF STUDY TREATMENT
8.1 PF-07901801 
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8.1.1 How Supplied
Sterile formulated PF-07901801 Drug Product is supplied at a concentration of 10 mg/mL in 
single-use 20 mL Type I borosilicate glass vials with butyl rubber stoppers and aluminum 
seals. The extractable volume is 14 mL PF-07901801 Drug Product.
8.1.2 Storage Conditions
PF-07901801 Drug Product  storage conditions and allowances at clinical sites based on 
evolving stability data is provided in the Pharmacy Manual. 
8.2 Pegylated Liposomal Doxorubicin
The active ingredient in doxoribucin hydrochloride liposome injection is doxorubicin 
hydrochloride that is encapsulated in liposomes for intravenous use. Doxorubicin 
hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each 
single-dose vial of doxorubicin hydrochloride liposome injection contains 20 mg 
(20 mg/10 mL in a 10 mL vial) or 50 mg (50 mg/25 mL in a 30 mL vial) doxorubicin 
hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and at 
a pH of 6.5. Unopened vials should be refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze.
8.3 Preparation and Administration of Study Treatments
All administration of study treatments should be performed in a setting with emergency 
medical facilities and staff who are trained to monitor for and respond to medical emergencies. 
8.3.1 PF-07901801
The required number of vials of PF-07901801 Drug Product, determined based on the dose 
level and participant’s body weight, will be prepared.
See the IP Manual for instructions on how to store and prepare the study intervention for 
administration. Study intervention should be prepared and dispensed by an appropriately 
qualified and experienced member of the study staff (eg, physician, nurse, physician’s 
assistant, nurse practitioner, pharmacy assistant/technician, or pharmacist) as allowed by local, 
state, and institutional guidance. A second staff member will verify the dispensing.
8.3.2 Pegylated Liposomal Doxorubicin
8.4 Pegylated liposomal doxorubicin will be administered per the approved package 
insert. The IP Manual should be referenced for additional information.Blinding of 
Treatment
This is an open-label study; study treatments will not be blinded.
8.5 Treatment Compliance
The study treatments will be administered by personnel at the study site to ensure compliance.
8.6 Study Drug Accountability 
Study personnel will maintain accurate records of study drug shipments, receipt and 
dispensing. The site is responsible for the return or destruction of PF-07901801 as required. 
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8.7 Concomitant Medications
Participants are allowed to continue medications that they are taking at baseline. Participants 
may also receive concomitant medications that are medically indicated for the treatment of 
symptoms and intercurrent illnesses. Medications to treat concomitant diseases, e.g., diabetes, 
hypertension, chronic obstructive pulmonary disease, are allowed. Prophylaxis for infusion-
related reactions is not mandated but the investigator at his/her/their discretion may provide 
prophylaxis medications to prevent development of infusion-related reactions prior to infusions 
of PF-07901801 or PLD; the participant may receive therapy for symptom control and/or to 
mitigate side effects of the study medication as clinically indicated, as well as best supportive 
care as per institutional guidelines. This may include, e.g., anti-emetics, anti-diarrheals, anti-
cholinergics, anti-spasmodics, anti-pyretics, anti-histamines, analgesics, antibiotics and other 
medications such as analgesics, electrolyte replacement, hydration, and/or blood product 
transfusions intended to treat symptoms. Other prescribed medications for non-neoplastic 
conditions are allowed, as well as vitamins and nutritional supplements (at doses per the 
Recommended Dietary Allowance or supplementing a known deficiency). The investigator 
should instruct the participant not to take any additional medications (including over-the-
counter products) during the study without prior consultation. 
All concomitant medications, including dose and reason for administration, will be recorded in 
the eCRF.
8.7.1 Concomitant Corticosteroids
Chronic use of steroid above a daily equivalent dose of 10 mg prednisone is not permitted on 
study; Intermittent prophylaxis per site institutional policy is not prohibited as long as it does 
not exceed chronic daily use of >10 mg prednisone or equivalent e.g. prophylactic use of 
steroids for Palmar Plantar Erythrodysesthesia (PPE) toxicity with PLD is allowed
8.7.2 Concomitant Hematopoietic Growth Factors and Blood Products
Participants must have adequate hematological function with no transfusion or colony 
stimulating factor or erythropoiesis-stimulating agent for at least 2 weeks prior to Cycle 1 
Day 1.
Primary prophylactic use of colony stimulating factors or erythropoiesis-stimulating agents or 
blood product transfusions are not permitted during the first 28 days of Phase 1 Cycle 1 (DLT 
evaluation period), unless indicated due to medical emergency.
Beginning with Cycle 2,myeloid growth factors are permitted for treatment-emergent Grade 3 
or Grade 4 neutropenia. Likewise, erythropoiesis-stimulating or megakaryopoiesis-stimulating 
agents may be used for treatment-emergent anemia or thrombocytopenia, respectively and , 
prophylactic use of G-CSF according to institutional standards is permitted. 
Transfusion thresholds for blood product support will be in accordance with institutional 
guidelines.
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8.7.3 Concomitant Anti-Coagulants
Ongoing prophylactic anticoagulation therapy at a stable dose (low molecular weight heparin, 
heparin, warfarin or dabigatran) for prevention of Cancer-Associated Venous Thromboembolic 
Disease, per local institutional guidelines is permitted. Note: Participants on therapeutic 
anticoagulation must not be started on study before therapy is completed and prophylactic 
anticoagulation is established.
8.7.4 Prohibited Medications and Potential Drug-Drug Interactions 
There are currently no drugs identified to have potential DDI concerns with PF-07901801.
Investigators should consult the USPI for PLD for information regarding medication that are
prohibited for concomitant use.
The Pfizer study team is to be notified of any prohibited medications taken during the study. 
After consulting with the sponsor, the investigator will make a judgment on the ongoing 
participation of any participant with prohibited medication use during the study.
a.
Participants must not receive live, attenuated vaccines (eg, FluMist®) within four 
weeks prior to first day of study treatment, at any time during the study, or through 90 
days after the last dose of PF-07901801. Inactivated vaccines are allowed. Influenza 
vaccination should be given during influenza season only (approximately October to 
March).
b. Doxorubicin, the active component of PLD, is a major substrate of cytochrome P450 
CYP3A4 and CYP2D6, and P-glycoprotein (P-gp). Clinically significant interactions 
have been reported with inhibitors of CYP3A4, CYP2D6, and/or P-gp (e.g., 
verapamil), resulting in increased concentration and clinical effect of doxorubicin. 
Inducers of CYP3A4 (e.g., phenobarbital, phenytoin, St. John’s Wort) and P-gp 
inducers may decrease the concentration of doxorubicin. While the Prescribing 
Information for PLD does not carry these statements, the investigator may consider 
whether concurrent use of inhibitors and inducers of CYP3A4, CYP2D6 or P-gp is 
warranted or should be avoided when PLD is being administered or may wish to 
employ alternate medications when possible. The investigator should consult with the 
sponsor medical monitor when considering use of one of these agents.
c.
Due to potential impact on metabolism of both PF-07901801 and PLD, THC/CBD and 
herbal products are prohibited while the participant is receiving treatment on study. 
The investigator may discuss this potential interaction with the sponsor medical 
monitor.
d. Chronic use of steroid above a daily equivalent dose of 10 mg prednisone is not 
permitted on study except in circumstances outlined in Section 8.7.1.
8.8 Treatment of Overdose
There are no known antidotes for overdoses of PF-07901801, PLD or doxorubicin, the active 
component of PLD. In the event of an overdose of PF-07901801 or PLD, discontinuation of 
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treatment may not have immediate therapeutic effect. In the event of a known or suspected 
overdose, the participant should be monitored with appropriate hematology and clinical 
chemistry and should receive supportive therapy, as necessary. 
The PLD Full Prescribing Information reports that overdosage with doxorubicin hydrochloride 
causes increased risk of severe mucosities, leukopenia and thrombocytopenia. Treatment of a 
severely myelosuppressed participant require hospitalization, anti-microbials, platelet 
transfusions and symptomatic treatment of mucositis. Use of hematopoietic growth factor 
(G-CSF, GM-CSF) may be considered. 
Doxorubicin hydrochloride liposome injection Prescribing Information carries a warning that 
myocardial damage, include left ventricular failure, can occur. Thus, dexrazoxane may be 
considered for cardioprotection in participants who have received an excess of doxorubicin. 
The Prescribing Information also carries a warning that serious, life-threatening, and fatal 
infusion-related reactions can occur but does not mandate prophylaxis for such reactions. At 
the discretion of the investigator and in accordance with institutional guidelines, the 
investigator may implement prophylaxis.
Decisions regarding dose interruptions or modifications for PF-07901801 and/or PLD in the 
case of a suspected overdose will be made by the investigator in consultation with the sponsor 
medical monitor based on the clinical evaluation of the participant.
Information regarding the quantity of the excess dose as well as the duration of the overdosing 
should be documented in the appropriate eCRF.
9 MONITORING AND MANAGEMENT OF EXPECTED OR POTENTIAL ADVERSE 
EVENTS
Participant safety will be monitored throughout the study and supportive measures consistent 
with optimal participant care according to institutional standards should be provided 
throughout the study. Emergency resuscitation equipment and medications should be readily 
available. Additional supportive measures should also be available and may include 
epinephrine, antihistamines, corticosteroids, IV fluids, vasopressors, oxygen, bronchodilators 
and acetaminophen.
Adverse events observed, mentioned or spontaneously reported by the participant will be 
documented. The investigator will be responsible for monitoring the safety of participants and 
for alerting the sponsor or its designee of any event that seems unusual, even events considered 
an unanticipated benefit to the participant. The investigator is responsible for appropriate 
medical care of participants during the study and for adverse events that are serious in nature, 
considered related or unrelated to the study intervention or that cause the participant to 
discontinue. Laboratory abnormalities and adverse events will be graded according to NCI 
CTCAE version 5.0. 
In the following section, guidelines are presented for management of adverse events attributed 
to PF-07901801 (Section 9.1) or PLD (Section 9.2) and management of adverse events when 
attribution to neither agent is possible in the opinion of the investigator (Section 9.3).
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9.1 Management of Adverse Events Associated with PF-07901801 
Except in the case of proteinuria, asymptomatic laboratory abnormalities should not result in 
dose interruptions, modifications, or discontinuation of study therapy unless determined by the 
investigator to be clinically significant or life-threatening.
9.1.1 PF-07901801 Treatment Interruptions
Treatment with PF-07901801 may be interrupted for up to 56 days for toxicity assessed as 
related to treatment with PF-07901801; treatment may be interrupted for up to 28 days for 
reasons unrelated to toxicity if the participant is receiving disease control and after discussion 
with the sponsor medical monitor. Treatment may be re-instated after discussion with the 
medical monitor. In general, if an interruption of more than 56 days is required due to adverse 
events, PF-07901801 will be permanently discontinued; however, if in the judgment of the 
investigator, the participant is likely to derive disease control from PF-07901801 after a hold of
more than 56 days, study drug may be re-started with the approval of the sponsor medical 
monitor. The infusion duration may be increased and/or other precautionary measures 
instituted after discussion with the sponsor medical monitor, but the PF-07901801 dose level 
does not require modification when administration is re-started. Longer interruptions may be 
acceptable on a participant -by- participant basis at the discretion of the investigator after 
discussion with the sponsor medical monitor.
9.1.2 PF-07901801 Re-Treatment Guidelines 
The parameters described in Table 14 should be met for re-treatment with PF-07901801 on any 
study day.
Table 14.
Requirements for Re-Treatment with PF-07901801
Parameter
Criterion
ANC
≥1.0 × 109/L
Platelet Count
≥75 × 109/L
Bilirubin
≤1.5 × ULN (≤2 x ULN if hyperbilirubinemia is due to Gilbert’s syndrome)
AST, ALT
≤3 × ULN (<5 × ULN if liver metastases)
Treatment-Related Adverse Event
NCI CTCAE Grade <2 or baseline level (except for alopecia)
9.1.3 PF-07901801 Dose Modification Guidelines
Table 15 describes modifications for the dose levels intended to be evaluated in the dose 
escalation portion of the study. 
Table 15.
PF-07901801 Dose Modifications
Dose Level
Dose Level -1
Dose Level -2
48 mg/kg 
32 mg/kg
24 mg/kg
24 mg/kg
18 mg/kg
12 mg/kg
12 mg/kg
8.0 mg/kg
4.0 mg/kg
While PF-07901801 has demonstrated clinical activity in Study TTI-622-01 at dose levels as 
low as 0.8 mg/kg, the agent has demonstrated a very promising safety profile suggesting that 
dose reductions may not be routinely required. Thus, the study does not prospectively envision 
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requirement for a dose level below 4.0 mg/kg but a lower dose level may be allowed after 
consultation with the sponsor medical monitor for a participant who is receiving disease 
control and remaining on treatment is, in the opinion of the investigator, a reasonable treatment 
option for the participant. 
9.1.4 Hematologic Adverse Events Related to PF-07901801 Administration
Blood counts will be monitored regularly as outlined in the Schedule of Assessments, Table 28
in Section 10, with additional testing obtained according to standard clinical practice. 
Management of hematologic adverse events associated with PF-07901801 administration is 
summarized in Table 16, Management of Hematologic Adverse Events Associated with PF-
07901801  Platelet transfusion is allowed to manage thrombocytopenia to prevent and 
minimize bleeding according to ASH and ASCO guidelines. Per these guidelines, the platelet 
count threshold for prophylactic platelet transfusion is <10,000 × 109/L. Investigators should 
consider the participant’s medical history, concomitant medications and concurrent conditions 
to provide support for thrombocytopenia. 
Table 16.
Management of Hematologic Adverse Events Associated with -PF-
07901801 Administration
Observation
Management Guidelines
Grade 3 thrombocytopenia
Grade 4 thrombocytopenia lasting ≤72 hours
•
Continue PF-07901801 at the same dose when the 
re-treatment criterion (≥75 x 109/L or baseline) is 
met
Grade 4 thrombocytopenia lasting >72 hours 
Platelets ≤ 10 × 109/L at any time
•
Delay PF-07901801 dosing until the re-treatment 
criterion (≥75 x 109/L or baseline) is met
•
Transfuse platelet prophylactically against bleeding 
when platelets ≤10 × 109/L per ASCO practice 
guideline, then resume PF-07901801:
o
At the same dose if dose delay was ≤1 week
o
One dose level reduction if dose delay was >1 
week
o
One dose level reduction if the event recurs
Grade ≥3 thrombocytopenia with clinical 
bleeding (more than easily-controlled 
epistaxis, mild gum bleeding or menses)
Delay PF-07901801 dosing until the re-treatment criterion 
(≥75 x 109/L or baseline) is met and then resume PF-
07901801 at a reduced dose (1 dose level reduction) 
Grade 4 neutropenia lasting >72 hours
•
Delay PF-07901801 dosing until the re-treatment 
criterion (ANC >1.0 × 109/L) is met, then resume 
PF-07901801: 
o
At the same dose if dose delay was ≤1 week
o
One dose level reduction if dose delay was >1 
week
o
One dose level reduction if the event recurs
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Table 16.
Management of Hematologic Adverse Events Associated with -PF-
07901801 Administration
Observation
Management Guidelines
Grade 3 febrile neutropenia lasting >72 
hours
Grade 3 neutropenia with clinical evidence 
of infection
Grade 4 febrile neutropenia
Delay PF-07901801 dosing until the re-treatment criterion 
(ANC > 1.0 × 109/L) is met, then resume PF-07901801 at 
one dose level reduction
Grade 3 anemia
•
Delay PF-07901801 dosing until resolution to 
Grade ≤ 1 or baseline, then resume PF-07901801 
treatment:
o
At the same dose if dose delay was ≤ 1 week
o
One dose level reduction if dose delay was >1 
week
o
One dose level reduction if the event recurs
Grade 4 anemia
•
For Grade 4 events, discontinuation of PF-07901801 
should be considered. If it is in the participant’s best 
interest to continue PF-07901801 per investigator 
assessment, withhold dose until resolved to ≤Grade 1 or 
baseline, then reduce by 1 dose level
9.1.5 Non-Hematologic Adverse Events Related to PF-07901801 Administration
PF-07901801 (TTI-622) dose adjustments based on the occurrence of non-hematologic 
treatment-related adverse events are described in Table 17.
Table 17.
Management of Non-Hematologic Adverse Events Associated with PF-
07901801 Administration
Observation
Management Guidelines
Grade ≥3 events with the following 
exceptions:
•
Nausea and/or vomiting lasting <72 
hours with supportive care
•
Fatigue lasting ≤72 hours
•
Laboratory abnormalities lasting 
<72 hours and 
judged by the investigator as not clinically 
significant 
•
For Grade 3 events, delay PF-07901801 dosing until the 
re-treatment criteria are met, then resume PF-07901801 
at one dose level reduction 
•
No dose reduction is required for the exceptions listed
•
For Grade 4 events, discontinuation of PF-07901801 
should be considered unless the adverse event was 
transient and/or asymptomatic and/or not clinically 
significant. If the investigator judges that continued 
treatment may be in the participant ’s best interest, PF-
07901801 treatment can be resumed when the adverse 
event resolves to a level that meets re-treatment criteria. 
In consultation with the medical monitor, the dose level 
may be reduced.
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9.1.6 Management of Other Adverse Events Related to PF-07901801 Administration
PF-07901801 dose adjustments based on the occurrence of other treatment-related adverse 
events are described in Table 18.
Table 18.
Management of other Treatment-Related Adverse Events
Severity of Event
Management Guidelines
Grade 1
•
Maintain PF-07901801 dose level
•
Provide treatment to control symptoms if applicable
Grade 2 (tolerable)
•
Maintain PF-07901801 dose level
•
Provide treatment to control symptoms if applicable
Grade 2 (intolerable)
•
Hold administration of PF-07901801 until the adverse event recovers 
to Grade ≤1 or to baseline level, then resume treatment with PF-
07901801
Grade 3
•
Hold administration of PF-07901801 until the adverse event recovers 
to Grade ≤1 or to baseline level, then resume treatment with PF-
07901801 
Grade 4
•
Discontinue PF-07901801 unless participant is receiving disease 
control, adverse event recovers to baseline level and treating 
physician recommends continuation of treatment at a lower dose 
level or under a modified schedule
9.1.7 Grading and Management of Infusion-Related Reactions
Infusion-related reactions are not expected to be prevalent in this study. However, in the event 
that infusion-related reactions are observed, they will be graded as described in Table 19. 
Guidelines for management of infusion-related reactions are provided in Table 20. 
Table 19.
Definition of Infusion-Related Reaction by CTCAE Grade
CTCAE Grade
Definition
Grade 1 Infusion-Related Reaction
Mild transient reaction; infusion interruption not indicated; 
intervention not indicated
Grade 2 Infusion-Related Reaction
Therapy or infusion interruption indicated but responds promptly to 
symptomatic treatment (e.g., anti-histamines, NSAIDS, narcotics, IV 
fluids); prophylactic medications indicated for ≤ 24 hours
Grade 3 Infusion-Related Reaction
Prolonged (i.e., not rapidly responsive to symptomatic medication, 
brief interruption of infusion, or both); recurrence of symptoms 
following initial improvement; hospitalization indicated for clinical 
sequelae
Grade 4 Infusion-Related Reaction
Life-threatening consequences; urgent intervention indicated
Note: An acute infusion reaction may occur with an agent that causes cytokine release (e.g., monoclonal antibodies or 
other biological agents). Signs and symptoms usually develop during or shortly after drug infusion and generally 
resolve completely within 24 hours of completion of infusion. Signs/symptoms may include: allergic 
reaction/hypersensitivity (including drug fever); arthralgia (joint pain); bronchospasm; cough; dizziness; dyspnea 
(shortness of breath); fatigue (asthenia, lethargy, malaise); headache; hypertension; hypotension; myalgia (muscle pain); 
nausea; pruritis/itching; rash/desquamation; rigors/chills; sweating (diaphoresis); tachycardia; tumor pain (onset or 
exacerbation of tumor pain due to treatment); urticaria (hives, welts, wheals); vomiting.
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Table 20.
Management of Infusion-Related Reactions Associated with PF-07901801 
Administration
CTCAE Grade
Management Guidelines
Grade 1 Infusion-
Related Reaction
•
The infusion may be stopped or continued at a reduced (50%) infusion rate at the discretion 
of the investigator.
•
If symptoms resolve, the infusion can be re-started or increased, as tolerated, to the baseline 
rate.
•
The participant may receive appropriate further treatment for infusion-related reaction if 
clinically indicated per the site’s standard practice for management of IRR.
Grade 2 Infusion-
Related Reaction
•
The infusion should be stopped.
•
The participant should receive appropriate further treatment with an anti-histamine and/or 
acetaminophen if clinically indicated per the site’s standard practice for management of IRR. 
Further medications can be administered if necessary. 
•
Once symptoms have resolved or reduced to Grade 1, the infusion can be continued at a 
reduced (50%) infusion rate. If after one hour the participant’s symptoms do not return and 
vital signs are stable, the infusion rate may be increased every 30 minutes, as tolerated, to the 
baseline rate.
Grade 3 Infusion-
Related Reaction
•
The infusion should be stopped promptly.
•
The participant must receive appropriate treatment with an anti-histamine and/or 
acetaminophen and/or methylprednisolone or equivalent and, if necessary, further 
medications (i.e., epinephrine, bronchodilator). 
•
Only after the complete resolution to Grade ≤1, and after having received appropriate 
prophylactic medication(s) as described above, the infusion may be resumed at an infusion 
rate of 25%. If after one hour the participant’s symptoms do not return and vital signs are 
stable, the infusion rate may be increased to a maximum of 50%.
•
If after the resumption of infusion, symptoms return (irrespective of grade), the infusion must 
be stopped and the infusion tubing should be disconnected. 
•
The duration of infusion may be prolonged in order to ameliorate IRR but PF-07901801 dose 
does not require reduction.
•
the sponsor medical monitor should be apprised of any ≥ G3 IRR that occurs during the study
Grade 4 Infusion-
Related Reaction
•
The infusion should be stopped promptly and the infusion tubing should be disconnected.
•
The participant should receive appropriate treatment with an anti-histamine and/or 
acetaminophen and/or methylprednisolone (or equivalent) and, if necessary, further 
medications (i.e., epinephrine, bronchodilator). 
•
After discussion with the sponsor medical monitor, the participant  must not receive further 
infusions of PF-07901801 if PF-07901801 is judged by the investigator to be the cause of the 
infusion-related reaction and the investigator feels that implementation of alternative or more 
aggressive prophylaxis would not be sufficient. 
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9.2 Management of Adverse Events Associated with PLD 
General guidelines for dose modifications in response to observed adverse events is presented 
in this section. In consideration that PLD is being used as a standard of care anti-cancer 
therapy in the enrolled participant population and based on investigator and site experience 
with PLD in the enrolled participant population, alternate dose modifications may be 
implemented after discussion with the medical monitor. In general, the PLD dose should not be 
increased after a dose reduction for toxicity; on a participant -specific basis, the investigator 
may discuss a dose increase with the sponsor medical monitor.
9.2.1 PLD Treatment Interruptions
Treatment with PLD may be temporarily suspended for up to 56 days to allow for resolution of 
adverse events. Dose interruptions for reason(s) other than toxicity and re-treatment may be 
allowed in accordance with standard of care if the participant is receiving disease control and 
after discussion with the sponsor medical monitor. In general, if an interruption of more than 
56 days is required due to adverse events, PLD will be permanently discontinued; however, if 
in the judgment of the investigator, the participant is likely to derive disease control from PLD 
after a hold of more than 56 days, study drug may be re-started with approval of the sponsor 
medical monitor. Longer interruptions may be acceptable on a participant-by-participant basis 
at the discretion of the investigator after discussion with the sponsor medical monitor.
9.2.2 PLD Re-Treatment Guidelines
The laboratory parameters described in Table 21 should be met for re-treatment with PLD (i.e., 
initiation of a new cycle).
Table 21.
Requirements for Re-Treatment with PLD
Parameter
Criterion
ANC
≥1.5 × 109/L
Platelet Count
≥75 × 109/L
Bilirubin
≤1.5 × ULN (≤ 2 x ULN if hyperbilirubinemia is due to Gilbert’s 
syndrome)
AST, ALT
≤3 × ULN (<5 × ULN if liver metastases)
Treatment-Related Adverse Event
NCI CTCAE Grade <2 or baseline level (except for alopecia)
9.2.3 PLD Dose Modification Guidelines
Table 22 describes PLD dose reduction levels in the case of PLD-related adverse events.
Table 22.
PLD Dose Modifications
Dose Level
First Dose Reduction
Second Dose Reduction
40 mg/m2
30 mg/m2
22.5 mg/m2
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If more than two dose reductions are required for a participant, the investigator should consult 
with the sponsor medical monitor to determine the appropriate course of action for the 
participant.
In case a participant’s bilirubin level is elevated >1.2 mg/dL due to impaired liver function, the 
dose of PLD should be reduced as follows: serum bilirubin 1.2 to 3.0 mg/dL - give ½ normal 
dose; serum bilirubin > 3 mg/dL - give ¼ normal dose.
9.2.4 Management of Infusion-Related Reactions Associated with PLD 
Infusion-related reactions will be graded as described in Table 19. Management of 
infusion-related reactions associated with PLD administration are described in Table 23.
Table 23.
Management of Infusion-Related Reactions Associated with PLD
CTCAE Grade
Management Guidelines
Grade 1
Grade 2
Grade 3
•
Slow the infusion rate or stop the infusion
•
Provide appropriate further treatment for infusion-related reaction if 
clinically-indicated per the site’s standard practice.
•
If symptoms resolve, the infusion can be re-started at a reduced 
infusion rate.
•
Consider premedications and reduced infusion rate for subsequent 
infusions.
Grade 4
•
Stop the infusion
•
Aggressively manage symptoms per the site’s standard practice for 
management of PLD-associated or any infusion-related reaction
•
Do not retreat with PLD
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9.2.5 Management of Cardiomyopathy Associated with PLD 
Doxorubicin hydrochloride, the active component of PLD, can cause myocardial damage, 
including acute left ventricular failure. The risk of cardiomyopathy is generally proportional to 
the cumulative exposure. Include prior use of other anthracycles or anthracenediones in 
calculations of cumulative dose. The risk of cardiomyopathy may be increased at lower 
cumulative doses in participants with prior mediastinal irradiation.
Because of the risk of cardiomyopathies with Doxorubicin it is important to assess left 
ventricular cardiac function prior to initiation of treatment. Participants will undergo baseline 
Left Ventricular Ejection Fraction (LVEF) determination by ECHO or MUGA scan to be 
performed at screening visit only. This evaluation may be repeated at any time during the study 
if clinically indicated.
9.2.6 Management of Hematologic Adverse Events Associated with PLD 
Participants must have adequate hematological function with no transfusion or colony 
stimulating factor or erythropoiesis-stimulating agent for at least 2 weeks prior to Cycle 1 Day 
1.
Primary prophylactic use of colony stimulating factors or erythropoiesis-stimulating agents or 
blood product transfusions are not permitted during the first 28 days of Phase 1 Cycle 1 (DLT 
evaluation period), unless indicated due to medical emergency.
Therapeutic and prophylactic use of G-CSFs is allowed per ASCO and NCCN guidelines. 
Management of hematologic adverse events associated with PLD administration is described in 
Table 24.
Table 24.
Management of Hematologic Adverse Events Associated with PLD
CTCAE Grade
Management Guidelines
Grade 1 Neutropenia
Grade 1 Thrombocytopenia
Resume treatment with no dose reduction
Grade 2 Neutropenia
Grade 2 Thrombocytopenia
Hold administration of PLD until the adverse event recovers to Grade ≤1 or to 
baseline level, then resume treatment with no dose reduction
Grade 3 Neutropenia
Grade 3 Thrombocytopenia
Hold administration of PLD until the adverse event recovers to Grade ≤1 or to 
baseline level, then resume treatment with no dose reduction
Grade 4 Neutropenia
Grade 4 Thrombocytopenia
Hold administration of PLD until the adverse event recovers to Grade ≤1 or to 
baseline level, then resume treatment with first dose reduction
Management should be guided by the more severe toxicity if neutropenia and thrombocytopenia are both 
observed.
9.2.7 Management of Hand-Foot Syndrome Associated with PLD 
Management of hand-foot syndrome (HFS) associated with PLD administration is described in
Table 25.
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Table 25.
Management of Hand-Foot Syndrome Associated with PLD
CTCAE Grade
Management Guidelines
Grade 1: Mild erythema, swelling, or 
desquamation not interfering with daily 
activities
•
If no previous Grade 3 or Grade 4 HFS: no dose 
adjustment
If previous Grade 3 or Grade 4 HFS: delay dose up to two weeks, 
then decrease dose by 25%
Grade 2: Erythema, desquamation, or 
swelling interfering with but not 
precluding normal physical activities; 
small blisters or ulcerations less than 2 cm 
in diameter
•
Delay dosing up to two weeks or until resolved to Grade 
0 - 1
•
Discontinue if no resolution after two weeks
•
If resolved to Grade 0 – 1 with two weeks and:
•
no previous Grade 3 or Grade 4 HFS: continue treatment 
at previous dose
•
previous Grade 3 or Grade 4 toxicity: decrease dose by 
25%
Grade 3: Blistering, ulceration, or swelling 
interfering with walking or normal daily 
activities; cannot wear regular clothing
•
Delay dosing up to two weeks or until resolved to Grade 
0 – 1, then decrease dose by 25%
Discontinue if no resolution after two weeks
Grade 4: Diffuse or local process causing 
infectious complications, or a bed-ridden 
state or hospitalization
•
Delay dosing up to two weeks or until resolved to Grade 
0 – 1, then decrease dose by 25%
•
Discontinue if no resolution after two weeks
9.2.8 Management of Stomatitis Associated with PLD 
Management of stomatitis associated with PLD administration is described in Table 26.
Table 26.
Management of Stomatitis Associated with PLD
CTCAE Grade
Management Guidelines
Grade 1: Painless ulcers, erythema, or mild soreness
•
If no previous Grade 3 or Grade 4 toxicity:
no dose adjustment
•
If previous Grade 3 or Grade 4 toxicity:
delay dose up to two weeks, then decrease 
dose by 25%
Grade 2: Painful erythema, edema, or ulcers, but can 
eat
•
Delay dosing up to two weeks or until 
resolved to Grade 0 - 1
•
Discontinue if no resolution after two 
weeks
•
If resolved to Grade 0 – 1 with two weeks 
and:
•
no previous Grade 3 or Grade 4 stomatitis:
continue treatment at previous dose
•
previous Grade 3 or Grade 4 toxicity:
decrease dose by 25%
Grade 3: Painful erythema, edema, or ulcers, and 
cannot eat
•
Delay dosing up to two weeks or until 
resolved to Grade 0 – 1, then decrease dose 
by 25% and return to original dose interval
•
Discontinue if no resolution after two 
weeks
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Table 26.
Management of Stomatitis Associated with PLD
CTCAE Grade
Management Guidelines
Grade 4: Requires parenteral or enteral support
•
Delay dosing up to two weeks or until 
resolved to Grade 0 – 1, then decrease dose 
by 25% and return to original dose interval
•
Discontinue if no resolution after two 
weeks
9.2.9 Secondary Oral Neoplasms Related to PLD Administration
Secondary oral cancers, primarily squamous cell carcinoma, have been reported from 
post-marketing experience with patients with long-term (more than one year) exposure. 
Examine participants at regular intervals for the presence of oral ulceration or with any oral 
discomfort that may be indicative of secondary oral cancer.
9.2.10 Extravasation and Tissue Necrosis Related to PLD Administration
Infusion should be discontinued for burning or stinging sensation or other evidence indicating 
perivenous infiltration or extravasation. Manage confirmed or suspected extravasation as 
follows:
•
Do not remove the needle until attempts are made to aspirate extravasated fluid
•
Do not flush the line
•
Avoid applying pressure to the site
•
Apply ice to the site intermittently for 15 minutes four times each day for three days
•
If the extravasation is in an extremity, elevate the extremity
9.3 Management of Adverse Events not Attributable to a Specific Study Treatment
Guidelines for managing adverse events when attribution to either TTI-622 or PLD is not 
possible in the opinion of the investigator are provided in Table 27. Discussion with the 
medical monitor is recommended to ensure homogeneity in adverse event management across 
all participants to the extent possible. 
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Table 27.
General Guidelines for Management of Adverse Events when Attribution is 
not Possible in the Opinion of the Investigator
Observation
Management Guidelines
•
Hematologic Toxicity1Grade ≥ 3 
neutropenia (ANC < 1 x 109/L)
•
Grade ≥ 3 thrombocytopenia(platelets 
<50 x 109/L)
•
Grade ≥ 3 anemia
•
Hemoglobin < 8 g/dL
Non-Hematologic Toxicity1Grade ≥ 3 events 
excluding:
•
Sub-optimally treated nausea, vomiting, 
diarrhea
•
Alopecia
•
Transient fatigue of a duration consistent 
with that associated with doxorubicin 
treatment (1-2 weeks)
•
Infusion-related reaction in the absence of 
described prophylaxis
•
Laboratory abnormalities that are 
asymptomatic and/or judged by the 
investigator as not clinically significant for 
the patient
First Appearance
•
Delay study treatment until recovery to 
Grade ≤ 1 or baseline with ANC 
>1.5 x 109/L and platelets ≥75x 109/L. If no 
recovery after a delay of >21 days, 
discontinue PF-07901801 and remove 
participant from study.
First Re-Appearance
•
Delay study treatment until recovery to 
Grade ≤1 or baseline. If no recovery after a 
delay of >21 days, discontinuePF-07901801 
and remove participant from study.
•
Reduce PF-07901801 dose level by one dose 
level.
•
No change in PLD dose level. 
Second Re-Appearance
•
Reduce PF-07901801 dose level by one 
additional dose level.
•
No change in PLD dose level.
Third Re-Appearance
•
Reduce PLD dose level by one dose level.
•
No change from previous PF-07901801 dose 
level.
Fourth Re-Appearance
•
Reduce PLD dose level by one additional 
dose level.
•
No change from previous PF-07901801 dose 
level.
Hematologic Toxicity
•
Grade 1 or Grade 2
•
Non-Hematologic ToxicityGrade 1 or Grade 
2
•
No treatment delay
•
No change in dose level
1 Interventional or supportive care may be introduced (e.g., G-CSF for neutropenia)
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10 STUDY ASSESSMENTS
The procedures and assessments that will be conducted during this study are described in this 
section and summarized in the Schedule of Assessments (Table 28). Detailed instructions 
regarding all laboratory procedures, including collection and handling of samples, will be 
included in the study Laboratory Manual provided by the sponsor.
The schedule for collection of blood samples for analysis of  PF-07901801 concentrations is 
presented in the Schedule of Assessments (Table 29). The schedule for collection of blood 
samples for analysis of PLD concentrations is presented in Table 30. The schedule for 
collection of samples for anti-drug antibody analyses is presented in Table 31. The schedule 
for collection of samples for biomarker/pharmacodynamics analyses is presented in Table 32. 
Written informed consent must be granted by each participant prior to the initiation of any 
study procedure or assessment.
Planned timepoints for all safety assessments are provided in the Schedule of Assessments 
(Table 28). Unscheduled safety measurements may be obtained at any time during the study to 
assess any perceived safety issues.
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Table 28.
Schedule of Assessment
ACTIVITY
Screening
Cycle 1
Day in Cycle
Cycle 2, Cycle 3
Day in Cycle
(± 3 days)
Cycle 4
Day in Cycle
(± 3 days)
Subsequent 
Cycles Day in 
Cycle
(± 3 days)
End of 
Treatment
Visitz
Safety 
Follow-
Up
Visitaa
Long-
Term 
Follow-Up
Period
Day -28 to -
1
1
8
15
22
1
8
15
22
1
15
1
15
Informed Consent
X
Demographics
X
Inclusion and exclusion criteria
X
Medical history
X
Cancer history
X
Physical exam, vital signsa
X
X
X
X
X
X
X
Brief physical exam, vital signsb
X
X
X
X
X
X
LVEFc
X
ECOG PS
X
X
X
X
X
X
Serum chemistryd
X
Xr
Xr
Xr
Xr
Xr
Xr
Xr
Xr
Xr
Xr
X
Hematologye
X
Xr
Xr
Xr
Xr
Xr
Xr*
Xr
Xr*
Xr
Xr
Xr
Xr
X
Coagulationf
X
Xr
ECGg
X
Xr
Xr
Xr
Xu
X
Pregnancy testh
X
X
X
X
X
X
Radiologic assessment of disease statusi
X
Xi
X
X
Administer PLDj
X
X
X
X
Administer PF-07901801k (12 and 24 
mg/kg dose levels only)
Xs
Xs
Xs
Xs
X
X
X
X
X
X
Administer PF-07901801k (48 mg/kg dose 
level only)
Xs
Xs
X
X
X
X
X
X
Adverse events
Ongoing
Concomitant medications, procedures
Ongoing
Blood collection for CA-125
X
X
X
X
X
X
X
Blood collection for PLDl
Xee
Xee
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Table 28.
Schedule of Assessment
ACTIVITY
Screening
Cycle 1
Day in Cycle
Cycle 2, Cycle 3
Day in Cycle
(± 3 days)
Cycle 4
Day in Cycle
(± 3 days)
Subsequent 
Cycles Day in 
Cycle
(± 3 days)
End of 
Treatment
Visitz
Safety 
Follow-
Up
Visitaa
Long-
Term 
Follow-Up
Period
Day -28 to -
1
1
8
15
22
1
8
15
22
1
15
1
15
Blood collection for PF-07901801
concentrationll, cc
Xff
Xff
Xff
Xff
Xff
Xff
Xff
Xff
Xff
Xff
X
X
Blood collection for Biomarker/PDm
Xdd
X
X
Xdd
X
X
Xw,x
Blood collection for ADAs and NAbs of
PF-07901801n
X
X
X
Xv
X
Xbb
See notebb
Tissue collection for Biomarker/PDo
Xq
Xt,y
Survival, initiation of new anti-cancer 
therapyp
X
a.
Complete physical examination by body system, including vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight); height collected during screening only
b.
Symptom-directed physical examination, with vital signs limited to temperature, blood pressure, pulse rate, respiratory rate
c.
Assessed by transthoracic echocardiogram or MUGA at screening. Note:.Additional LVEF assessments may be performed as clinically indicated and in accordance with the 
PLD SRSD (Doxil® USPI).
d.
Glucose, sodium, potassium, calcium, chloride, phosphate, bicarbonate, blood urea nitrogen or urea, creatinine, total protein, albumin, alkaline phosphatase, aspartate 
aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, indirect bilirubin, uric acid, calcium, magnesium, lactate dehydrogenase (LDH)
e.
Hemoglobin, hematocrit, platelets, white blood cells (WBC), neutrophils, lymphocytes, eosinophils, basophils, monocytes, WBC with automated 5-part differential, RBC, 
absolute reticulocytes, reticulocytes %, MCH, MCV, RDW
f.
International normalized ratio (INR)/prothrombin time (PT), partial thromboplastin time (PTT). To be repeated more frequently) if clinically-indicated (e.g., INR/PT for 
participants on anti-coagulants)
g.
12-lead ECG with triplicate assessments obtained with participant in supine position and within 10 minutes total time; to be performed prior to Cycle 1, Cycle 3, Cycle 4 and 
Cycle 6; prior to every second cycle beginning with Cycle 7; and at the Safety Follow-Up Visit.
h.
Pregnancy tests will be performed in WOCBP. A serum pregnancy test is required at screening. Following screening, pregnancy tests may be urine or serum tests, and must 
have a sensitivity of at least 25 mIU/mL. A pregnancy test must be performed and be negative prior to treatment with IP at baseline and at subsequent treatment visits.
Participants will also be counseled on the use of appropriate contraceptive methods at these timepoints.
i.
Assessed objectively by CT, MRI or PET/CT; the method used at baseline should be used for the duration of participant participation. Performed every 8 ± 1 week until Week 
48 or participant has been on study for one year, and every 12 ± 2 weeks thereafter. CR or PR should be confirmed by repeat assessment at least four weeks after initial 
observation; treatment can continue during the interval between initial observation and confirmation. In the event that a participant is removed from the study in the absence of 
radiologic disease progression, a radiologic disease assessment should be performed at the Safety Follow-Up Visit if not performed within the previous four weeks and disease 
status should be assessed during Long-Term Follow-Up until radiologic demonstration of progression or initiation of new anti-cancer therapy, whichever occurs first
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Table 28.
Schedule of Assessment
ACTIVITY
Screening
Cycle 1
Day in Cycle
Cycle 2, Cycle 3
Day in Cycle
(± 3 days)
Cycle 4
Day in Cycle
(± 3 days)
Subsequent 
Cycles Day in 
Cycle
(± 3 days)
End of 
Treatment
Visitz
Safety 
Follow-
Up
Visitaa
Long-
Term 
Follow-Up
Period
Day -28 to -
1
1
8
15
22
1
8
15
22
1
15
1
15
j.
PLD should be administered through a free-flowing catheter at 40 mg/m2 by intravenous infusion. The initial infusion rate should be 1 mg/min to minimize the risk of infusion 
reactions. If no infusion-related adverse reactions are observed, the rate of infusion can be increased to complete administration of the drug over one hour in accordance with 
institutional guidelines. Medications for treatment of infusion-related reaction and CPR equipment must be available before start of treatment; prophylaxis in accordance with 
institutional guidelines is acceptable
k.
PF-07901801 is administered intravenously through a free-flowing catheter; the duration of infusion is dependent on dose level: dose levels less than or equal to 33 mg/kg infused 
over 60 min and doses greater than 33 mg/kg infused over 90 minutes and will have doses equal to or less than 2500 mg in 250 mL and doses 2501 mg or more in 500 mL or 
neat drug if the drug volume is over 500 mL. Prophylaxis for potential infusion-related reaction in accordance with institutional guidelines is acceptable. If Cycle 1 loading doses 
are implemented, all dosing and lab schedules for the 48 mg/kg dose will follow the schedules for dose levels 12 mg/kg and 24 mg/kg
l.
Detailed sample collection schedule provided in Table 30
ll      Detailed sample collection schedule provided in Table 29
m.
Detailed sample collection schedule provided in Table 32
n.
Detailed sample collection schedule provided in Table 31
o.
Detailed sample collection schedule provided in Table 32
p.
Assessed every 12 ± 2 weeks; telephone contact is acceptable
q.
Newly-acquired FFPE/NBF tumor tissue (tumor block preferred; if tumor block is not available, unstained slides are acceptable). Tumor tissue to be collected anytime after 
signing of informed consent and prior to treatment on Cycle 1 Day 1. Archival tissue from most recent biopsy is acceptable if fresh tissue specimen is not available at 
screening. The baseline tissue chosen should be the most recently collected specimen before the start of the study therapy and after the most recent systemic therapy. Detailed 
sample collection schedule provided in Table 32
r.
Does not need to be performed if previous assessment was within 72 previous hours
s.
Participants should be observed for one hour after infusion with vital signs assessment in 30-minute intervals for signs of infusion-related reaction in Cycle 1; the observation 
period may be removed at the investigator’s discretion in participants who tolerate the infusion well and do not experience infusion-related reaction during Cycle 1.
t.
Target date for FFPE/NBF tumor tissue collection date is Cycle 2 Day 1 but can be collected anytime within 7 days prior to and up to 14 days after Cycle 2 Day 1 (i.e. Tumor 
tissue should be collected within a 21-day window); other times may be acceptable after consultation with sponsor; tumor block preferred; if block is not available, unstained
slides are acceptable. Detailed sample collection schedule provided in Table 32
u.
Prior to initiation of every second cycle (Cycle 7, Cycle 9, Cycle 11, etc)
v.
Cycle 5, Cycle 7, Cycle 9 and every second cycle thereafter (Cycle 11, Cycle 13, etc)
w.
Cycle 5, Cycle 7, Cycle 9 and every second cycle thereafter (Cycle 11, Cycle 13, etc): blood collection for assessment of Peripheral Receptor Occupancy, Nanostring/RNA 
Sequencing, TCRVβ. Refer to Table 32 for details
x.
Cycle 5, Cycle 9, Cycle 13 and every fourth cycle thereafter (Cycle 17, Cycle 21, etc): blood collection for assessment of Adaptive and Innate Immunity only. Refer to 
Table 32 for details
y.
FFPE/NBF tumor biopsies may be collected at response, progression, at the time of any surgical intervention, end of treatment and at investigator's discretion; tumor block 
preferred; if block is not available, unstained slides are acceptable. Detailed sample collection schedule provided in Table 32
z.
Seven ± three days after last administration of study treatment
aa.
To be performed 30 + five days after last administration of study treatment or before initiation of subsequent anti-cancer therapy, whichever occurs first
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Table 28.
Schedule of Assessment
ACTIVITY
Screening
Cycle 1
Day in Cycle
Cycle 2, Cycle 3
Day in Cycle
(± 3 days)
Cycle 4
Day in Cycle
(± 3 days)
Subsequent 
Cycles Day in 
Cycle
(± 3 days)
End of 
Treatment
Visitz
Safety 
Follow-
Up
Visitaa
Long-
Term 
Follow-Up
Period
Day -28 to -
1
1
8
15
22
1
8
15
22
1
15
1
15
bb. Participants with an unresolved AE at the Safety Follow-Up visit considered possibly related to ADA formation may be asked to return to the clinic for ADA blood sampling at 
approximately 3-month intervals (if feasible given the underlying disease) until the AE or its sequelae resolve or stabilize at a level acceptable to the investigator and sponsor 
up to a maximum of 12 months 
cc.
All post-dose sample collection times are relative to the start of the last infusion of PF-07901801
dd. These visits have multiple collection timepoints, see Table 32 for more details
ee.
These visits have multiple collection timepoints, see Table 30 for more details
ff.
These visits have multiple collection timepoints, see Table 29 for more details
* Only for 48mg/kg dose level. May be completed by a local lab
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Table 29.
Sample Collection Schedule for Analysis of PF-07901801 Concentration
Cycle
Day
Nominal Time
Allowable Time Window
1
1
pre-infusion (within 30 min)
1
EOI
+ 5 min
1
T0 + 2 hra
±15 min
1
T0 + 4 hra
±15 min
8
pre-infusion (within 30 min)
8
EOI
+ 5 min
15
pre-infusion (within 30 min)
15
EOI
+ 5 min
22
pre-infusion (within 30 min)
22
EOI
+ 5 min
2
1
pre-infusion (within 30 min)
1
EOI
+ 5 min
15
pre-infusion (within 30 min)
15
EOI
+ 5 min
15
T0 + 2 hra
±15 min
15
T0 + 4 hra
±15 min
3
1
pre-infusion (within 30 min)
1
EOI
+ 5 min
15
pre-infusion (within 30 min)
15
EOI
+ 5 min
4
1
pre-infusion (within 30 min)
1
EOI
+ 5 min
15
pre-infusion (within 30 min)
15
EOI
+ 5 min
15
T0 + 2 hra
±15 min
15
T0 + 4 hra
±15 min
5+ (Every other cycle)
1
pre-infusion (within 30 min)
1
EOI
+ 5 min
15
pre-infusion (within 30 min)
15
EOI
+ 5 min
EOT
X
SFU
X
On Day 1 of each cycle, PLD infusion precedes PF-07901801 infusion. Samples should be collected from the arm contralateral to that used for infusion. If a port is used for 
infusion, the port should be thoroughly flushed before sample collection.
EOI=immediately after the end of infusion PF-07901801 (ie, post-flush); EOT=End of Treatment; SFU=Safety Follow-Up; T0=start time of last PF-07901801 infusion;
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Table 29.
Sample Collection Schedule for Analysis of PF-07901801 Concentration
Cycle
Day
Nominal Time
Allowable Time Window
Note: For treatment visits where PLD and PF-07901801 are both administered, collect pre-infusion sample before administration of either the combination product or PF-
07901801
X: Anytime during the visit
Table 30.
Sample Collection Schedule for Analysis of PLD Concentration
Cycle
Day
Nominal Time
Allowable Time Window
1
1
pre-infusion (within 30 min)a
1
EOIb
+ 2 min
4
1
pre-infusion (within 30 min)a
1
EOIb
+ 2 min
EOI=immediately after the end of infusion of PLD
a. Pre-dose sample of PLD before infusion/administration of ANY drug for treatment visits where PLD and PF-07901801 are both administered
b. Sample relative to last PLD infusion
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Table 31.
Sample Collection Schedule for Analysis of PF-07901801 Anti-Drug Antibodies
Cycle 1
Cycle 2
Cycle 3
Cycle 4
Cycle 51
End of 
Treatment
Visit
Safety
Follow-Up 
Visit2
Long-term 
Follow-Up 
Period2
D1
D8
D15
D22
D1
D15
D1
D15
D1
D15
D1
D15
PLD 
Administration
●
●
●
●
●
PF-07901801 
Administration 
(Dose levels 12 
and 24 mg/kg)
●
●
●
●
●
●
●
●
●
●
●
●
PF-07901801 
Administration 
(Dose level 48 
mg/kg)3
●
●
●
●
●
●
●
●
●
●
Collection
Pre
Pre
Pre
Pre
Pre
X
X
On Day 1 of each cycle, PLD infusion precedes PF-07901801 infusion. Samples should be collected from the arm contralateral to that used for infusion. If a port is used for 
infusion, the port should be thoroughly flushed before sample collection.
Pre: Prior to initiation of any treatment on this study day
X: Anytime during the visit
1 Cycle 5, Cycle 7, Cycle 9 and every second cycle thereafter (Cycle 11, Cycle 13, etc.)
2 Participants with an unresolved AE at the Safety Follow-Up visit considered possibly related to ADA formation may be asked to return to the clinic for ADA blood sampling at 
approximately 3-month intervals (if feasible given the underlying disease) until the AE or its sequelae resolve or stabilize at a level acceptable to the investigator and sponsor up 
to a maximum of 12 months. 
3 If Cycle 1 loading doses are implemented, all dosing and lab draw schedules for the 48 mg/kg dose will follow the schedules for dose levels 12 mg/kg and 24 mg/kg.
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Table 32.
Sample Collection Schedule for Analysis of PF-07901801 Biomarkers/Pharmacodynamics
Cycle
Screening
Cycle 1
Cycle 2
Cycle 3
Cycle 4
Cycle 51
D1
D8
D15
D22
D1
D15
D1
D15
D1
D15
D1
D15
PLD Administration
●
●
●
●
●
PF-07901801 Administration 
(Dose levels 12 mg/kg and 24 
mg/kg)
●
●
●
●
●
●
●
●
●
●
●
●
PF-07901801 Administration 
(Dose level 48 mg/kg)11
●
●
●
●
●
●
●
●
●
●
Peripheral Receptor 
Occupancy10
(Expansion cohort: if RP2D is 
12 mg/kg or 24 mg/kg or the 
respective DL-1 or DL-210)
Pre2
EOI3
Pre2
Pre2
EOI3
Pre2
Pre2
Pre2
Peripheral Receptor 
Occupancy10
(Expansion cohort: if RP2D is 
48 mg/kg or the respective 
DL-1 or DL-210)
Pre2
EOI3
Pre2
Pre2
EOI3
Pre2
Pre2
Pre2
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Table 32.
Sample Collection Schedule for Analysis of PF-07901801 Biomarkers/Pharmacodynamics
Cycle
Screening
Cycle 1
Cycle 2
Cycle 3
Cycle 4
Cycle 51
D1
D8
D15
D22
D1
D15
D1
D15
D1
D15
D1
D15
Cytokines
Pre2
EOI3
2h4
4h5
Pre2
Pre2
EOI3
2h4
Pre2
Nanostring/RNA Sequencing
Pre2
Pre2
Pre2
Pre2
Pre2
Pre2
TCRVβ
Pre2
Pre2
Pre2
Pre2
Pre2
NGS
Pre2
Adaptive and Innate Immunity
Pre2
Pre2
Pre2,6
Tumor Biopsy
X7
Pre2,8
Pre2,9
On Day 1 of each cycle, PLD infusion precedes PF-07901801 infusion. Samples should be collected from the arm contralateral to that used for infusion. If a port is used for 
infusion, the port should be thoroughly flushed before sample collection.
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Table 32.
Sample Collection Schedule for Analysis of PF-07901801 Biomarkers/Pharmacodynamics
Cycle
Screening
Cycle 1
Cycle 2
Cycle 3
Cycle 4
Cycle 51
D1
D8
D15
D22
D1
D15
D1
D15
D1
D15
D1
D15
1.
Cycles 5, 7, 9 and every second cycle thereafter (Cycle 11, Cycle 13, etc.), except for Adaptive and Innate Immunity sample,6.
2.
Pre-dose samples are to be collected prior to any infusion of any study treatment on this indicated visit
3.
Samples to be collected immediately after the end of infusion of PF-07901801 (i.e. post flush) (+ 5 min window)
4.
Samples to be collected at PF-07901801 T0 + 2hr (±15 min window), where T0= start time of last PF-07901801 infusion 
5.
Samples to be collected at PF-07901801 T0 + 4hr (±15 min window), where T0= start time of last PF-07901801 infusion
6.
Sample for adaptive and innate immunity to be collected every fourth cycle (Cycle 5, Cycle 9, Cycle 13, Cycle 17, etc.) 
7.
Newly-acquired FFPE/NBF tumor tissue (tumor block preferred; if tumor block is not available, unstained slides are acceptable). Tumor tissue to be collected anytime after 
signing of informed consent and prior to treatment on Cycle 1 Day 1. Archival tissue from most recent biopsy is acceptable if fresh tissue specimen is not available at screening. 
The baseline tissue chosen should be the most recently collected specimen before the start of the study therapy and after the most recent systemic therapy.
8.
Target date for FFPE/NBF tumor tissue collection is Cycle 2 Day 1 but can be collected anytime within 7 days prior to and up to 14 days after Cycle 2 Day 1 (i.e. Tumor 
tissue should be collected within a 21-day window); other times may be acceptable after consultation with sponsor. Tumor block preferred; if block is not available, unstained 
slides are acceptable 
9.
FFPE/NBF Tumor biopsies may be collected at response, progression, at the time of any surgical intervention, end of treatment and at investigator's discretion; tumor block 
preferred; if tumor block is not available, unstained slides are acceptable
10. Peripheral Receptor Occupancy samples will only be collected from approximately 12 participants in the expansion cohort (at RP2D). Please refer to Section 10.3 and Table 15
for more details. 
11. If Cycle 1 loading doses are implemented, all dosing and lab draw schedules for the 48 mg/kg dose will follow the schedules for dose levels 12 mg/kg and 24 mg/kg.
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10.1 Pharmacokinetics
10.1.1 PF-07901801 Concentration
Blood samples for the PK analysis of PF-07901801 concentrations will be collected into 
appropriately labeled tubes for measurement of PF-07901801 concentrations at the times 
specified in the Schedule of Assessments (Table 28). Instructions for the collection and 
handling of biological samples will be provided in the laboratory manual or by the sponsor.
All efforts will be made to obtain the samples at the exact nominal time relative to dosing. 
Collection of samples within the sampling time window specified in the SoA will not be 
captured as a protocol deviation, as long as the exact time (24 hour clock time) of the 
collection is noted on the source document and the CRF.
If possible, all blood for PK should be taken from a peripheral vein or from the lumen of a 
central venous catheter of the contralateral infusion arm on dosing days.
Samples collected for measurement of PF-07901801 concentrations will be analyzed using 
validated analytical methods in compliance with applicable SOPs.
Samples collected for analyses of PF-07901801 concentrations may also be used to evaluate 
safety or efficacy aspects related to concerns arising during or after the study or evaluation of 
the bioanalytical method. These data will be used for internal exploratory purposes and not 
reported in the clinical study report.
The PK samples must be processed and shipped as indicated in the instructions provided to the 
investigator site to maintain sample integrity. Any deviations from the PK sample handling 
procedure (eg, sample collection and processing steps, interim storage or shipping conditions), 
including any actions taken, must be documented and reported to the sponsor. On a case by 
case basis, the sponsor may make a determination as to whether sample integrity has been 
compromised.
10.2 Immunogenicity Assessments
10.2.1 Anti-PF-07901801 Antibody (ADA) and Neutralizing Anti-PF-07901801 Antibody 
(NAb)
Blood samples will be collected for determination of ADA and NAb for PF-07901801 into 
appropriately labeled tubes at times specified in the SoA. Instructions for the collection and 
handling of biological samples will be provided in the laboratory manual. The actual date and 
time (24 hour clock time) of each sample will be recorded. 
Samples collected for determination of ADA and NAb will be analyzed using a validated 
analytical method in compliance with applicable SOPs. Samples determined to be positive for 
ADA may be further characterized for NAb.
Samples may also be used for additional characterization of the immune response and/or 
evaluation of the bioanalytical method, or for other internal exploratory purposes. These data 
will be used for internal exploratory purposes and not reported in the clinical study report.
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The immunogenicity samples must be processed and shipped as indicated in the instructions 
provided to the investigator site to maintain sample integrity. Any deviations from the 
immunogenicity sample handling procedure (eg, sample collection and processing steps, 
interim storage, or shipping conditions), including any actions taken, must be documented and 
reported to the sponsor. On a case by case basis, the sponsor may make a determination as to 
whether sample integrity has been compromised.
10.3 Biomarker and Pharmacodynamics Assessments
Unless prohibited by local regulations or ethics committee decision, blood and tumor 
biospecimens will be collected to analyze DNA, RNA, protein or metabolic biomarkers for 
achieving study objectives. Specific biomarker and pharmacodynamic analyses may not be 
performed if emerging data indicate that they would no longer support study objectives. 
Biomarker and pharmacodynamic analyses may include but are not limited to peripheral CD47 
receptor occupancy, serum cytokines, nanostring/RNA sequencing, TCR sequencing, whole 
exome sequencing/NGS, multiplex immunohistochemistry and immune function assays.
Peripheral Receptor Occupancy samples will only be collected from approximately 12 
participants in the expansion cohort (12mg/kg, 24mg/kg or 48mg/kg or their respective DL-1 
or DL-2, ie the RP2D).
Refer to Table 32 for the schedule for collection of samples for biomarker/pharmacodynamics 
analyses and laboratory manual for sample collection, processing and shipping.
11 SCHEDULE OF PROCEDURES AND ASSESSMENTS
The following procedures and assessments will be performed at the indicated timepoints. 
Screening Visit (Day -28 to -1)
•
Informed consent
•
Demographics
•
Inclusion and exclusion criteria
•
Medical history
•
Cancer history
•
Complete physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight), height
•
LVEF by transthoracic echocardiogram or MUGA. Per investigator discretion, this can 
be performed anytime after screening  if clinically indicated
•
ECOG PS
•
Serum chemistry
•
Hematology 
•
Coagulation 
•
12-lead ECG
•
Serum pregnancy test and counseled on appropriate contraception (female participants 
of childbearing potential only)
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•
Radiologic assessment of disease status using CT, MRI or PET/CT; the method used at 
baseline should be used for the duration of participant participation
•
Collection of FFPE/NBF tumor tissue for biomarkers/pharmacodynamics (tumor block 
preferred; if tumor block is not available, unstained slides are acceptable). Tumor tissue 
to be collected anytime after signing of informed consent and prior to treatment on 
Cycle 1 Day 1. Archival tissue from most recent biopsy is acceptable if fresh tissue 
specimen is not available at screening. The baseline tissue chosen should be the most 
recently collected specimen before the start of the study therapy and after the most 
recent systemic therapy
Cycle 1 Day 1
•
Complete physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight)
•
ECOG PS
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Coagulation (unless previous assessment was performed within previous 72 hours)
•
12-lead ECG (unless previous assessment was performed within previous 72 hours)
•
Urine or serum pregnancy test (female participants of childbearing potential only)  must 
be performed and be negative prior to treatment and counseled on appropriate 
contraception
•
Administer PLD
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
60-minute observation period after PF-07901801 infusion; vital signs assessed in 30-
minute intervals
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for CA-125
•
Blood collection for PF-07901801 concentration
•
Blood collection for PLD concentration
•
Blood collection for biomarkers/pharmacodynamics
•
Blood collection for PF-07901801 anti-drug antibodies
Cycle 1 Day 8 
•
Brief physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate)
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg)
•
60-minute observation period after PF-07901801 infusion; vital signs assessed in 30-
minute intervals
•
Adverse events
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•
Concomitant medications and procedures
•
Blood collection for PF-07901801 concentration
•
Blood collection for biomarkers/pharmacodynamics
Cycle 1 Day 15 
•
Brief physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate)
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
60-minute observation period after PF-07901801 infusion; vital signs assessed in 30-
minute intervals
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for PF-07901801 concentration
•
Blood collection for biomarkers/pharmacodynamics
Cycle 1 Day 22 
•
Brief physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate)
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg)
•
60-minute observation period after PF-07901801 infusion; vital signs assessed in 30-
minute intervals
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for PF-07901801 concentration
Cycle 2 Day 1
•
Complete physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight)
•
ECOG PS
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
12-lead ECG (unless previous assessment was performed within previous 72 hours)
•
Urine or serum pregnancy test (female participants of childbearing potential only) must 
be performed and be negative prior to treatment and counseled on appropriate 
contraception
•
Administer PLD
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
Adverse events
•
Concomitant medications and procedures
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•
Blood collection for CA-125
•
Blood collection for PF-07901801 concentration
•
Blood collection for biomarkers/pharmacodynamics
•
Blood collection for PF-07901801 anti-drug antibodies
•
Collection of FFPE/NBF tumor tissue for biomarkers/pharmacodynamics (tumor block 
preferred; if tumor block is not available, unstained slides are acceptable). Target date 
for tumor tissue collection is Cycle 2 Day 1 but can collected anytime within seven 
days prior to and up to 14 days after this visit (ie, tumor tissue should be collected 
within a 21-day window), other times may be acceptable after consultation with 
sponsor.
Cycle 2 Day 8 (48 mg/kg dose level only)
•
Hematology, unless previous assessment was performed within previous 72 hours, may 
be completed by a local lab.
Cycle 2 Day 15
•
Brief physical examination
•
Vital signs (temperature, blood pressure, pulse rate, and respiratory rate)
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for PF-07901801 concentration
•
Blood collection for biomarkers/pharmacodynamics
Cycle 2 Day 15 and Beyond (at any visit)
•
FFPE/NBF Tumor biopsies may be collected at response, progression, at the time of 
any surgical intervention, end of treatment and at investigator's discretion for 
biomarkers/pharmacodynamics; tumor block preferred; if block is not available, 
unstained slides are acceptable
Cycle 2 Day 22 (48 mg/kg dose level only)
•
Hematology, unless previous assessment was performed within previous 72 hours, may 
be completed by a local lab.
Cycle 3 Day 1
•
Complete physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight)
•
ECOG PS
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
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•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Urine or serum pregnancy test (female participants of childbearing potential only) must 
be performed and be negative prior to treatment and counseled on appropriate 
contraception 
•
12-lead ECG (unless previous assessment was performed within previous 72 hours)
•
Radiologic assessment of disease status (unless performed within previous 7 days)
•
Administer PLD 
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for CA-125
•
Blood collection for PF-07901801 concentration
•
Blood collection for biomarkers/pharmacodynamics
•
Blood collection for PF-07901801 anti-drug antibodies
Cycle 3 Day 8 (48 mg/kg dose level only)
•
Hematology, unless previous assessment was performed within previous 72 hours, may 
be completed by a local lab
Cycle 3 Day 15
•
Brief physical examination
•
Vital signs (temperature, blood pressure, pulse rate, and respiratory rate)
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for PF-07901801 concentration
•
Blood collection for biomarkers/pharmacodynamics
Cycle 3 Day 22 (48 mg/kg dose level only)
•
Hematology, unless previous assessment was performed within previous 72 hours, may 
be completed by a local lab.
Cycle 4 Day 1
•
Complete physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight)
•
ECOG PS
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
12-lead ECG (unless previous assessment was performed within previous 72 hours)
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•
Urine or serum pregnancy test (female participants of childbearing potential only) must 
be performed and be negative prior to treatment and counseled on appropriate 
contraception
•
Administer PLD
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for CA-125
•
Blood collection for PF-07901801 concentration
•
Blood collection for PLD concentration
•
Blood collection for biomarkers/pharmacodynamics
•
Blood collection for PF-07901801 anti-drug antibodies
Cycle 4 Day 15
•
Brief physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate)
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for PF-07901801 concentration
Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, etc. (every odd cycle)
•
Complete physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight)
•
ECOG PS
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Urine or serum pregnancy test (female participants of childbearing potential only) must 
be performed and be negative prior to treatment and counseled on appropriate 
contraception
•
12-lead ECG (unless previous assessment was performed within previous 72 hours)
•
Radiologic assessment of disease status (unless performed within previous seven days)
•
Administer PLD
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for CA-125
•
Blood collection for PF-07901801 concentration
•
Blood collection for biomarkers/pharmacodynamics
•
Blood collection for PF-07901801 anti-drug antibodies
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Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, etc. (every fourth cycle)
•
Blood collection for biomarkers/pharmacodynamics 
Cycle 5 Day 15, Cycle 7 Day 15, Cycle 9 Day 15, etc. (every odd cycle)
•
Brief physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate)
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg) 
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for PF-07901801 concentration
Cycle 6 Day 1, Cycle 8 Day 1, Cycle 10 Day 1, etc. (every even cycle)
•
Complete physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight)
•
ECOG PS
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Urine or serum pregnancy test (female participants of childbearing potential only) must 
be performed and be negative prior to treatment and counseled on appropriate 
contraception
•
Blood collection for CA-125
•
Administer PLD
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
Adverse events
•
Concomitant medications and procedures
Cycle 6 Day 15, Cycle 8 Day 15, Cycle 10 Day 15, etc. (every even cycle)
•
Brief physical examination
•
Vital signs (temperature, blood pressure, pulse rate, and respiratory rate)
•
Serum chemistry (unless previous assessment was performed within previous 72 hours)
•
Hematology (unless previous assessment was performed within previous 72 hours)
•
Administer PF-07901801 (12 mg/kg, 24 mg/kg, 48 mg/kg)
•
Adverse events
•
Concomitant medications and procedures
End-of-Treatment Visit (7 ± 3 days after last administration of study treatment)
•
Complete physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight)
•
Adverse events
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•
Concomitant medications and procedures
•
Blood collection for PF-07901801 concentration 
•
Blood collection for PF-07901801 anti-drug antibodies
Safety Follow-Up Visit (30 + 5 days after last administration of study treatment or before 
initiation of subsequent anti-cancer therapy, whichever occurs soonest)
•
Complete physical examination
•
Vital signs (temperature, blood pressure, pulse rate, respiratory rate, weight)
•
ECOG PS
•
Serum chemistry (unless performed within previous 72 hours)
•
Hematology (unless performed within previous 72 hours)
•
12-lead ECG
•
Urine or serum pregnancy test (female participants of childbearing potential only) and 
counseled on appropriate contraception
•
Radiologic assessment of disease status (unless performed within previous 7 days)
•
Adverse events
•
Concomitant medications and procedures
•
Blood collection for CA-125
•
Blood collection for PF-07901801 concentration
•
Blood collection for PF-07901801 anti-drug antibodies
Long-Term Follow-Up Period
•
Radiologic assessment of disease status (participants who have not experienced disease 
progression)
•
Participants with an unresolved AE at the Safety Follow-Up visit considered possibly 
related to ADA formation may be asked to return to the clinic for ADA blood sampling 
at approximately 3-month intervals (if feasible given the underlying disease) until the 
AE or its sequelae resolve or stabilize at a level acceptable to the investigator and 
sponsor up to a maximum of 12 months.
•
Survival and initiation of new anti-cancer therapies (assessed every 12 ± 2 weeks; 
telephone contact is acceptable)
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12 STATISTICAL CONSIDERATIONS
12.1 Sample Size
12.1.1 Dose Escalation
The number of participants will depend on the number of dose cohorts that will be enrolled 
before reaching the MTD. It is anticipated that the study will evaluate three dose levels of PF-
07901801 given in combination with a fixed dose of PLD. On the basis of emerging safety 
and/or clinical activity data, additional dose levels may be added. The size and design of the 
Phase 1 dose escalation phase of the study is consistent with standard 3+3 design with the 
objective of determining the safety of escalating doses of PF-07901801 in combination with 
fixed-dose PLD and establishing PF-07901801 doses for further evaluation in the intended 
participant population. Based on a standard 3+3 design, up to approximately six DLT-
evaluable participants may be enrolled in each dose level cohort during the Phase 1 dose 
escalation portion of the study; a minimum of nine and a maximum of 18 DLT-evaluable 
participants is anticipated.
12.1.2 Expansion Cohort
Phase 2 expansion cohort is planned to evaluate a selected PF-07901801 dose level in 
combination with a fixed dose of PLD. In this hypothesis-generating study, assuming an 
objective response rate of 10% with PLD monotherapy and an alternative of 30%, a power of 
80% and one-sided Type 1 error set at 0.05, the combination will be considered worthy of 
further study if at least six responses are observed in the 25-participant cohort. If the dose level 
combination selected for further Phase 2 is determined to be not optimal or not well tolerated, 
an intermediate dose level, not to exceed the dose levels evaluated in Phase 1, may be 
implemented.
Other secondary endpoints, such as disease control, duration of response, progression-free 
survival and overall survival will be analyzed descriptively.
12.2 Analysis Populations
The following analysis populations are defined for the study:
Safety Population: all participants who received at least one dose of PF-07901801 
DLT-Evaluable Population: all participants in Phase 1 who either experience DLT after at 
least one dose of PF-07901801 or did not experience a DLT and received the full dose of PLD 
and at least two infusions of PF-07901801 and completed safety evaluations during the 28-day 
Cycle 1 DLT period.
PF-07901801 and PLD Concentration Analysis Population: all participants  who received at 
least one dose of PF-07901801 or PLD and have at least one evaluable blood sample for 
analysis collected.
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12.3 Criteria for Evaluation
12.3.1 Safety 
All participants who receive at least dose of PF-07901801 will be included in the safety 
analyses. 
Adverse events, ECGs,   laboratory data will be summarized and reviewed on an ongoing basis 
during the study. All adverse events, ECGs, LVEF assessments and safety laboratory 
abnormalities of potential clinical concern will be described. Safety data will be presented in 
tabular and/or graphical format and summarized descriptively by dose cohort and time where 
appropriate. Absolute value data and changes from baseline data will be summarized as 
appropriate. 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA) and severity of adverse events and laboratory abnormalities will be graded using 
NCI CTCAE v5 as appropriate. Incidence tables of participants with adverse events will be 
presented for all adverse events by maximum severity, serious adverse events, adverse events 
assessed as related to study drug and adverse events resulting in discontinuation of study drug. 
For ECG analyses, the mean of the triplicate ECG parameters will be used as the observation 
for a participant at a nominal time point. Changes in ECG and laboratory measurements will be 
summarized.
Listings of all safety data sorted by dose cohort, participant and assessment date will be 
provided.
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The incidence, onset time and titer of PF-07901801 directed anti-drug antibodies will be 
summarized descriptively. Exploratory analysis may be conducted to evaluate the possible 
effects of anti-drug antibodies on PF-07901801 concentrations, efficacy and safety endpoints.
12.3.4 Disease Control
Clinical efficacy will be evaluated using overall tumor response for participants with 
measurable disease as assessed by the investigators using RECIST v1.1 (Appendix B). 
Duration of response will be calculated for participants who achieve a CR or PR and is defined 
as the time from the date of first documented response (CR or PR) to the date of documented 
progression or death after achieving response. Progression-free survival will be calculated for 
all treated participants from the date of the first dose until the date of progression or death. 
Participants without progression or death will be censored at the date of last non-PD 
assessment. Overall survival will be calculated for all treated participants from the date of the 
first dose until date of death. Participants without death will be censored at the last date the 
participant was known to be alive. Disease control rate is defined as the percentage of 
participants who have achieved CR, PR, or SD lasting at least 12 weeks.
12.3.5 Biomarker and Pharmacodynamics Assessments
The details of biomarker and pharmacodynamic assessments will be described in the SAP or in 
a separate exploratory analysis plan. Results of biomarker and pharmacodynamic analyses will 
be described in the CSR to the extent possible. Due to the exploratory nature of these 
endpoints, the associated data analyses may not be completed at the time of the CSR 
preparation. If results of biomarker and pharmacodynamic analyses are not included in the 
CSR, they may be disseminated to the scientific community to the extent possible through 
presentation at scientific meetings and/or publication in peer-reviewed scientific journals.
12.4 Statistical Methods
Tabular summaries of data will be descriptive in nature (i.e., number of participants [n], mean, 
standard deviation, median, minimum and maximum for continuous variables and n and 
percent for categorical variables). For efficacy parameters, including objective response rate 
and disease control rate, 95% confidence intervals will be presented using the Wilson’s score 
method. Time-to event endpoints such as DOR, PFS, and OS will be evaluated using 
Kaplan-Meier method.
Protocol deviations will be listed. Protocol deviations that might substantially affect efficacy 
analyses will be determined prior to database lock.
A more detailed description of analysis methods will be provided in the SAP to be completed 
prior to the clinical database lock.
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13 SAFETY
Adverse events observed, mentioned on open questioning by a member of the investigator 
team, or spontaneously reported by the participantwill be documented. Adverse events will be 
documented event based. The observation phase for adverse events will start with signing the 
informed consent and will end at the completion of the active reporting period. Planned 
timepoints for all safety assessments are provided in the Study Assessments (Section 10). 
Unscheduled safety measurements may be obtained at any time during the study to assess any 
perceived safety issues.
13.1 Definition of Adverse Events
13.1.1 Adverse Event
An adverse event is any untoward medical occurrence or the worsening of a pre-existing 
medical condition following or during exposure to a pharmaceutical product, whether or not 
considered causally related to the product. Development of new disease lesions or disease 
progression is not considered an adverse event.
All AEs and SAEs occurring in a participant during the active collection period as described in 
Section 13.5.3 will be recorded on the appropriate CRF from the signature of the informed 
consent. All SAEs must be reported on the CT SAE Report Form to Pfizer Safety immediately 
upon awareness and under no circumstance should this exceed 24 hours. A worsening of a 
condition/disease recorded in the medical history is reportable as an AE. Documentation must 
be supported by an entry in the participant’s source medical records. Laboratory abnormalities 
requiring treatment or considered by the investigator to be clinically relevant should be 
reported in the CRF as an AE. Each AE is to be evaluated for duration, severity and causal 
relationship with the IP.
For the purposes of this study, events that are unequivocally due to disease progression should 
not be reported as AEs unless the outcome is fatal within the active collection period. 
Hospitalization due to signs and symptoms of disease progression should not be reported as an 
SAE. If the malignancy has a fatal outcome during the study, the event leading to death must 
be recorded as an AE on the CRF, and as an SAE with CTCAE Grade 5 if it occurs during the 
active collection period. Symptoms of the disease under study/lack of efficacy should not be 
classified as AEs as long as they are within normal day-to-day fluctuations or expected 
progression of the disease.
The development of a new cancer should be regarded as an AE and will generally meet at least 
one of the SAE criteria. New cancers are those that are not the primary reason for study 
treatment and have been identified after the participant’s inclusion in this study. They do not 
include metastases of the original cancer.
13.1.2 Serious Adverse Event 
A serious adverse event is an adverse event occurring during any study at any dose of the 
investigational product(s) that fulfills one or more of the following:
•
Results in death
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•
Is immediately life-threatening (the participant was at risk of death at the time of the event; 
this does not refer to an event which hypothetically might have caused death if it were 
more severe)
•
Requires in-patient hospitalization or prolongation of existing hospitalization
•
Results in persistent or significant disability or incapacity
•
Results in a congenital abnormality or birth defect
•
Is an important medical event that may jeopardize the participant or may require medical 
intervention to prevent one of the outcomes listed above
Medical or scientific judgment should be exercised in deciding whether reporting is 
appropriate in other situations, such as important medical events that may not be immediately 
life threatening or result in death or hospitalization but may jeopardize the participant or may 
require medical or surgical intervention to prevent one of the other outcomes listed in the 
above definition. These should also be considered serious.
Examples of such events include invasive or malignant cancers, intensive treatment in an 
emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do 
not result in hospitalization, or development of drug dependency or drug abuse.
All serious adverse events that occur after any participant has signed informed consent, been 
enrolled, before treatment, during treatment, or within 30 days following the cessation of 
treatment, whether or not they are related to the study intervention, must be recorded on a 
Serious Adverse Event form.
13.2 Clarifications to Serious Adverse Event Reporting
•
Death is an outcome of a serious adverse event and not a serious adverse event in itself. 
When death is an outcome, report the event(s) resulting in death as the serious adverse 
event term (e.g., “pulmonary embolism”). If the cause of death is unknown, report “Death, 
unknown cause” as the serious adverse event term.
•
Pre-planned or elective hospitalizations including social and/or convenience situations 
(e.g., respite care) are excluded from serious adverse event reporting. In addition, 
emergency room visits and admission under 23-hour observation are excluded from serious 
adverse event reporting; however, such events should still be reported on the appropriate 
adverse event eCRF page.
•
An isolated laboratory abnormality is not reportable as a serious adverse event unless the 
investigator assesses that the event meets the standard ICH criteria for a serious adverse 
event.
13.3 Assessment of Causality
The relationship of each adverse event to administration of the study drug(s) will be assessed 
by the investigator after careful consideration of all relevant factors such as (but not limited to) 
the underlying study indication, co-existing disease, concomitant medication, relevant history, 
pattern of the adverse event, temporal relationship to receipt of the study medication(s) and de-
challenge or re-challenge.
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Study drug or study treatment refers to intravenously-administered PLD and intravenously-
administered PF-07901801. The assessment of relationship to study drug or study treatment 
will be done for each drug separately. If the investigator feels such a distinction cannot be 
made, the assessment will be based on the combination of the two drugs.
The assessment of causality is based on the question of whether there was a reasonable causal 
relationship to the study drug in question according to the following guidelines:
RELATED: there is a reasonable possibility that the study treatment caused the event; one or 
more of the following criteria apply:
•
The event follows a reasonable temporal sequence from administration of study treatment
•
The event could not be reasonably attributed to the known characteristics of the 
participant’s clinical state, environment or toxic factors or other modes of therapy 
administered to the participant
•
The event follows a known pattern of response to study treatment
•
The event disappears or decreases on cessation or reduction in dose of the study treatment. 
In some situations, an adverse event will not disappear or decrease in intensity upon 
discontinuation of the study treatment despite other clear indications of relatedness
UNRELATED: there is no reasonable possibility that the study treatment caused the event; one 
or more of the following criteria apply: 
•
The event does not follow a reasonable temporal sequence from administration of study 
treatment 
•
The event could be reasonably attributed to known characteristics of the participant’s 
clinical state, concurrent illness, environment or toxic factor or other therapies administered 
to the participant
•
The event does not follow a known pattern of response to study treatment
•
The event does not disappear or decrease on cessation or reduction in dose of the study 
treatment, and it does not reappear or worsen when the study treatment is re-administered
•
There is a clear alternative explanation
13.4 Assessment of Severity
The severity rating of an adverse event refers to its intensity. The severity of each adverse 
event will be categorized using the NCI CTCAE v5. For any term that is not specifically listed 
in the CTCAE scale, intensity should be assigned a grade of 1 through 5 using the following 
CTCAE guidelines:
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living
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Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting self-care activities of 
daily living
Grade 4: Life-threatening consequences; urgent intervention indicated
Grade 5: Death related to adverse event
It is important to distinguish between serious adverse events and severe adverse events. 
Severity is a measure of intensity whereas seriousness is defined by the criteria under 
Section 13.1.2. An adverse event of severe intensity may not be considered a serious adverse 
event.
13.5 Action Taken
Any action with study treatment to resolve the adverse event is to be documented using the 
categories listed below. The study drug action should be recorded separately for each 
component as detailed in the eCRF.
•
Drug withdrawn
•
Drug interrupted
•
Dose reduced
•
Dose not changed
•
Not applicable
•
Unknown
13.5.1 Other Specific Treatments of Adverse Event
•
None
•
Remedial drug therapy
•
Other
13.5.2 Outcome of Adverse Event
The outcome of the adverse event is to be documented as follows:
•
Recovered / resolved
•
Recovering / resolving
•
Recovered / resolved with sequelae
•
Not recovered / not resolved
•
Fatal
•
Unknown
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13.5.3 Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection period”) 
for each participant begins from the time the participant provides informed-consent, which is 
obtained before undergoing any study-related procedure and/or receiving study intervention, 
through and including a minimum of 30 calendar days after the last administration of the study 
intervention.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant permanently discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE reported 
using the CT SAE Report Form.
Investigators are not obligated to actively seek information on AEs or SAEs after the 
participant has concluded study participation. However, if the investigator learns of any SAE, 
including a death, at any time after a participant has completed the study, and they consider the 
event to be reasonably related to the study intervention, the investigator must promptly report 
the SAE to Pfizer using the CT SAE Report Form.
13.5.4 Documentation
All AEs (serious and non-serious) occurring within the period of observation for the study 
must be documented in the CRF with the following information, where appropriate. (The 
period of observation for the study is described in Section 13.5.3).
•
AE name or term
•
When the AE first occurred (start date)
•
When the AE stopped (stop date or an indication of “ongoing”)
•
Severity of the AE
•
Seriousness (hospitalization, death, etc.)
•
Actions taken
•
Outcome
•
Investigator opinion regarding the AE relationship to the IP(s)
All nonserious AEs and SAEs occurring in a participant during the active collection period 
which begins after obtaining informed consent as described in Section 13.5.3, will be recorded 
on the AE section of the CRF.
The investigator or designee is to record on the CRF all directly observed and all 
spontaneously reported AEs and SAEs reported by the participant.
The investigator must record his or her reasoning for this decision in the participant’s medical 
record and as a comment on the CRF.
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Reporting of AEs and SAEs for participants who fail screening are subject to the CRF 
requirements as described in Section 13.5.3.
As part of ongoing safety reviews conducted by the sponsor, any nonserious AE that is 
determined by the sponsor to be serious will be reported by the sponsor as an SAE. To assist in 
the determination of case seriousness, further information may be requested from the 
investigator to provide clarity and understanding of the event in the context of the clinical 
study.
If a participant begins a new anti-cancer therapy, the recording period for nonserious AEs ends 
at the time the new treatment is started; however, SAEs must continue to be recorded on the 
CRF during the above indicated active collection period. Note that a switch to a commercially 
available version of the study intervention is considered as a new anti-cancer therapy for the 
purposes of SAE reporting.
13.5.5 Follow-Up
Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the investigator.
If a participant is lost to follow-up, this should be captured accordingly within the adverse 
event eCRF and on the follow-up serious adverse event report.
When a clinically important AE remains ongoing at the end of the active collection period, 
follow-up by the investigator continues until the AE or SAE or its sequelae resolve or stabilize 
at a level acceptable to the investigator and Pfizer concurs with that assessment.
After the initial AE or SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, or 
the participant is lost to follow up.
In general, follow up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of possible 
causality. Any information relevant to the event, such as concomitant medications and 
illnesses, must be provided. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.
All findings relevant to the final outcome of an AE must be reported in the participant’s 
medical record and recorded on the eCRF page.
New and ongoing treatment-related serious adverse events should be followed beyond the 30-
day Safety Follow-Up Visit. If the participant dies, this should be captured as the outcome of 
the adverse event unless no link between the adverse event and the participant death can be 
established, in which case the adverse event will be marked as ongoing and the death will be 
reported as a separate event. In the case of a participant death, a summary of available autopsy 
findings must be submitted as soon as possible to Pfizer Safety.
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13.5.6 Notification
Serious Adverse Events
The investigator or designee must report all SAEs (related and unrelated) promptly to Pfizer 
Safety within 24 hours of the knowledge of the occurrence.
To report the SAE, complete the CT SAE form electronically in the Pfizer SAE Submission 
Assistant (PSSA) tool. When the form is completed, Pfizer Safety personnel will be notified 
electronically. If the event meets serious criteria and it is not possible to access the PSSA tool, 
then fax the completed paper CT SAE form to Pfizer Safety within 24 hours of awareness. 
When the PSSA tool becomes available, the SAE information must be entered within 24 hours 
of the PSSA system becoming available.
At the time of first notification, the investigator or designee should provide the following 
information, if available:
•
Protocol number
•
Reporter (study site and investigator)
•
Participant’s study number
•
Participant’s year of birth
•
Participant’s gender
•
Date of first dose of IP(s)
•
Date of last dose of IP(s), if applicable
•
AE term
•
Date of occurrence of the event
•
A brief description of the event, outcome to date, and any actions taken
•
The seriousness criteria(on) that were met
•
Concomitant medication at onset of the event
•
Relevant medical history information
•
Relevant laboratory test findings
•
Investigator’s opinion of the relationship to IP(s). (“Is there a reasonable possibility that 
the IP caused the SAE? Yes or No?”)
It should be noted that the CT SAE Report Form for reporting of SAE information is not the 
same as the AE page of the CRF. When the same data are collected, the forms must be 
completed in a consistent manner. AEs should be recorded using concise medical terminology 
and the same AE term should be used on both the CRF and the CT SAE Report Form for 
reporting of SAE information.
13.5.7 Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
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sponsor will comply with country-specific regulatory requirements relating to safety reporting 
to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary.
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements.
13.6 Adverse Events of Special Interest
N/A
13.7 Lack of Efficacy
The investigator must report signs, symptoms, and/or clinical sequelae resulting from lack of 
efficacy. Lack of efficacy or failure of expected pharmacological action is reportable to Pfizer 
Safety only if associated with an SAE.
13.8 Environmental Exposure,  Exposure during Pregnancy, or Breastfeeding, and 
Occupational Exposure
Environmental exposure, occurs when a person not enrolled in the study as a participant
receives unplanned direct contact with or exposure to the study intervention. Such exposure 
may or may not lead to the occurrence of an AE or SAE. Persons at risk for environmental 
exposure include healthcare providers, family members and others who may be exposed. An 
environmental exposure may include Exposure During Pregnancy (EDP), Exposure During 
Breastfeeding (EDB) and occupational exposure. Any such exposure to the study intervention 
under study are reportable to Pfizer Safety within 24 hours of investigator awareness.
13.8.1 Exposure During Pregnancy (EDP) 
An EDP occurs if:
•
A female participant is found to be pregnant while receiving or after discontinuing 
study intervention for at least 45 days after last dose of PF-07901801 AND for 
combination therapy with PLD, during and for 6 months after treatment which 
corresponds to the time needed to eliminate any reproductive safety risk of the study 
intervention(s).
•
A female nonparticipant is found to be pregnant while being exposed or having been 
exposed to study intervention because of environmental exposure. Below are examples 
of environmental EDP:
•
A female family member or healthcare provider reports that she is pregnant 
after having been exposed to the study intervention by ingestion, inhalation or 
skin contact.
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•
A male family member or healthcare provider who has been exposed to the 
study intervention by ingestion, inhalation or skin contact then inseminates his 
female partner prior to or around the time of conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy).
•
If EDP occurs in a participant or participant’s partner, the investigator must report 
this information to Pfizer Safety through PSSA, on the CT SAE Report Form and 
an EDP Supplemental Form regardless of whether an SAE has occurred. Details of 
the pregnancy will be collected after the start of study intervention until 45 days 
after the last dose of PF-07901801 and for combination therapy with PLD, during 
and for 6 months after treatment.
•
If EDP occurs in the setting of environmental exposure, the investigator must 
report information to Pfizer Safety through PSSA using the CT SAE Report Form 
and EDP Supplemental Form. Since the exposure information does not pertain to 
the participant enrolled in the study, the information is not recorded on a CRF, 
however, a copy of the completed CT SAE Report Form is maintained in the 
investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for all 
EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural integrity 
of the terminated fetus should be assessed by gross visual inspection (unless pre-procedure test 
findings are conclusive for a congenital anomaly and the findings are reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal demise, 
neonatal death or congenital anomaly), the investigator should follow the procedures for 
reporting SAEs. Additional information about pregnancy outcomes that are reported to Pfizer 
Safety as SAEs follows:
•
Spontaneous abortion including miscarriage, and missed abortion should be 
reported as an SAE
•
Neonatal deaths that occur within 1 month of birth should be reported, without 
regard to causality, as SAEs. In addition, infant deaths after 1 month should be 
reported as SAEs when the investigator assesses the infant death as related or 
possibly related to exposure to the study intervention.
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Additional information regarding the EDP may be requested by the sponsor. Further follow-up 
of birth outcomes will be handled on a case-by-case basis (eg, follow-up on preterm infants to 
identify developmental delays). In the case of paternal exposure, the investigator will provide 
the participant with the Pregnant Partner Release of Information Form (PPRIF) to deliver to his 
partner. The investigator must document in the source documents that the participant was given 
the Pregnant Partner Release of Information Form to provide to his partner.
13.8.2 Exposure During Breastfeeding (EDB)
An EDB occurs if:
A female participant is found to be breastfeeding while receiving or after discontinuing study 
intervention until 45 days after the last dose of PF-07901801 and for combination therapy with 
PLD, during and for 6 months after treatment.
A female non-participant is found to be breastfeeding while being exposed or having been 
exposed to study intervention (ie, environmental exposure). An example of environmental 
EDB is a female family member or healthcare provider who reports that she is breastfeeding 
after having been exposed to the study intervention by ingestion, inhalation or skin contact.
The investigator must report EDB to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The information must be reported 
through PSSA. When EDB occurs in the setting of environmental exposure, the exposure 
information does not pertain to the participant enrolled in the study, so the information is not 
recorded on a CRF. However, a copy of the completed CT SAE Report Form (extracted from 
PSSA) is maintained in the investigator site file.
An EDB report is not created when a Pfizer drug specifically approved for use in breastfeeding 
women (eg, vitamins) is administered in accordance with authorized use. However, if the 
infant experiences an SAE associated with such a drug, the SAE is reported together with the 
EDB.
13.8.3 Occupational Exposure
The investigator must report any instance of occupational exposure to Pfizer Safety within 24 
hours of the investigator’s awareness using the CT SAE Report Form regardless of whether 
there is an associated SAE. Since the information about the occupational exposure does not 
pertain to a participant enrolled in the study, the information is not recorded on a CRF;
however, a copy of the completed CT SAE Report Form (extracted from PSSA) must be 
maintained in the investigator site file.
13.8.4 Cardiovascular and Death Events
Not Applicable
13.8.5 Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable
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13.9 Medication Error
Medication errors may result from the administration or consumption of the study intervention 
by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Medication errors include:
•
Medication errors involving participant exposure to the study intervention
•
Potential medication errors or uses outside of what is foreseen in the protocol that do or 
do not involve the study participant
•
The administration of expired study intervention
•
The administration of an incorrect study intervention
•
The administration of an incorrect dosage
•
The administration of study intervention that has undergone temperature excursion 
from the specified storage range, unless it is determined by the sponsor that the study 
intervention under question is acceptable for use.
In the event of a medication dosing error, the sponsor should be notified within 24 hours.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error and associated AE(s), serious and non-serious, are recorded 
on the AE page of the CRF. Medication errors should be reported to Pfizer Safety within 24 
hours through PSSA only when associated with an SAE.
13.10 Laboratory Abnormalities
To the extent possible, all laboratory abnormalities observed during the course of the study will 
be included under a reported adverse event term describing a clinical syndrome (e.g., elevated 
blood urea nitrogen and creatinine in the setting of an adverse event of “renal failure”). In these 
cases (e.g., an adverse event of renal failure), the laboratory abnormality itself (e.g., elevated 
creatinine) does not need to be recorded as an adverse event.
If a laboratory abnormality cannot be reported as a clinical syndrome, AND if the laboratory 
abnormality results in a therapeutic intervention (i.e., concomitant medication or therapy), is a 
dose-limiting toxicity or is judged by the investigator to be of other particular clinical 
relevance, then the laboratory abnormality should be reported as an adverse event. Laboratory 
Abnormalities requiring treatment or considered by the investigator to be clinically-relevant 
should be reported in the CRF as an AE.
See APPENDIX D for suggested actions and follow-up assessments in the event of potential 
drug induced liver injury.
See APPENDIX E for instructions for laboratory testing to monitor kidney function and 
reporting laboratory test abnormalities.
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Participants experiencing adverse events or clinically-significant laboratory abnormalities will 
be assessed and appropriate evaluations performed until all parameters have returned to 
baseline levels or are consistent with the participant’s then-current physical condition. 
13.11 Sponsor Safety Review
The medical monitor or designee will be responsible for the ongoing review and evaluation of 
safety throughout the study (this includes all laboratory, ECG and echocardiogram/MUGA 
data as well as all adverse events).
13.12 Overview of Safety Monitoring
Throughout the study, investigators, site staff and the study sponsor will meet regularly to 
review the status of all active participants on study. During the dose escalation portion of the 
study, a regularly scheduled safety and information call will be held with participating 
investigators and site staff to discuss safety, review any questions, provide updates and to share 
information across sites. At the completion of each dose escalation cohort, safety data will be 
summarized and presented for discussion with all investigators for the purpose of determining 
whether the observed safety in each cohort warrants escalation to the next higher dose level or 
whether an alternate dose level or other action should be considered.
During the dose expansion portion of the study, these regularly-scheduled safety and 
information calls will continue; the calls will initially be held regularly although ad hoc
meetings may be held as necessary to review specific safety or other issues that might arise 
during the course of the study. As the study progresses, the frequency of these safety and 
information calls may be adjusted to reflect need on the basis of safety observations observed, 
the rate of enrollment and investigator or sponsor request or need.
14 ETHICAL AND ADMINISTRATIVE CONSIDERATIONS
This study will be conducted in accordance with applicable national and local regulations and 
guidelines, Good Clinical Practice (GCP), including ICH guidelines (Integrated Addendum To 
ICH E6[R1]: Guideline For Good Clinical Practice, E6[R2], Current Step 4 version [2016]), 
the National Statement on Ethical Conduct in Human Research 2007, and The Declaration of 
Helsinki (Brazil, 2013). 
14.1 Regulatory Authority Approvals
The sponsor or designee will submit the study protocol plus all relevant study documents to 
applicable regulatory agencies for approval , as appropriate, before the study start. No 
participant will be admitted to the study until regulatory submissions are complete and 
approvals, where appropriate, have been received.
Each investigator must complete a Form FDA 1572 or equivalent and provide the completed 
form according to written instructions to the sponsor (or designee). Each investigator must 
submit to the sponsor (or designee) financial disclosure information according to national law 
and/or local regulations.
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Data generated in the US will be handled in accordance with the Health Information Portability 
and Accountability Act (HIPAA). The study will be registered at www.clinicaltrials.gov using 
the Protocol Registration System.
14.2 Institutional Review Board 
This protocol and any material to be provided to the participant (such as advertisements, 
patient information sheets, informed consent document or descriptions of the study used to 
obtain informed consent) will be submitted by the investigator to an IRB. This also applies to 
protocol amendments.
The sponsor will supply relevant data for the investigator to submit the study protocol and 
additional study documents to the IRB. The principal investigator will submit the study 
protocol for review and approval by an IRB, according to national law and/or local regulations, 
and will provide the IRB with all appropriate materials.
Verification of the IRB’s unconditional approval of the study protocol and the written ICF will 
be transmitted to the sponsor. This approval must refer to the study by exact study protocol title 
and number, identify the documents reviewed, and state the date of the review.
No patient will be admitted to the study until appropriate IRB approval of the study protocol 
and the informed consent document has been received, the investigator has obtained the signed 
and dated ICF, and the sponsor is notified.
The principal investigator will submit appropriate reports on the progress of the study to the 
IRB at least annually in accordance with applicable national law and/or local regulations and in 
agreement with the policy established by the IRB and sponsor.
The IRB must be informed by the principal investigator of all subsequent study protocol 
amendments and of serious adverse events or SUSARs occurring during the study that are 
likely to affect the safety of the participants or the conduct of the study.
14.3 Confidentiality of Information
The investigator must ensure that participants’ anonymity is strictly maintained and that their 
identities are protected from unauthorized parties. Only participant initials and an identification 
code (i.e., not names) should be recorded on any form submitted to the sponsor and the IRB. 
The investigator must keep logs on screened and enrolled participants. In addition, the 
investigator must have a list where the identity of all treated participants can be found.
The investigator agrees that all information received from the sponsor, including, but not 
limited to, the Investigator’s Brochure, this protocol, eCRFs, the protocol-specified treatment, 
and any other study information, remain the sole and exclusive property of the sponsor during 
the conduct of the study and thereafter. This information is not to be disclosed to any third 
party (except employees or agents directly involved in the conduct of the study or as required 
by law) without prior written consent from the sponsor. The investigator further agrees to take 
all reasonable precautions to prevent the disclosure by any employee or agent of the study 
center to any third party or otherwise into the public domain. The investigator shall be under 
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additional obligations related to non-disclosure confidential information and the handling of 
intellectual property as set forth in the Clinical Trial Agreement.
14.4 Patient Informed Consent
All information about the clinical study, including the participant information and the informed 
consent form, is prepared and used for the protection of the human rights of the participant 
according to ICH GCP guidelines and the Declaration of Helsinki.
It is the responsibility of the investigator to obtain signed informed consent forms from each 
participant participating in this study after adequate explanation of the aims, methods, 
objectives, and potential hazards of the study and before undertaking any study-related 
procedures.
The informed consent form, prepared by the investigator with the assistance of the sponsor, 
must be approved along with the study protocol by the IRB and be acceptable to the sponsor.
The participant must be provided with the patient information and informed consent form 
consistent with the study protocol version used and approved by the relevant IRB. The 
informed consent form must be in a language fully-comprehensible to the prospective 
participant. Participants (and/or relatives, guardians, or legal representatives, if necessary) must 
be given sufficient time and opportunity to inquire about the details of the study and to discuss 
with the investigator and decide on their participation in the study. The participant and the 
person explaining about the study and with whom they discuss the informed consent will sign 
and date the informed consent form. A copy of the signed informed consent form will be 
retained by the participant and the original will be filed in the investigator file unless otherwise 
agreed. The consenting process will be documented.
14.5 Study Monitoring
On behalf of the sponsor, a clinical research organization monitor will contact and visit the 
investigator at the study center as necessary before the entry of the first participant and at 
predetermined appropriate intervals during the study until after the last participant has 
completed. The clinical research organization will use centralized remote monitoring and on-
site monitoring activities including source document verification to support and oversee 
activities being undertaken at the study center. The monitor will also perform a study closure 
visit.
In accordance with ICH GCP guidelines, the investigator must ensure provision of sufficient 
time, reasonable space, and adequate qualified personnel for the monitoring visits. The visits 
are for the purpose of verifying adherence to the study protocol and the completeness, 
consistency, and accuracy of data entered on the eCRF and other documents.
The investigator will make all source data (i.e, the various study records, the eCRFs, laboratory 
test reports, other participant records, drug accountability forms, and other pertinent data) 
available for the monitor and allow access to them throughout the entire study period. 
Monitoring is done by comparing the relevant site records of the participants with the entries 
on the eCRF (i.e., source data verification). It is the monitor’s responsibility to verify the 
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adherence to the study protocol and the completeness, consistency, and accuracy of the data 
recorded on the eCRFs.
By agreeing to participate in the study, the investigator agrees to cooperate with the monitor to 
ensure that any problems detected in the course of the monitoring visits are resolved. Contact 
information for the study monitor is located in the investigator file. Representatives from the 
sponsor may also contact and visit the investigators and monitor data during the study.
14.6 Clinical Supplies
The principal investigator will be responsible for the dispensing, inventory and accountability 
of all clinical supplies, ensuring that accepted medical and pharmaceutical practices are 
followed. An accurate and timely accountability record of the disposition of all clinical 
supplies must be maintained. The supplies and inventory record must be made available for 
inspection by the sponsor or the designated sponsor’s representative upon request. Under no 
circumstances will the principal investigator allow the investigational product to be used other
than as directed by this protocol.
14.7 Electronic Case Report Form 
The data will be collected using an electronic data capture (EDC) system by remote data entry 
on eCRFs and by agreeing to participate in the study, the investigator agrees to maintain 
accurate eCRF and source documents as part of the case history for each participant who 
participates in the study. Sites will receive training on the EDC system. All users will be 
supplied with unique login credentials.
Before study start, the investigator will prepare a list showing the signature and handwritten 
initials of all individuals authorized to make or change entries on eCRFs. This “study center 
personnel and delegation list” must be kept current throughout the study.
For each participant enrolled, an eCRF must be completed, reviewed, signed and dated by the 
principal investigator or Co-investigator. Data entry into the CRF should be completed within a 
reasonable time period after data collection, generally on the order of approximately two 
weeks. This also applies to records for those participants who fail to complete the study. If a 
participant withdraws from the study, the reason must be noted on the eCRF. If a participant is 
withdrawn from the study because of a treatment-limiting adverse event, thorough efforts 
should be made to clearly document the outcome.
All laboratory data and investigator observations on the results and any other clinically 
significant test results must be documented on eCRFs. Full information regarding EDC and 
completing eCRFs is included in the investigator files. All questions or comments related to 
electronic data capture should be directed to the assigned study monitor.
14.8 Study Termination and Site Closure
Both the sponsor and the investigator reserve the right to terminate the study at any time. 
Should this be necessary, both parties will arrange discontinuation procedures. In terminating 
the study, the sponsor and the investigator will ensure that adequate consideration is given to 
the protection of the participants’ interests.
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The sponsor reserves the right to discontinue the study at any time for medical or 
administrative reasons. When feasible, a 30-day written notification will be given.
The entire study will be stopped if:
•
The protocol-specified treatment is considered too toxic to continue the study
•
Evidence has emerged that, in the opinion of the sponsor or the investigator(s), makes 
the continuation of the study unnecessary or unethical
•
The stated objectives of the study are achieved
•
The sponsor discontinues the development of study drug
Regardless of the reason for termination, all data available for the participant at the time of 
discontinuation of follow-up must be recorded on the eCRF. All reasons for discontinuation of 
treatment must be documented. In terminating the study, the investigator will ensure that 
adequate consideration is given to the protection of the participants’ interests.
14.9 Modification of the Study Protocol
Protocol amendments, except when necessary to eliminate an immediate hazard to participants, 
must be made only with the prior approval of the sponsor. Agreement from the investigator 
must be obtained for all protocol amendments and amendments to the informed consent 
document. The IRB must be informed of all amendments and give approval before their 
implementation. The sponsor will submit any study protocol amendments to the concerned 
regulatory authorities for approval and keep the investigator(s) updated as detailed in the ICH 
GCP guidelines.
14.10 Retention of Study Documents
The study site will maintain a study file, which should contain, at minimum, the IB, the 
protocol and any amendments, drug accountability records, correspondence with the IRB and 
the sponsor, and other study-related documents.
The investigator agrees to keep records and those documents that include (but are not limited 
to) the identification of all participating participants, medical records, study-specific source 
documents, source worksheets, all original signed and dated ICFs, copies of all eCRFs, query 
responses, and detailed records of drug disposition to enable evaluations or audits from 
regulatory authorities and the sponsor or its designees.
The investigator shall retain records required to be maintained for a period of 5 years after the 
date a marketing application in an ICH region is approved for the drug for the indication for 
which it is being investigated or, if no application is to be filed or if the application is not 
approved for such indication, until at least 5 years after the investigation is discontinued. 
However, these documents should be retained for a longer period if required by the applicable 
regulatory requirement(s) or if needed by the sponsor. In addition, the investigator must make 
provision for the participants’ medical records to be kept for the same period of time.
No data should be destroyed without the agreement of the sponsor. Should the investigator 
wish to assign the study records to another party or move them to another location, the sponsor 
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must be notified in writing of the new responsible person and/or the new location. The sponsor 
will inform the investigator, in writing, when the study-related records are no longer needed.
Participants’ medical records and other original data will be archived in accordance with the 
archiving regulations or facilities of the investigational site.
14.11 Clinical Study Report
A clinical study report will be prepared under the responsibility and supervision of the sponsor 
and signed by a sponsor representative, thereby indicating their agreement with the analyses, 
results, and conclusions of the clinical study report.
14.12 Study Publication
The conditions regulating dissemination of the information derived from this study are 
described in the Clinical Trial Agreement.
14.13 Quality Assurance Audits
An audit visit to clinical centers may be conducted by a quality assurance auditor appointed by 
the sponsor. The purpose of an audit, which is independent of and separate from routine 
monitoring or quality control functions, is to evaluate study conduct and compliance with the 
protocol, standard operating procedures, ICH GCP and the applicable regulatory requirements. 
The investigator and the sponsor may also be subject to an inspection by the US Food and 
Drug Administration (FDA), Health Canada, European regulatory authorities or other 
applicable regulatory authorities at any time.
The auditor and regulatory authorities will require authority from the investigator to have direct 
access to the participants’ medical records. It is important that the investigator(s) and their staff 
cooperate with the auditor or regulatory authorities during this audit or inspection.
14.14 Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT/CTIS, and/or 
www.pfizer.com, and other public registries and websites in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs. 
In all cases, study results are reported by Pfizer in an objective, accurate, balanced and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in participants) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted. These results are 
submitted for posting in accordance with the format and timelines set forth by US law. 
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EudraCT/CTIS
Pfizer posts clinical trial results on EudraCT/CTIS for Pfizer-sponsored interventional studies 
in accordance with the format and timelines set forth by EU requirements. 
www.pfizer.com
Pfizer posts CSR synopses and plain-language study results summaries on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are 
posted to www.clinicaltrials.gov. CSR synopses will have personally-identifiable information 
anonymized. 
Documents within Marketing Authorization Applications 
Pfizer complies with applicable local laws/regulations to publish clinical documents included 
in marketing applications. Clinical documents include summary documents and CSRs 
including the protocol and protocol amendments, sample CRFs, and SAPs. Clinical documents 
will have personally identifiable information anonymized. 
Data Sharing 
Pfizer provides researchers secure access to participant-level data or full clinical study reports 
for the purposes of “bona-fide scientific research” that contributes to the scientific 
understanding of the disease, target or compound class. Pfizer will make data available from 
these trials 24 months after study completion. Participant-level data will be anonymized in 
accordance with applicable privacy laws and regulations. Clinical study reports will have 
personally-identifiable information anonymized.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not be 
provided to applicants with significant conflicts of interest, including individuals requesting 
access for commercial/competitive or legal purposes.
14.15 Finance and Insurance 
Details on finance and insurance will be provided in a separate agreement between the 
investigator and the sponsor.
14.16 Retention of Biological Specimens
Biological specimens collected during the course of this study may be used for purposes 
related to this research. Specimens will be stored until the sponsor has determined that 
specimens are no longer needed and the decision has been made that none of the samples need 
to be re-analyzed. Identifiable specimens can be destroyed at any time at the request of the 
participant.
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41. ten Bokkel Huinink W, Gore M, Carmichael J et al. Topotecan versus paclitaxel for the 
treatment of recurrent epithelial ovarian cancer. J Clin Oncol. 1997; 15(6):2183–93.
42. Inker LA, Eneanya ND, Coresh J et al. New Creatinine-and Cystatin C- based Equations 
to Estimate GFR without Race. N Engl J Med. 2021; 385(19):1737-49.
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16 APPENDIX A
ECOG Performance Status Assessment Scale
ECOG 
Performance 
Status
Description
0
Fully active, able to carry on all pre-disease performance without 
restriction.
1
Restricted in physically strenuous activity but ambulatory and able to 
carry out work of a light or sedentary nature, e.g., light house work, 
office work.
2
Ambulatory and capable of all selfcare but unable to carry out any work 
activities. Up and about more than 50% of waking hours.
3
Capable of only limited selfcare, confined to bed or chair more than 50% 
of waking hours.
4
Completely disabled. Cannot carry on selfcare. Totally confined to bed 
or chair.
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17 APPENDIX B
Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1
RECIST guidelines (Version 1.1) are described in Eisenhauer (2009) and at 
https://recist.eortc.org/recist-1-1-2/; a short summary is given below.
Measurable Disease
Tumor lesions: measurable lesions are defined as those that can be accurately measured in at 
least one dimension (longest diameter to be recorded) with the following:
•
A minimum size of 10 mm by CT scan (CT scan thickness no greater than 5 mm);
•
A minimum size of 10 mm caliper measurement by clinical exam (lesions that cannot 
be accurately measured with calipers should be recorded as nonmeasurable);
•
A minimum size of 20 mm by chest X-ray.
All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters).
Measurable Disease
Tumor lesions: measurable lesions are defined as those that can be accurately measured in at 
least one dimension (longest diameter to be recorded) with the following:
•
A minimum size of 10 mm by CT scan (CT scan thickness no greater than 5 mm);
•
A minimum size of 10 mm caliper measurement by clinical exam (lesions that cannot 
be accurately measured with calipers should be recorded as nonmeasurable);
•
A minimum size of 20 mm by chest X-ray.
All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters).
Malignant lymph nodes: to be considered pathologically enlarged and measurable, a lymph 
node must be ≥15 mm in short axis when assessed by CT scan (CT scan slice thickness 
recommended to be not greater than 5 mm). At baseline and in follow up, only the short axis 
will be measured and followed.
Non-measurable Disease
All other lesions (or sites of disease), including small lesions (longest diameter < 10 mm or 
pathological lymph nodes with ≥ 10 to < 15 mm short axis), as well as truly non-measurable 
lesions, are considered non-measurable disease. Lesions considered truly non-measurable 
include leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast 
disease, lymphangitic involvement of skin and lung, and abdominal masses/abdominal 
organomegaly identified by physical exam that is not measurable by reproducible imaging 
techniques.
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Bone Lesions
Bone lesions, cystic lesion, and lesions previously treated with local therapy require particular 
comment. Bone scan, PET scan or plain films are not considered adequate imaging techniques 
to measure bone lesions. However, these techniques can be used to confirm the presence or 
disappearance of bone lesions.
Lytic bone lesions or mixed lytic-blastic lesions with identifiable soft tissue components that 
can be evaluated by cross-sectional imaging techniques such as CT or MRI can be considered 
as measurable lesions if the soft tissue component meets the definition of measurability 
described above. Blastic bone lesions are non-measurable.
Cystic Lesions
Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) because they are, by 
definition, simple cysts.
Cystic lesions thought to represent cystic metastases can be considered as measurable lesions if 
they meet the definition of measurability described above. However, if non-cystic lesions are 
present in the same patient, these are preferred as target lesions.
Lesions with Prior Local Treatment
Tumor lesions situated in a previous irradiated area or in an area subjected to other 
locoregional therapy are usually not considered measurable unless there has been demonstrated 
progression in the lesion.
Target Lesions
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, 
representative of all involved organs, should be identified as target lesions and recorded and 
measured at baseline. Target lesions should be selected on the basis of their size (lesions with 
the longest diameter) and their suitability for accurate repeated measurements (either by 
imaging techniques or clinically). A sum of the longest diameter (LD) for all target lesions will 
be calculated and reported as the baseline sum LD. The baseline sum LD will be used as 
reference by which to characterize the overall tumor response.
Non-Target Lesions
RECIST criteria require unequivocal quantification of the changes in tumor size for adequate 
interpretation of the sum of target lesions. Consequently, when the boundaries of the primary 
are difficult to delineate, this tumor should not be considered a target lesion.
Guidelines for Evaluation of Measurable Disease
The same method of assessment and the same technique should be used to characterize each 
identified and reported lesion at baseline and during follow up. Imaging-based evaluation is 
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preferred to evaluation by clinical examination when both methods have been used to assess 
the antitumor effect of a treatment.
Evaluation of Target Lesions
Complete Response
Disappearance of all target lesions. Any pathological lymph nodes 
(whether target or non-target) must have reduction in short axis to < 10 
mm.
Partial Response
At least a 30% decrease in the sum of the LD of target lesions, taking as 
reference the baseline sum LD.
Stable Disease
Neither sufficient shrinkage to qualify for partial response nor sufficient 
increase to qualify for PD, taking as reference the smallest sum LD 
since the treatment started.
Progressive Disease
At least a 20% increase in the sum of the LD of target lesions, taking as 
reference the smallest sum on study (this includes the baseline sum if 
that is the smallest on study). In addition to the relative increase of 20%, 
the sum must also demonstrate an absolute increase of at least 5 mm. 
The appearance of one or more new lesions is also considered 
progression.
Evaluation of Non-Target Lesions
Complete Response
Disappearance of all non-target lesions and normalization of tumor 
marker level.
Stable Disease/
Incomplete Response
Persistence of one or more non-target lesion(s) or/and maintenance of 
tumor marker level above the normal limits.
Progressive Disease
Appearance of one or more new lesions and/or unequivocal 
progression of existing non-target lesions.
If tumor markers are initially above the institutional ULN, they must normalize for a patient to 
be considered a complete responder.
Evaluation of Best Overall Response
The best overall response is the best response recorded from the start of the treatment until 
disease progression/recurrence (taking as reference for PD the smallest measurements recorded 
since the treatment started). The patient’s best response assignment will depend on the 
achievement of both measurement and confirmation criteria.
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Timepoint Response
A response assessment will occur at the protocol-specified timepoints. The tables below 
provide a summary of the overall response status calculation at each timepoint for patients who 
have measurable and non-measurable disease (non-target disease only).
Timepoint Response: Patients with Target (± Non-Target) Disease
Target Lesions
Non-target Lesions
New Lesions
Overall Response
CR
CR
No
CR
CR
Non-CR/non-PD
No
PR
CR
Not evaluated
No
PR
PR
Non-PD or not evaluated
No
PR
SD
Non-PD or not evaluated
No
SD
Not Evaluated
Non-PD
No
NE
PD
Any
Yes or No
PD
Any
PD
Yes or No
PD
Any
Any
Yes
PD
CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease; NE, Not evaluable.
Evaluation of Best Overall Response When Confirmation of CR and PR Required
Overall 
Response
First 
Timepoint
Overall Response
Subsequent 
Timepoint
Best Overall Response
CR
CR
CR
CR
PR
SD, PD or PRa
CR
SD
SD provided minimum criteria for SD duration met, 
otherwise, PD
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Overall 
Response
First 
Timepoint
Overall Response
Subsequent 
Timepoint
Best Overall Response
CR
PD
SD provided minimum criteria for SD duration met, 
otherwise, PD
CR
NE
SD provided minimum criteria for SD duration met, 
otherwise, NE
PR
CR
PR
PR
PR
PR
PR
SD
SD
PR
PD
SD provided minimum criteria for SD duration met, 
otherwise, PD
PR
NE
SD provided minimum criteria for SD duration met, 
otherwise, NE
NE
NE
NE
a.
If a CR is truly met at first timepoint, then any disease seen at a subsequent timepoint, even disease meeting 
PR criteria relative to baseline, makes this disease PD at that point (since disease must have reappeared after 
CR). Best response would depend on whether minimum duration for SD was met. However sometimes ‘CR’ 
may be claimed when subsequent scans suggest small lesions were likely still present and in fact the patient had 
PR, not CR at the first time point. Under these circumstances, the original CR should be changed to PR and the 
best response is PR.
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Timepoint Response: Patients with Non-Target Lesion Assessments
Non-Target 
Lesions
New Lesions
Overall Response
Best Response for this 
Category also Requires
CR
No
CR
Normalization of tumor markers, 
tumor nodes < 10 mm
Non-CR/non-PD
No
Non-CR/non-PD
Not all evaluated
No
NE
Unequivocal PD
Any
PD
Any
Yes
PD
Note: Patients with a global deterioration of health status requiring discontinuation of treatment without objective 
evidence of disease progression at that time should be reported as “symptomatic deterioration”. This is a 
reason for stopping therapy, but is NOT objective PD. Every effort should be made to document the objective 
progression even after discontinuation of treatment.
Missing Assessments and Not Evaluable Designation
When no imaging/measurement is done at all at a particular time point, the patient is not 
evaluable (NE) at that time point. If only a subset of lesion measurements are made at an 
assessment, usually the case is also considered NE at that time point, unless a convincing 
argument can be made that the contribution of the individual missing lesion(s) would not 
change the assigned time point response, which is most likely to occur in the case of PD; e.g, if 
only 2 of 3 baseline target lesions are assessed and result in a >20% increase in the sum, then 
the patient would be assessed as a PD regardless of the missing lesion.
Patients with a global deterioration of health status requiring discontinuation of treatment 
without objective evidence of disease progression at that time should be classified as having 
symptomatic deterioration. Every effort should be made to document the objective progression, 
even after discontinuation of treatment.
In some circumstances, it may be difficult to distinguish residual disease from normal tissue. 
When the evaluation of CR depends on this determination, it is recommended that the residual 
lesion be investigated (fine needle aspiration/biopsy) before confirming the CR status.
Confirmatory Measurement/Duration of Response
Confirmation
Radiographic tumor assessments are required. If an initial CR or PR is noted, confirmatory 
scans must be performed at least 4 weeks later. In the case of SD, follow-up measurements 
must have met the SD criteria at least once after study entry at a minimum interval of no less 
than 4 weeks.
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Duration of Overall Response
The duration of overall response is measured from the time measurement criteria are met for 
CR or PR (whichever is first recorded) until the first date that recurrent or PD is objectively 
documented (taking as reference for PD the smallest measurements recorded since the 
treatment started).
The duration of overall CR is measured from the time measurement criteria are first met for 
CR until the first date that recurrent disease is objectively documented.
Duration of Stable Disease
Stable disease is measured from the start of the treatment until the criteria for progression are 
met, taking as reference the smallest measurements recorded since the treatment started.
Reference: Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in 
solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247.
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18 APPENDIX C: CONTRACEPTIVE AND BARRIER GUIDANCE
•
Female Participant Reproductive Inclusion Criteria
The criteria below are part of Inclusion Criteria (Section Contraception) and Section 6.6 and 
specify the reproductive requirements for including female participants.
A female patient is eligible to participate if she (a) is not pregnant or breastfeeding; (b) agrees 
to not donate eggs (ova, oocytes) for the purpose of reproduction from the time of screening 
through 45 days after the last dose of PF-07901801 AND, for combination therapy with PLD,
during and for 6 months after treatment; and (c) at least one of the following conditions 
applies:
•
Is not a WOCBP
OR
•
Is a WOCBP who agrees to use a highly effective contraceptive method (failure rate of 
<1% per year) with low user dependency during the intervention period and for at least 
45 days after the, last dose of PF-07901801 AND for combination therapy with PLD, 
during and for 6 months after treatment, which corresponds to the time needed to 
eliminate any reproductive safety risk of the study intervention(s). The investigator 
should evaluate the effectiveness of the contraceptive method in relationship to the first 
dose of study intervention.
OR
•
Is a WOCBP and agrees to use a highly effective (failure rate of <1% per year) user-
dependent method of contraception during the intervention period and for at least 45 
days after the last dose of PF-07901801 AND for combination therapy with PLD, 
during and for 6 months after treatment, which corresponds to the time needed to 
eliminate any reproductive safety risk of the study intervention(s). In addition to her use 
of the highly effective method above, she agrees to concurrently use an effective barrier 
method. The investigator should evaluate the effectiveness of the contraceptive method 
in relationship to the first dose of study intervention.
The investigator is responsible for reviewing the woman’s medical history, menstrual history, 
and recent sexual activity in order to decrease the risk of enrolling a woman with an early, 
undetected pregnancy.
•
Woman of Childbearing and Non-Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered.
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Women in the following categories are not considered WOCBP:
1. Pre-menopausal female with 1 of the following: 
•
Documented hysterectomy
•
Documented bilateral salpingectomy
•
Documented bilateral oophorectomy
For individuals with permanent infertility due to a medical cause other than the above 
(eg, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry. 
Note: Documentation for any of the above categories can come from the site 
personnel’s review of the participant’s medical records, medical examination or 
medical history interview. The method of documentation should be recorded in the 
participant’s medical record for the study.
2. Post-menopausal female:
•
A post-menopausal state is defined as no menses for 12 months without an 
alternative medical cause. In addition
•
A high FSH level in the post-menopausal range must be used to confirm a post-
menopausal state in women under 60 years of age and not using hormonal 
contraception or HRT
•
A female on HRT and whose menopausal status is in doubt will be required to use 
one of the highly effective non-estrogen hormonal contraception methods if she 
wishes to continue her HRT during the study. Otherwise, she must discontinue HRT 
to allow confirmation of post-menopausal status before study enrollment
•
Contraception Methods
Contraceptive use by women should be consistent with local availability/regulations regarding 
the use of contraceptive methods for those participating in clinical trials.
The following contraceptive methods are appropriate for this study:
Highly Effective Methods That Have Low User Dependency 
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation
2. Intrauterine device
3. Intrauterine hormone-releasing system
4. Bilateral tubal occlusion
5. Vasectomized partner
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•
Vasectomized partner is a highly effective contraceptive method provided that the partner 
is the sole sexual partner of the WOCBP and the absence of sperm has been confirmed. If 
not, an additional highly effective method of contraception should be used. The 
spermatogenesis cycle is approximately 90 days.
Highly Effective Methods That Are User-Dependent
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation:
•
Oral + barrier*
•
Intravaginal + barrier*
•
Transdermal + barrier*
7. Progestogen-only hormone contraception associated with inhibition of ovulation:
•
Oral + barrier*
•
Injectable + barrier*
Sexual Abstinence
8. Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study intervention. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the 
study and the preferred and usual lifestyle of the participant.
* Acceptable barrier methods to be used concomitantly with options 6 or 7 for the study 
include any of the following:
•
Male or female condom with or without spermicide;
•
Cervical cap, diaphragm, or sponge with spermicide;
•
A combination of male condom with either cervical cap, diaphragm or sponge with 
spermicide (double-barrier methods).
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19 APPENDIX D: LIVER SAFETY: SUGGESTED ACTION AND FOLLOW-UP 
ASSESSMENTS
Potential Cases of Drug Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a more 
serious potential outcome. These participants fail to adapt and therefore are "susceptible" to 
progressive and serious liver injury, commonly referred to as DILI. Participants who 
experience a transaminase elevation above 3 × ULN should be monitored more frequently to 
determine if they are “adaptors” or are “susceptible.”
In the majority of DILI cases, elevations in AST and/or ALT precede T bili elevations (>2 × 
ULN) by several days or weeks. The increase in T bili typically occurs while AST/ALT is/are 
still elevated above 3 × ULN (i.e., AST/ALT and T bili values will be elevated within the same 
laboratory sample). In rare instances, by the time T bili elevations are detected, AST/ALT 
values might have decreased. This occurrence is still regarded as a potential DILI. Therefore, 
abnormal elevations in either AST OR ALT in addition to T bili that meet the criteria outlined 
below are considered potential DILI (assessed per Hy’s law criteria) cases and should always 
be considered important medical events, even before all other possible causes of liver injury 
have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions. Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI (Hy’s 
law) cases to definitively determine the etiology of the abnormal laboratory values:
•
Participants with AST/ALT and T bili baseline values within the normal range who 
subsequently present with AST OR ALT values ≥3 × ULN AND a T bili value 
≥2 × ULN with no evidence of hemolysis and an alkaline phosphatase value <2 × ULN 
or not available.
For participants with baseline AST OR ALT OR T bili values above the ULN, the following 
threshold values are used in the definition mentioned above, as needed, depending on which 
values are above the ULN at baseline:
•
Pre-existing AST or ALT baseline values above the normal range: AST or ALT values 
≥2 times the baseline values AND ≥3 × ULN; or ≥8 × ULN (whichever is smaller)
•
Pre-existing values of T bili above the normal range: T bili level increased from 
baseline value by an amount of >1 × ULN or if the value reaches ≥3 × ULN (whichever 
is smaller)
Rises in AST/ALT and T bili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 
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The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results. This evaluation should 
include laboratory tests, detailed history and physical assessment. 
In addition to repeating measurements of AST and ALT and T bili for suspected Hy’s law 
cases, additional laboratory tests should include albumin, CK, direct and indirect bilirubin, 
GGT, PT/INR, total bile acids, and alkaline phosphatase. Consideration should also be given to
drawing a separate tube of clotted blood and an anti-coagulated tube of blood for further 
testing, as needed, for further contemporaneous analyses at the time of the recognized initial 
abnormalities to determine etiology. 
A detailed history, including relevant information, such as review of ethanol, 
acetaminophen/paracetamol (either by itself or as a co-formulated product in prescription or 
over-the-counter medications), recreational drug or supplement (herbal) use and consumption, 
family history, sexual history, travel history, history of contact with a jaundiced person, 
surgery, blood transfusion, history of liver or allergic disease, and potential occupational 
exposure to chemicals, should be collected. Further testing for acute hepatitis A, B, C, D and E 
infection, liver imaging (eg, biliary tract) and collection of serum samples for 
acetaminophen/paracetamol drug and/or protein adduct levels may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and T 
bili elevation defined above should be considered potential DILI (Hy’s law) cases if no other 
reason for the LFT abnormalities has yet been found. Such potential DILI (Hy’s law) cases are 
to be reported as SAEs, irrespective of availability of all the results of the investigations 
performed to determine etiology of the LFT abnormalities. 
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of reasonable 
investigations have been received and have excluded an alternative etiology.
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20 APPENDIX E: KIDNEY SAFETY: MONITORING GUIDELINES
Laboratory Assessment of Change in Kidney Function and Detection of Kidney Injury
Standard kidney safety monitoring requires assessment of baseline and post-baseline (Scr 
measurement to eGFR [Scr-based eGFR]) or eCrCl.  Baseline and post baseline Scys makes it 
feasible to distinguish acute kidney injury (AKI) from other causes of Scr increase. If Scr 
increase is confirmed after baseline, then reflex measurement of Scys is indicated to estimate 
the combined Scr-Scys eGFR calculation (for adults only).
Regardless of whether kidney function monitoring tests are required as a routine safety 
monitoring procedure in the study, if the investigator or sponsor deems it necessary to further 
assess kidney safety and quantify kidney function, then these test results should be managed 
and followed per standard of care.
Age-Specific Kidney Function Calculation Recommendations
Adults (18 Years and Above)—2021 CKD-EPI Equations
2021 CKD-EPI 
Scr only
Scr
(mg/dL)
Scys
(mg/L)
Recommended eGFR Equation
Female
if ≤ 0.7
N/A
eGFR = 143 × (Scr/0.7)-0.241 × (0.9938)Age
Female
if > 0.7
N/A
eGFR = 143 × (Scr/0.7)-1.200 × (0.9938)Age
Male
if ≤ 0.9
N/A
eGFR = 142 × (Scr/0.9)-0.302 × (0.9938)Age
Male
if > 0.9
N/A
eGFR = 142 × (Scr/0.9)-1.200 × (0.9938)Age
2021 CKD-EPI
Scr-Scys Combined
Scr
(mg/dL)
Scys
(mg/L)
Recommended eGFR Equation
Female
if ≤ 0.7
if ≤ 0.8
eGFR = 130 × (Scr/0.7)-0.219 × (Scys/0.8)-0.323 × (0.9961)Age
Female
if ≤ 0.7
if > 0.8
eGFR = 130 × (Scr/0.7)-0.219 × (Scys/0.8)-0.778 × (0.9961)Age
Female
if > 0.7
if ≤ 0.8
eGFR = 130 × (Scr/0.7)-0.544 × (Scys/0.8)-0.323 × (0.9961)Age
Female
if > 0.7
if > 0.8
eGFR = 130 × (Scr/0.7)-0.544 × (Scys/0.8)-0.778 × (0.9961)Age
Male
if ≤ 0.9
if ≤ 0.8
eGFR = 135 × (Scr/0.9)-0.144 × (Scys/0.8)-0.323 × (0.9961)Age
Male
if ≤ 0.9
if > 0.8
eGFR = 135 × (Scr/0.9)-0.144 × (Scys/0.8)-0.778 × (0.9961)Age
Male
if > 0.9
if ≤ 0.8
eGFR = 135 × (Scr/0.9)-0.544 × (Scys/0.8)-0.323 × (0.9961)Age
Male
if > 0.9
if > 0.8
eGFR = 135 × (Scr/0.9)-0.544 × (Scys/0.8)-0.778 × (0.9961)Age
Inker LA et al. (2021)42
Adolescents (12 Years to <18 Years)—Cockcroft-Gault Formula
CrCl (mL/min) 
Males: CrCl = [(140-age) × body weight (in kg)] / [Scr (in mg/dL) × 72]
Females: CrCl = 0.85 × [(140-age) x body weight (in kg)] / [Scr (in mg/dL) × 72]
Children (2 years to <12 years)—Modified Schwartz Equation
CrCl normalized to BSA (mL/min/1.73 m2) = (K × Ht)/ Scr
Ht in cm; Scr in mg/dL.
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K (proportionality constant): Female Child < 12 years: K = 0.55. Male Child < 12 years: K = 
0.70
Infants (1 month to <2 years) and Neonates (<1 month)—Bedside Schwartz Equation
eGFR (mL/min/1.73 m2) = 0.413 × (Ht/Scr)
Ht in cm ; Scr in mg/dL.
Adverse Event Grading for Kidney Safety Laboratory Abnormalities
AE grading for decline in kidney function (ie, eGFR or eCrCl) will be according to CTCAE 
criteria.
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21 APPENDIX G: DOCUMENT HISTORY
Version
Date
1.3
26-Aug-2021
2.0
07-Dec-2022
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SUMMARY OF CHANGES IN VERSION 2
Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
Synopsis/ 
Section 3.7.1 
(PF-07901801)/ 
Section 5.1 (Study 
Design)/ Section 6.2 
(Inclusion Criteria)
Updated and added text:
Participants with prior exposure to anthracyclines including PLD while platinum-resistant 
or in the treatment regimen immediately prior to enrollment in this study, will be not 
be eligible for treatment under this protocol; however, earlier exposure to PLD, including 
while platinum-sensitive, or for an indication other than recurrent platinum-resistant 
EOC, eg, breast cancer, will be allowed for participants in the Phase 1 dose escalation 
portion of the study. In the Phase 2, dose expansion portion of the study, depending on 
clinical benefit during Phase 1, earlier exposure to PLD, including while platinum-
sensitive, may be allowed if agreed upon by the investigators and Pfizer. Prior 
treatment with doxorubicin or other anthracyclines’ equivalents at total cumulative 
doses must not be greater than 320 mg/m2 for doxorubicin, and calculated using 
doxorubicin equivalent doses: 1 mg doxorubicin= 1 mg pegylated liposomal 
doxorubicin (PLD)= 1.8 mg epirubicin= 0.3 mg mitoxantrone= 0.25 mg idarubicin.
Up to approximately 18 participants are planned to be enrolled in this portion of the study to 
evaluate three dose levels of PF-07901801: 12 mg/kg (Dose Level 1), 2418 mg/kg (Dose 
Level 2) and 4824 mg/kg (Dose Level 3). 
In Cycle 1 for dose levels 1 and 2, PF-07901801 will be administered on Day 1, Day 8, 
Day 15 and Day 22 in combination with PLD on Day 1 of 28-day cycle. Beginning with 
Cycle 2 at dose levels 1 and 2, PF-07901801 will be administered on Day 1 and Day 15 in 
combination with PLD on Day 1 of 28-day cycles. The enhanced dosing in Cycle 1 
represents a loading cycle and is intended to allow PF-07901801 levels to more quickly 
reach steady state. For dose level 3, PF-07901801 will be administered on Day 1 and Day 
15 in combination with PLD on Day 1 of 28-day cycles.
Dose level 3 will be biweekly regimen from the start.
This criterion update 
releases the barrier to 
enrollment: it allows 
earlier anthracyclines 
under the limitation of 
total cumulative doses 
associated with 
increased risk of 
cardiomyopathy in a 
manner that is 
considered not 
anticipated to impact 
efficacy and safety
Substantial
Synopsis and/or
Added, revised and updated text in the objectives and endpoints:
Updated information 
Substantial
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Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
Section 5.1 (Study 
design)
Secondary objectives include further evaluation of the safety of the combination and 
assessment of other indicators of clinical benefit disease control, including progression-free 
survival, overall survival, duration of response, and clinical benefit disease control (CR, 
PR, or SD ≥12 weeks) rate as defined by RECIST v1.1 criteria. and assessment of overall 
response and other markers of clinical benefit as defined by immune-related RECIST 
(irRECIST) criteria.
Exploratory objectives include assessment of the pharmacodynamic effects of PF-
07901801(TTI-622) in combination with PLD in peripheral blood samples and tumor tissue, 
evaluation of CA-125 levels, characterization of PF-07901801 and PLD
pharmacokinetics concentrations in serum when co-administered in combination with 
PLD, evaluation of development of antibodies directed against PF-07901801; exploration of 
possible relationships between PF-07901801 exposure and clinical outcome, safety and 
pharmacodynamics observations, and to understand the relationship between the 
therapeutic intervention(s) being studied and the biology of participant’s disease 
assessment of possible relationships between CD47 expression on tumor cells and clinical 
outcome, safety and pharmacodynamic observations. Exploratory endpoints may include 
but are not limited to PK and immunogenicity of PF-07901801, PK of PLD, CA-125 
levels assessment of correlation between CD47 expression by immunohistochemistry and 
clinical outcome; evaluation of associations between clinical activity and selected 
biomarkers measured in serial peripheral blood samples, such as T-cell receptor clonality, 
immunophenotyping of circulating immune cells, circulating cytokines, immune function 
assays; and evaluation of the association between clinical activity and selected biomarkers 
measured in tumor tissue, such as immune infiltrate by IHC (including CD68 and CD163), 
somatic mutations utilizing high-throughput sequencing, and gene expression profiling. 
measurements of biomarkers/pharmacodynamics, which may consist of DNA, RNA, 
protein or defined cell types, resulting from analyses of peripheral blood and/or tumor 
tissue biospecimen obtained at baseline, on treatment and/or at end of study, as well as 
the single and multiple dose pharmacokinetics of PF-07901801.
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Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
PLD should be administered through a freeflowing catheter as a 1 mg/min intravenous 
infusion. After Cycle 1, PLD can be delivered as a 1-hour infusion as tolerated in 
accordance with institutional
guidelines for use of PLD in this patient population. TTI-622 will be administered by 
intravenous infusion; the duration of infusion is dependent on dose level with dose levels 
<24 mg/kg infused over 60 minutes and the dose level of 24 mg/kg infused over 90 minutes.
In Cycle 1 only, TTI-622 will be administered by intravenous infusion on Day 1, Day 8, 
Day 15 and Day 22 in combination with PLD on Day 1 of 28-day cycles. Beginning with 
Cycle 2, TTI-622 will be administered on Day 1 and Day 15 in combination with PLD on 
Day 1 of 28-day cycles. The enhanced dosing in Cycle 1 represents a loading cycle and is 
intended to allow TTI-622 levels to more quickly reach steady state. For the purposes of 
safety decisions that guide cohort expansion and considerations of TTI-622 dose adjustment 
in the dose escalation portion of the study, The dose-limiting toxicity safety evaluation 
period will consist of the 28-day Cycle 1 or until participants experience a DLT in Cycle 
1.
A participant who withdraws from the study during Cycle 1 in the absence of objective 
disease progression or DLT evaluable (ie, not receiving PLD and at least two doses of 
PF-07901801) will be replaced. 
Objective disease assessments will be performed every 8 (±1) weeks through week 48, or 
until participant has been on study for one year, and every 12 (±2) weeks thereafter
after every second cycle of treatment for approximately 50 weeks and after every third cycle 
thereafter. A patient enrolled in an expansion cohort who withdraws or is withdrawn from 
the study prior to completion of two cycles of treatment and objective disease assessment 
after the second cycle for a reason other than disease progression or safety will be replaced 
in order to meet the statistical criteria for the Simon two-stage study design. 
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Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
The mechanism of immunotherapy is mechanistically distinct from other types of therapy. 
The patterns of response and progression to immunotherapeutic agents, such as TTI-622, 
often differ temporally, qualitatively and quantitatively from those observed with cytotoxic 
and targeted agents. The goal of immunotherapy is to overcome immunosuppression 
induced by a tumor and its microenvironment, thereby allowing the immune system to 
develop or activate an immune response that targets and kills cancer cells. Some patients 
have experienced pseudo-progression or immune-mediated inflammation, in which areas of 
disease showed an initial surge followed by shrinkage that led to development of immune-
related disease response criteria that supports continued treatment beyond progression in 
patients whose clinical conditions have not worsened and who have not experienced severe 
toxicities. Recognizing that immunotherapy represents a paradigm shift in oncology 
treatment, patients with a early observation of disease progression but without deterioration 
in clinical conditions or unacceptable toxicity and who consent should continue treatment 
until disease progression is verified by a repeated disease assessment at least four weeks 
later.
Synopsis/
Section 6.2 
(Inclusion criteria)
Removal of # 13 in the inclusion criteria:
•INR ≤ 1.5 x ULN (≤ 2.5 x ULN if on anti-coagulants) and PTT ≤ 5 seconds above the ULN
unless receiving anti-coagulation therapy; patients on full-dose anti-coagulation must be on 
a stable dose of oral anti-coagulant or low molecular weight heparin, have therapeutic INR, 
no active bleeding (defined as within 14 days prior to first dose of study medication) and no 
pathological condition that carries a high risk of bleeding (e.g., tumor involving major 
vessels or known varices)
Not applicable
Substantial
Synopsis/Section 
5.1 (Overall Study 
Design)/
Section 6.2 
(Inclusion Criteria)
Added, revised and updated text in the Previous Therapy section:
15. Unlimited lines of therapies in the platinum-sensitive setting are allowed. Once a 
participant becomes platinum-resistant no more than 4 prior treatment regimens for 
platinum-resistant disease are allowed. including lines of therapy in the recurrent setting. 
NOTE: frontline treatment/maintenance therapy does not count towards the 4-line 
maximum
16. Participants with exposure to PLD while platinum-resistant or in the treatment 
regimen immediately prior to enrollment in this study, will not be eligible for 
treatment under this protocol; however, earlier exposure to PLD, including while 
Updated to reflect new 
information
Substantial
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Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
platinum-sensitive, or for an indication other than recurrent platinum-resistant EOC, 
eg, breast cancer, will be allowed for participants in the Phase 1 dose escalation 
portion of the study. In the Phase 2, dose expansion portion of the study, depending on 
clinical benefit during Phase 1, earlier exposure to PLD, including while platinum-
sensitive, may be allowed if agreed upon by the investigators and Pfizer. Prior 
treatment with doxorubicin or other anthracyclines’ equivalents at total cumulative 
doses must not be greater than 320 mg/m2 for doxorubicin, and calculated using 
doxorubicin equivalent doses: 1 mg doxorubicin= 1 mg pegylated liposomal 
doxorubicin (PLD)= 1.8 mg epirubicin= 0.3 mg mitoxantrone= 0.25 mg idarubicin. 
Anthracycline-naïve (anthracycline in any prior setting, including the neoadjuvant/adjuvant 
or advanced stage settings, renders the participant ineligible for participation)
Synopsis/
Section 6.3 
(Exclusion Criteria)
Revised, added and updated text in the exclusion criteria:
Non-epithelial histology, including mMalignant mixed Mullerian tumors
Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and sponsor 
delegate employees directly involved in the conduct of the study and their family 
members.
Any comorbidity or concomitant medication or other medical or psychiatric condition
including recent (within the past year) or active suicidal ideation/behavior or 
laboratory abnormality that may increase the risk of study participation that in the 
opinion of the investigator and/or sponsor medical monitor renders the participant 
unsuitable for participation in the trial or unlikely to fully comply with study procedures, 
restrictions and/or requirements that are considered relevant for evaluation of the efficacy or 
safety of the trial drug. Consideration should be given to SARS-CoV-2 vaccination status as 
a condition that may render a patient unsuitable for participation in the trial or unlikely or 
unable to fully comply with study procedures, restrictions and/or requirements that are 
considered relevant for the evaluation of the efficacy or safety of study treatment
Updated information
Substantial
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Change
Rationale
Substantial 
or Non-
Substantial
Uncontrolled intercurrent illness, including active or chronic infection uncontrolled 
bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and 
known HIV or AIDS related illness infection requiring systemic therapy or oral or 
systemic antibiotics within 14 days prior to study start. Participants with HIV with an 
undetectable viral load and a CD4 count ≥400 μL are eligible.
COVID-19/SARS-CoV-2: While SARS-CoV-2 testing is not mandated for entry into 
this study, testing should follow local clinical practice standards. If a participant has a 
positive test result for SARS-CoV-2 infection, is known to have asymptomatic infection 
or is suspected of having SARS-CoV-2, the participant is excluded until a negative 
antigen test and resolution of symptoms if applicable.
Significant bleeding disorders, vasculitis or a significant bleeding episode from the GI tract
within three months prior to study entry. 
Ongoing prophylactic anticoagulation therapy at a stable dose for prevention of VTE 
(Venous Thromboembolism) are allowed. Note: Participant on therapeutic 
anticoagulation must not be started on study before therapy is completed and 
prophylactic anticoagulation is established.
Chronic Ssystemic steroid therapy (> 10 mg daily prednisone or equivalent) or any other 
form of immunosuppressive therapy within seven days prior to the first dose of study 
treatment; topical, inhaled, nasal and ophthalmic steroids are not prohibited; Intermittent 
prophylaxis per site institutional policy is not prohibited as long as it does not exceed 
chronic daily use of >10 mg prednisone or equivalent eg, prophylactic use of steroids 
for Palmar Plantar Erythrodysesthesia (PPE) toxicity with PLD is allowed.
Synopsis/
Section 4.5 
(Exploratory 
Objectives)
Some minor editorial clarifications made in the primary and secondary objectives are not 
described in this Summary of Change.
Revised and added text in the exploratory objectives:
Updated information
Substantial
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Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
• Assess the pharmacodynamic effects of TTI-622 in combination with PLD in peripheral 
blood samples and tumor tissue
•
Characterize the PLD concentration in plasma when administered in combination 
with PF-07901801
•
Assess DDI potential between PF-07901801 and PLD
•
Understand the relationship between the therapeutic intervention(s) being studied 
and the biology of the participant’s disease.
Explore possible relationships between CD47 expression on tumor cells and clinical 
outcome, safety and pharmacodynamics observations
Synopsis/
Section 4.2 
(Primary 
Endpoints)/ Section 
4.4 (Secondary 
Endpoints)/Section 
4.6 (Exploratory 
Endpoints)
Added, updated and revised text:
Primary:
•
Overall safety profile as assessed by the type, frequency, severity, timing and 
causal relationship of any adverse events, changes in vital signs, ECG, serum 
chemistry or other laboratory assessment, treatment delays or discontinuations
DLTs during the DLT observation period (28 days following C1D1).
•
The percentage of patients with o Objective response (CR, PR) as defined by 
RECIST v1.1 criteria
Secondary:
•
PFS, OS, disease control rate (DC [CR +or PR + or SD]), and DOR, duration of 
disease control, time to progression and time to (new) metastases as defined by 
RECIST v1.1 criteria, time to worsening of ECOG performance status
•
Response rate and other markers of clinical benefit as defined by immune-related 
RECIST (irRECIST) criteria
Exploratory:
All the evaluations of selected biomarkers have been removed and the text was updated:
•
Measurements of biomarkers/pharmacokinetics, which may consist of DNA, 
RNA, protein or defined cell types, resulting from analyses of peripheral
blood and/or tumor tissue biospecimen obtained at baseline, on treatment 
and/or at end of study.
Updated information 
on primary, secondary 
and exploratory 
endpoints
Substantial
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Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
•
Immunogenicity: Incidence and titers of ADA and neutralizing antibodies 
against PF-7901801
•
PF-07901801 PK: Single and multiple Dose Cmax, 
, and
clearance.
•
PLD PK: Single and multiple dose Cmax and Ctrough.
Synopsis/ Section 
3.7.1 (PF-
07901801)/ Section 
5.1 (Overall Study 
design)/ Section 
5.2.2 (PF-
07901801)
Updated text:
The dose of PF-07901801 will be based upon the dose level cohort to which the participant 
is assigned; the duration of infusion is dependent on dose level: dose levels <24 mg/kg are 
infused over 60 minutes and the >24 mg/kg dose level is infused over 90 minutes less than 
or equal to 33 mg/kg infused over 60 min and doses greater than 33 mg/kg infused 
over 90 minutes and will have doses equal to or less than 2500 mg in 250 mL and doses 
2501 mg or more in 500 mL or neat drug if the drug volume is over 500 mL.
In Cycle 1 for dose levels 12 mg/kg and 24 mg/kg only, PF-07901801 will be 
administered on Day 1, Day 8, Day 15 and Day 22 of a 28-day cycle. The enhanced dosing 
in Cycle 1 represents a loading cycle and is intended to allow PF-07901801 levels to 
more quickly reach steady state.
For dose level 48 mg/kg , PF-07901801 will be administered on Day 1 and Day 15 of a 
28-day cycle. Loading doses (Day 8 and Day 22) may be considered for Cycle 1 at the 
48 mg/kg dose level if found to be safe and offer clinical benefit for participants. If 
Cycle 1 loading doses are implemented, all dosing and lab draw schedules for the 48 
mg/kg dose will follow the schedules for dose levels 12 mg/kg and 24 mg/kg.
The enhanced dosing in Cycle 1 represents a loading cycle and is intended to allow TTI-622 
levels to more quickly reach steady state.
Updated information
Substantial
Section 3.5.2.2
Revised and updated text with tables provided for single and multiple dose PK parameters 
of PF-07901801 for this Section ‘Pharmacokinetics and Immunogenicity in Humans’.
Updated information
Substantial
Section 3.7.1/ 
Section 5.2.2
Dose levels of PF-07901801 have been updated in Table 10 and in Table 12.
Updated dose levels
Substantial
Section 4.
Updated and revised text for the primary objectives and endpoints, secondary objectives and 
endpoints, and exploratory objectives and endpoints.
Revised information
Substantial
Section 8.3.1
Revised text for the Section ‘PF-07901801
Updated information
Substantial
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Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
Section 8.7.2
Revised text
Updated information
Substantial
Section 8.7.4
Addition of Section 8.7.4 ‘Prohibited Medication and Potential Drug-Drug Interactions 
(DDI)
Updated information
Substantial
Section 9.2.5
Revised and updated text
Updated information
Substantial
Section 10
Updated and revised Table 28, Table 29, Table 30, Table 31, and Table 32.
Addition of Subheadings 10.1; 10.2; 10.3
Updated information
Substantial
Section 11
Updated and revised text
Updated information
Substantial
Section 12.1.2
Added language
If the dose level combination selected for further Phase 2 is determined to be not 
optimal or not well tolerated, an intermediate dose level, not to exceed the dose levels 
evaluated in Phase 1, may be implemented.  
Updated information
Substantial
Section 12.3.3
Addition of Section 12.3.3 ‘PLD Concentration’
Updated information
Substantial
Section 13.1.1
Added language on AEs and SAEs
Updated information
Substantial
Section 13.5.3
Addition of Section 13.5.3 ‘Time period and Frequency for Collecting AE and SAE 
Information’
Updated information
Substantial
Section 13.5.4
Addition of Section 13.5.4 ‘Documentation’
Updated information
Substantial
Section 13.5.5
Addition of Section 13.5.5 ‘Follow-Up’
Update information
Substantial
Section 13.5.6
Addition of Section 13.5.6 ‘Notification’
Updated information
Substantial
Section 13.5.7
Addition of Section 13.5.7 ‘Regulatory Reporting Requirements for SAEs
Updated information
Substantial
Section 13.6
Addition of Section 13.6 ‘Adverse Events of Special Interest
Updated information
Substantial
Section 13.7 
Addition of Section 13.7 ‘Lack of Efficacy’
Updated information
Substantial
Section 13.8, 
Section 13.8.1,
Section 13.8.2
Section ‘Pregnancy or Drug Exposure during Pregnancy’ has been divided in 2 
sections:‘Exposure during Pregnancy’, and ‘Exposure During Breastfeeding’. The text was 
also updated.
Updated information
Substantial
Section 13.8.5
Addition of Section 13.8.5 ‘Disease-related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs’
Updated information
Substantial
Section 13.9 
Addition of Section 13.9 ‘Medication Error’
Updated information
Substantial
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Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
Section ‘Reporting
Adverse Events’
Removal of the section ‘Reporting Adverse Events’
Updated information
Substantial
Section 13.12
Addition of Section 10.12 ‘Overview of Safety Monitoring’
Updated information
Substantial
Section 14.14
Addition of language on Dissemination of Clinical Study, Documents within Marketing 
Authorization Applications, and Data Sharing, 
Updated information
Substantial
Appendices C, E, F
Addition of Appendix C: Contraceptive and Barrier Guidance
Addition of Appendix E: Liver Safety
Addition of Appendix F: Kidney Safety
Contraceptive 
guidance, liver and 
kidney safety guidance 
have been updated for 
harmonization across 
sponsor studies.
Substantial
All Sections
Minor editorial modifications in the text, which are not provided in this summary of 
changes, were made for additional clarity.
Clarification
Non-
substantial
Synopsis/
Section 5.1 (Overall 
Study Design)
Revised/added text: 
This study will investigate a new therapeutic regimen for participants with platinum-
resistant recurrent epithelial ovarian cancer (EOC), defined as disease progression >1 
month and ≤6 months after at least four cycles of the most recent platinum-based treatment 
regimen or participants who were no longer able to receive or declined treatment with 
platinum-based chemotherapy, and who have not received more than four regimens for 
platinum-resistant disease. 
Updated information
Non-
substantial
Synopsis/ Section 
6.1 (Inclusion 
Criteria)
Revised text for clarification of number of participants per phase:
Up to approximately 50 participants, including up to approximately 18 DLT-evaluable in 
the Phase 1 dose escalation portion of the study and up to approximately 30 treated in the 
Phase 2 expansion cohort portion. 
Updated for 
clarification
Non-
substantial
Synopsis
Removal of the ‘Enrollment Period’ row:The enrollment period is anticipated to be 
approximately 15 months in duration, with the first patient anticipated to be enrolled in 
September 2021 and completion of enrollment anticipated for December 2022.
Information not 
required
Non-
substantial
Synopsis/ Section 
5.1 Overall Study 
Design/Section 12.2 
Updated text in the paragraph:
A participant will be evaluable for dose-limiting toxicity if she has the participant 
experiences a DLT during Cycle 1 or did not experience a DLT and received PLD on 
Updated information
Non-
substantial
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Rationale
Substantial 
or Non-
Substantial
Analysis 
Populations
Day 1 and, received at least two infusions of PF-07901801 (TTI-622) in the 28-day Cycle 1 
and were evaluable for safety for the completed 28-day cycle safety evaluation period. The 
requirement for a minimum of two infusions of PF-07901801 during Cycle 1 is based on the 
infusion schedule for all cycles beyond Cycle 1, in which PF-07901801 (TTI-622) will be 
administered only on Day 1 and Day 15 of each 28-day cycle. A participant who withdraws 
from the study during Cycle 1 in the absence of objective disease progression or DLT 
evaluable (ie, not receiving PLD and at least two doses of PF-07901801) will be 
replaced.
Synopsis/
Section 5.4 (Dose 
limiting toxicity 
criteria)
Added and updated text in the 
paragraph:
o
Updated information
Non-
substantial
Synopsis/
Section 6.2 
(Inclusion criteria)
Revised text and updated text:
17. If sexually active, the patient must be post-menopausal, surgically sterile or using 
effective contraception. Effective contraception for women of child-bearing potential is 
defined as one barrier method (e.g., condom) and one additional method (e.g., hormonal) of 
contraception during the study and for at least three months from the last administration of 
TTI-622 and six months from the last administration of PLD (abstinence is acceptable if this 
is the usual lifestyle and preferred method of contraception for the subject)
18. Women of child-bearing potential may not be breastfeeding and must have a negative 
serum pregnancy test within 72 hours prior to start of study treatment Female participants 
of childbearing potential must have a serum pregnancy test at screening (Appendix D). 
Following Screening, pregnancy tests may be urine or serum tests, and must have a 
sensitivity of at least 25 mIU/mL. A negative pregnancy test result at screening and at 
baseline is required before the first study drug administration.
Contraceptive 
requirements have 
been updated and 
harmonized across 
sponsor studies.
Non-
substantial
Synopsis/ Section 
12.1.2 (Expansion 
Cohort)
Revised and updated text:
Based on a standard 3+3 design, up to approximately six DLT-evaluable participants may 
be enrolled in each dose level cohort evaluated during the Phase 1 dose escalation portion 
Updated information
Non-
substantial
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Section (s)
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Rationale
Substantial 
or Non-
Substantial
of the study; a minimum of nine and a maximum of 18 DLT-evaluable participants who 
complete the safety review period is anticipated.
The Phase 2 expansion cohort is anticipated to provide a reasonable estimate of disease 
control, defined for this study as objective response rate among 25 treated participants, 
defined by RECIST v1.1 criteria, to support planning of future studies. 
Because this endpoint is based on these statistical considerations, a patient who is 
withdrawn from the expansion arm of the study for a reason other than safety or objective 
disease progression and is not evaluable for response, defined as having completed at least 
two cycles of treatment as described in this protocol and having a post-treatment objective 
disease assessment, will be replaced in order to have at least 25 patients available for 
evaluation of response.
Other evidence of clinical activity, such as duration of response, progression-free survival, 
and overall survival will be evaluated descriptively. and time to progression which are 
poor in this patient population, will be considered although the sample size is not 
anticipated to be sufficiently large to allow statistical evaluation of these endpoints in this 
hypothesis-generating study.
Section 5.2 
Updated text for the dose escalation 
Updated information
Non-
substantial 
Section 5.3 
Updated text:
Any treatment-related adverse event that is deemed life-threatening, regardless of grade. 
For Grade 4 adverse events, discontinuation must be considered unless the adverse 
event is transient and/or monitorable and manageable, asymptomatic and/or not 
clinically significant. If the participant is receiving disease control and the investigator 
judges that continued treatment may be in the participants best interest, PF-07901801 
treatment can be resumed when the adverse event resolves to a level that meets re-
treatment criteria. In consultation with the sponsor medical monitor, the dose level 
may be resumed
Addition of this paragraph which was previously in the synopsis:
Updated information
Non-
substantial 
090177e19c0f4cdd\Approved\Approved On: 13-Dec-2022 09:14 (GMT)


TTI-622 (SIRPα-IgG4 Fc) PF-07901801
Pfizer Inc
Clinical Protocol C4971002
Version 2.0 07 December 2022
Confidential
Page 154 of 156
Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
The mechanism of immunotherapy is mechanistically distinct from other types of 
therapy.  The patterns of response and progression to immunotherapeutic agents, such 
as TTI-622, often differ temporally, qualitatively and quantitatively from those 
observed with cytotoxic and targeted agents.  The goal of immunotherapy is to 
overcome immunosuppression induced by a tumor and its microenvironment, thereby 
allowing the immune system to develop or activate an immune response that targets 
and kills cancer cells.  Some patients have experienced pseudo-progression or immune-
mediated inflammation, in which areas of disease showed an initial surge followed by 
shrinkage that led to development of immune-related disease response criteria that 
supports continued treatment beyond progression in patients whose clinical conditions 
have not worsened and who have not experienced severe toxicities.  Recognizing that 
immunotherapy represents a paradigm shift in oncology treatment, patients with an 
early observation of disease progression but without deterioration in clinical 
conditions or unacceptable toxicity and who consent should continue treatment until 
disease progression is verified by a repeated disease assessment at least four weeks 
later.
Section 6.5
Revised text:
In general, waivers of inclusion or exclusion criteria will not be granted; the Investigator 
may consult with the Medical Monitor on a case-by-case. Prospective approval of 
protocol deviations to recruitment and enrollment criteria, also known as protocol 
waivers or exemptions, is not permitted.
Updated information
Non-
substantial
Section 6.6
Revised text for the Section ‘Patients of Reproductive Potential’
Updated information
Non-
substantial
Section 8.3.2
Revised text for Section Pegylated Liposomal Doxorubicin
Updated information
Non-
substantial
Section 8.7
Removal of the following paragraphs:
Patients must not receive live, attenuated vaccines (e.g., FluMist) within four weeks prior 
to first day of study treatment, at any time during the study, or through 90 days after the last 
dose of TTI-622. Inactivated vaccines are allowed. Influenza vaccination should be given 
during influenza season only (approximately October to March).
Revised text due to 
updated information
Non-
substantial
090177e19c0f4cdd\Approved\Approved On: 13-Dec-2022 09:14 (GMT)


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Pfizer Inc
Clinical Protocol C4971002
Version 2.0 07 December 2022
Confidential
Page 155 of 156
Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
Doxorubicin, the active component of PLD, is a major substrate of cytochrome P450 
CYP3A4 and CYP2D6, and P-glycoprotein (P-gp). Clinically significant interactions have 
been reported with inhibitors of CYP3A4, CYP2D6, and/or P-gp (e.g., verapamil), resulting 
in increased concentration and clinical effect of doxorubicin. Inducers of CYP3A4 (e.g., 
phenobarbital, phenytoin, St. John’s Wort) and P-gp inducers may decrease the 
concentration of doxorubicin. While the Prescribing Information for PLD does not carry 
these statements, the Investigator may consider whether concurrent use of inhibitors and 
inducers of CYP3A4, CYP2D6 or P-gp is warranted or should be avoided when PLD is 
being administered or may wish to employ alternate medications when possible. The 
Investigator may consult with the Medical Monitor when considering use of one of these 
agents. 
Section 8.7.1
Added text:
Intermittent prophylaxis per site institutional policy is not prohibited as long as it does 
not exceed chronic daily use of >10 mg prednisone or equivalent e.g. prophylactic use 
of steroids for Palmar Plantar Erythrodysesthesia (PPE) toxicity with PLD is allowed.
Updated information
Non-
substantial
Section 9.2.6
Added text:
Note: Stimulating factors such as hematopoietic growth factors to stimulate white cell, red 
cell, or platelet production and transfusions are prohibited concomitant medications during 
cycle 1 (DLT period)
Updated information
Non-
substantial
Section 12.3.2
Updated and revised text
Updated information
Non-
substantial
Section 12.3.4
Revised and updated text
Updated information
Non-
substantial
Section 12.3.5
Updated text
Updated information
Non-
substantial
Section 13
Revised text
The observation phase for adverse events will start with signing the informed consent and 
will end in general with the last follow up visit. Adverse events occurring after signing of 
Updated information
Non-
substantial
090177e19c0f4cdd\Approved\Approved On: 13-Dec-2022 09:14 (GMT)


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Pfizer Inc
Clinical Protocol C4971002
Version 2.0 07 December 2022
Confidential
Page 156 of 156
Section (s)
Change
Rationale
Substantial 
or Non-
Substantial
the informed consent but prior to administration of any study treatment or prophylaxis will 
be considered medical history unless related to performance of a screening procedure. 
Adverse events still present at the end of the observation phase will be followed as long as 
possible. at the completion of the active reporting period. Planned timepoints for all 
safety assessments are provided in the Study Assessments (Section 10). Unscheduled 
safety measurements may be obtained at any time during the study to assess any 
perceived safety issues.
Section 13.1.2
Revised language 
Update for clarification
Non-
substantial
Section 13.2
Updated text
Updated information
Non-
substantial
Section 13.8.3
Addition of Section 13.8.3 ‘Occupational Exposure’
Updated information
Non-
substantial
Section 13.8.4
Addition of Section 13.8.4 ‘Cardiovascular and Death Events’
Updated information
Non-
substantial
Section 13.10
Provided clarification 
Updated information
Non-
substantial
Appendices C
Removal of Appendix C 
Updated information
Non-
substantial
Appendix G
Removal of Appendix G ‘Principal Investigator Acknowledgement Form’ and replaced by 
‘Document History’
Updated information
Non-
substantial
090177e19c0f4cdd\Approved\Approved On: 13-Dec-2022 09:14 (GMT)

SAP_001.pdf: 
 
 
Statistical A nal ysis Pla n 
 
T e m pl at e N o.: N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L 
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3 
R ef er e n c e: S O P C R 0 0 8, W P C R 0 1 3 
 
P a g e 1  of 4 6  
 
 
Pfi z er I n c. 
Pr ot o c ol #: C 4 9 7 1 0 0 2 ( T TI- 6 2 2- 0 2) 
 
 
A P h a s e I/II St u d y of P F- 0 7 9 0 1 8 0 1 ( T TI- 6 2 2) i n C o m bi n ati o n wit h P e g yl at e d 
Li p o s o m al D o x or u bi ci n ( P L D) i n P ati e nt s wit h Pl ati n u m- R e si st a nt O v ari a n C a n c er  
 
St ati sti c al A n al y si s Pl a n 
 
 
V er si o n 1. 0 
 
D o c u m e nt l a st s a v e d:  1 8- S e p- 2 0 2 3 7: 5 4 A M  
 
 
Pr e p ar e d b y:  
 
 
 
 
 
 S p. 
 
 
 
 
 
I Q VI A Bi ot e c h 
 
 
 
 
 
 
A p pr o v e d b y:  
 
 
 
 M S, M S P H 
 
  
 
Pfi z er , I n c. 
 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2  of 4 6  
 
T A B L E O F C O N T E N T S  
1.  
I N T R O D U C TI O N............................................................................................................... 7  
1. 1.  
Pr ot oc ol a n d A m e n d m e nt Hist or y  .............................................................................................................. 7  
1. 2.  
C h a n ges t o Pl a n ne d A n al yses fr o m Pr ot oc ol  ............................................................................................. 7  
1. 3.  
Re visi o n Hist or y of t he St atistic al A n al ysis Pl a n  ...................................................................................... 7  
2.  
S T U D Y O B J E C TI V E S  ....................................................................................................... 7  
2. 1.  
Pri m ar y O bjecti ve  ....................................................................................................................................... 7  
2. 2.  
Sec o n d ar y O bjecti ves  .................................................................................................................................. 8  
2. 3.  
E x pl or at or y O bjecti ves ................................................................................................................................ 8  
3.  
S T U D Y E N D P OI N T S  ......................................................................................................... 8  
3. 1.  
Pri m ar y E n d p oi nt  ........................................................................................................................................ 8  
3. 2.  
Sec o n d ar y E n d p oi nts  ................................................................................................................................... 8  
3. 3.  
E x pl or at or y E n d p oi nts  ................................................................................................................................ 9  
4.  
S T U D Y D E SI G N  ................................................................................................................. 9  
4. 1.  
Desi g n O ver vie w  .......................................................................................................................................... 9  
4. 2.  
S a m ple Size  ................................................................................................................................................. 1 0  
5.  
G E N E R A L A N A L Y TI C A L C O N SI D E R A TI O N S  ....................................................... 1 0  
5. 1.  
D at a S o urces  ............................................................................................................................................... 1 0  
5. 2.  
Defi n iti o n of B aseli ne ................................................................................................................................. 1 0  
5. 3.  
A n al ysis Visits a n d Wi n d o ws  .................................................................................................................... 1 1  
5. 4.  
Missi n g D at a  ............................................................................................................................................... 1 1  
5. 4. 1.  
Partial a n d Missi n g Dates  ........................................................................................................................ 1 1  
5. 4. 2.  
E x p os ure  .................................................................................................................................................. 1 3  
5. 4. 3.  
Last K n o w n Ali ve Date  ........................................................................................................................... 1 4  
5. 5.  
Ti mi n g of A n al yses  .................................................................................................................................... 1 4  
5. 6.  
A n al ysis P o p ul ati o ns  .................................................................................................................................. 1 4  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3  of 4 6  
 
5. 6. 1.  
Safet y A nal ysis Set ( S A S)  ....................................................................................................................... 1 4  
5. 6. 2.  
D L T -E val ua ble P o p ulati o n ( D L P)  ........................................................................................................... 1 5  
5. 6. 3.  
P F -0 7 9 0 1 8 0 1 / P L D C o nce ntrati o n A nal ysis P o p ulati o n ( P C P)  .............................................................. 1 5  
5. 6. 4.  
I m m u n o ge nicit y A nal ysis P o p ulati o n (I A P) ............................................................................................ 1 5  
5. 6. 5.  
P har mac o d y na mics A nal ysis P o p ulati o n ( P D P)  ...................................................................................... 1 5  
5. 7.  
D at a Dis pl a y C h ar a cteristics  .................................................................................................................... 1 6  
5. 7. 1.  
M ulti ple Assess me nts f or t he Sa me Assess me nt Ti me P oi nt  .................................................................. 1 7  
5. 8.  
S oft w are Versi o n  ........................................................................................................................................ 1 8  
6.  
S U B J E C T A C C O U N T A BI LI T Y  .................................................................................... 1 8  
6. 1.  
S u bject C h ar a cteristics .............................................................................................................................. 1 8  
6. 1. 1.  
De m o gra p h y  ............................................................................................................................................ 1 8  
6. 1. 2.  
Me dical Hist or y  ....................................................................................................................................... 1 9  
6. 1. 3.  
Ca n cer Hist or y  ......................................................................................................................................... 1 9  
6. 1. 4.  
Pri or S ur geries  ......................................................................................................................................... 1 9  
6. 1. 5.  
Pri or A nti -ca ncer Treat me nts  ................................................................................................................... 1 9  
6. 1. 6.  
C o nc o mita nt Me dicati o ns  ........................................................................................................................ 1 9  
6. 1. 7.  
C o nc o mita nt Pr oce d ures  .......................................................................................................................... 2 0  
6. 2.  
Dis p ositi o n  .................................................................................................................................................. 2 0  
6. 3.  
Pr ot oc ol De vi ati o ns  .................................................................................................................................... 2 0  
7.  
E F FI C A C Y A N A L Y S E S  ................................................................................................. 2 1  
7. 1.  
Effic ac y O utc o m es  ..................................................................................................................................... 2 1  
7. 1. 1.  
Pri mar y Efficac y O utc o me A nal ysis  ....................................................................................................... 2 3  
7. 1. 2.  
Sec o n dar y Efficac y O utc o me A nal ysis  ................................................................................................... 2 4  
8.  
S A F E T Y A N A L Y S E S  ...................................................................................................... 2 5  
8. 1.  
E x p os ure  ..................................................................................................................................................... 2 5  
8. 2.  
Tre at m e nt  C o m pli a nce  .............................................................................................................................. 2 8  
8. 2. 1.  
D ose Dela ys  ............................................................................................................................................. 2 8  
8. 2. 2.  
D ose Re d ucti o ns  ...................................................................................................................................... 2 8  
8. 2. 3.  
I nf usi o n I nterr u pti o ns .............................................................................................................................. 2 8  
8. 3.  
D ose -li miti n g t o xicit y ................................................................................................................................. 2 9  
8. 4.  
A d verse E ve nts  ........................................................................................................................................... 2 9  
8. 5.  
De a t hs ......................................................................................................................................................... 3 1  
8. 6.  
Cli nic al L a b or at or y Res ults  ...................................................................................................................... 3 2  
8. 7.  
Vit al Si g ns  ................................................................................................................................................... 3 2  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 4  of 4 6  
 
8. 8.  
E C O G Perf or m a nce St at us  ....................................................................................................................... 3 3  
8. 9.  
Electr o c a r di o gr a m ( E C G)  ......................................................................................................................... 3 3  
9.  
E X P L O R A T O R Y A N A L Y SI S  ........................................................................................ 3 3  
9. 1.  
Effic ac y a n al ysis b y de m o gr a p hic s u b gr o u ps  .......................................................................................... 3 3  
9. 2.  
C A -1 2 5 A n al ysis  ......................................................................................................................................... 3 3  
9. 3.  
Bi o m ar k ers/ P h ar m ac o d y n a mic A n al ysis  ................................................................................................. 3 4  
9. 4.  
I m m u n o ge nicit y A n al ysis .......................................................................................................................... 3 4  
9. 5.  
P h ar m ac o ki netic A n al ysis  ......................................................................................................................... 3 6  
9. 5. 1.  
P F -0 7 9 0 1 8 0 1 a n d P L D Ser u m C o nce ntrati o ns  ........................................................................................ 3 6  
9. 5. 2.  
P F -0 7 9 0 1 8 0 1 a n d P L D P har mac o ki netic Para meters  .............................................................................. 3 7  
1 0.  
R E F E R E N C E S  .................................................................................................................. 4 0  
1 1.  
A P P E N DI X 1:  T A B L E O F C O N T E N T O F T A B L E S, LI S TI N G S A N D FI G U R E S  4 1  
 
 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 5  of 4 6  
 
A B B R E VI A TI O N S  
A b bre vi ati o n  
Defi niti o n  
A D A  
A nti -dr u g A nti b o d y  
A E  
A d verse E ve nt  
A L T  
A la ni ne A mi n otra nsferase  
A N C  
A bs ol ute Ne utr o p hil C o u nt  
A S T  
A s partate A mi n otra nsferase  
B S A  
B o d y S urface Are a 
C DI S C  
Cli nical Data I nterc h a n ge Sta n dar ds C o ns orti u m  
CI  
C o nfi de n ce I nter val  
C M  
C o nc o mita nt Me dicati o ns  
C R  
C o m plete Res p o nse  
C R F  
Case Re p ort F or m  
C R O  
C o ntract Researc h Or ga nizati o n  
C S R  
Cli nical St u d y Re p ort  
C T C A E  
C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts  
D C R  
Disease C o ntr ol Rate  
D DI  
Dr u g -Dr u g I nteracti o n  
D L T  
D ose -Li miti n g T o xicit y  
D O R  
D urati o n of Res p o nse  
E C G  
Electr ocar di o gra m  
E C H O  
Ec h ocar di o gra m  
E C O G  
Easter n C o o perati ve O nc ol o g y Gr o u p  
e C R F  
Electr o nic Case Re p ort F or m  
E D C  
Electr o nic Data Ca pt ure  
E O C  
E pit helial O varia n C a ncer 
E O S  
E n d of St u d y  
E O T  
E n d of Treat me nt  
F D A  
U nite d States F o o d a n d Dr u g A d mi nistrati o n  
G C P  
G o o d Cli nical Practice  
G L P  
G o o d La b orat or y Practice  
h  
h o ur  
I C F 
I nf or me d C o nse nt F or m 
I C H 
I nter nati o nal C o u ncil f or Har m o nisati o n 
I R B 
I nstit uti o nal Re vie w B oar d 
I U 
I nter nati o nal U nits 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 6  of 4 6  
 
I V 
I ntra v e n o us 
L  
liter(s) 
m 2 
s q uare d meter(s) 
m A b  
m o n ocl o nal a nti b o d y  
Me d D R A  
Me dical Dicti o nar y f or Re g ulat or y Acti vities  
m g/ m L  
Milli gra ms per milliliter  
mi n  
mi n ute(s)  
M T D  
Ma xi m u m T olerate d D ose  
N A  
N ot A vaila ble  
N A b  
Ne utralizi n g a nti b o dies  
N CI  
Nati o nal Ca n cer I nstit ute  
N E  
N ot E val ua ble  
O R R  
O bjecti ve Res p o nse Rate  
O S  
O verall S ur vi val  
P D  
Pr o gressi ve Disease; P har mac o d y na mics  
P L D  
Pe g ylate d Li p os o mal D o x or u bici n  
P F S  
Pr o gressi o n -Free S ur vi val  
PI  
Pri n ci pal I n vesti gat or  
P K  
P har mac o ki netics  
P P  
Per Pr ot oc ol  
P R  
Partial Res p o nse  
P T  
Preferre d Ter m  
R E CI S T  
Res p o nse E val uati o n Criteria i n S oli d T u m ors  
S A E  
Seri o us A d verse E ve nt  
S A P  
Statistical A nal ysis Pla n  
S D  
Sta ble Disease  
S O C  
S yste m Or ga n Class  
S O P  
Sta n dar d O perati n g Pr o ce d ure  
T E A E  
Treat me nt E mer ge nt A d verse E ve nts  
T L F  
Ta bles, Listi n gs, a n d Fi g ures  
W H O  
W orl d Healt h Or ga nizati o n  
W H O -D D  
W orl d Healt h Or ga nizati o n Dr u g Dicti o nar y  
 
 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 7  of 4 6  
 
1.  IN T R O D U C TI O N  
1. 1.  Pr ot oc ol a n d A me n d me nt Hist or y  
T his Statistical A nal ysis Pla n ( S A P) is base d o n versi o n 2. 0 of Pr ot oc ol C 4 9 7 1 0 0 2 ( T TI -6 2 2 -0 2)  (0 7 D E C 2 0 2 2).  
Pr ot oc ol Versi o n  
A p pr o v al D ate  
1. 0  
2 8J U L 2 0 2 1  
2. 0  
0 7 D E C 2 0 2 2  
 
T he  st u d y pr ot oc ol descri bes t he ge neral a p pr oac h t o a nal ysis of data fr o m t he st u d y. T his S A P descri bes a d diti o nal 
detail nee de d t o c o m plete s uc h a n a n al ysis a n d will g o ver n t he fi nal a nal ysis of data fr o m t his st u d y.  T he pla n ma y be 
m o difie d pri or t o t he cli nical data b ase l oc k.  A n y de vi ati o ns fr o m t h is a nal ysis pla n, i ncl u di n g a n y after t he ti me of 
fi nal a n al ysis, will be d oc u me nte d as s uc h i n t he st u d y re p ort. 
1. 2.  C h a n ges t o Pl a n ne d A n al yses fr o m Pr ot oc ol  
N o c h a n ges t o t he pla n ne d a n al yses  i n t he pr ot oc ol are n ote d . 
1. 3.  Re visi o n Hist or y of t he St atistic al A n al ysis Pl a n 
Versi o n  
A p pr o v al D ate  
C h a n ges fr o m Pre vi o us Versi o n  
1. 0  
1 8 S E P 2 0 2 3  
n/a  
 
2.  S T U D Y  O B J E C TI V E S  
2. 1.  Pri m ar y  O bjecti ve  
T he pr ot oc ol  lists t he f oll o wi n g pri mar y o bjecti ves: 
 
- 
T o e v al uate d ose -li miti n g to xicit ies ( DL T), safet y a n d t olera bilit y of escalati n g d ose le vels of Ma plir p ace pt 
(P F -0 7 9 0 1 8 0 1 ) w he n a d mi nistere d i n c o m bi nati o n wit h 4 0 m g/ m 2 p e g ylate d li p os o mal d o x or u bici n  (P L D ) 
i n 2 8-da y c y cles a n d esta blis h t he m a xi m u m tolerate d d ose (M T D ) a n d rec o m me n de d p hase 2 d ose (R P 2 D ) 
c o m bi nati o n re gi me n ( P hase 1 p orti o n of st u d y)  
- 
T o assess a preli mi nar y e vi de nce of a nti -t u m or acti vit y of Ma plir p ace pt (P F -0 7 9 0 1 8 0 1 ) i n c o m bi nati o n wit h 
4 0 m g/ m 2 P L D ( P hase 2 p orti o n of st u d y)  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 8  of 4 6  
 
2. 2.  Sec o n d ar y O bjecti ve s 
T he pr ot oc o l lists t he f oll o wi n g sec o n dar y o bjecti ve s: 
- 
T o f urt her assess t he o verall safet y pr ofile of Ma plir p ace pt (P F -0 7 9 0 1 8 0 1 ) a d mi nistere d i n c o m bi nati o n 
wit h 4 0 m g/ m 2 P L D  
- 
T o assess a d diti o nal efficac y o utc o mes  
2. 3.  E x pl or at or y O bjecti ves  
T he pr ot oc ol  lists t he f oll o wi n g e x pl orat or y  o bjecti ve s: 
- 
T o assess effect of treat me nt wit h Ma plir p ace pt ( P F-0 7 9 0 1 8 0 1) i n c o m bi nati o n wit h P L D o n C A-1 2 5 le vels  
- 
T o c h aracterize t he Ma plir p ace pt ( P F-0 7 9 0 1 8 0 1) c o nce ntrati o n i n ser u m w he n a d mi nistere d i n c o m bi nati o n 
wit h P L D  
- 
T o c h aracterize t he P L D c o nce ntrati o n i n plas ma w he n a d mi nistere d i n c o m bi nati o n wit h P F -0 7 9 0 1 8 0 1  
- 
T o assess dr u g -dr u g i nteracti o n ( D DI) p ote ntial bet wee n Ma plir p ace pt ( P F-0 7 9 0 1 8 0 1) a n d P L D  
- 
T o e val uate de vel o p me nt of a nti b o dies directe d a gai nst Ma plir p ace pt ( PF -0 7 9 0 1 8 0 1)  
- 
T o e x pl ore p ossi ble relati o ns hi ps bet wee n Ma plir p ace pt ( P F-0 7 9 0 1 8 0 1) e x p os ure a n d cli nical o utc o me, 
safet y a n d p har mac o d y na mics o bser vati o ns. 
- 
T o u n dersta n d t he relati o ns hi p bet wee n t he t hera pe utic i nter ve nti o n(s) bei n g st u die d a n d t he bi ol o g y o f t he 
partici pa nt’s disease.  
 
3.  S T U D Y E N D P OI N T S  
3. 1.  Pri m ar y  E n d p oi nt  
T he pri mar y e n d p oi nt s are: 
- 
P hase 1: D L Ts d uri n g t he D L T o bser vati o n peri o d ( 2 8 da ys f oll o wi n g c ycle 1 da y 1)  
- 
P hase 2: O bjecti ve res p o nse ( C R, P R) as defi ne d b y R E CI S T v 1. 1 criteria  
3. 2.  Sec o n d ar y  E n d p oi nts  
T he pr ot oc ol descri bes as sec o n dar y e n d p oi nts t he f oll o wi n g:  
- 
O verall safet y pr ofile as assesse d b y t he t y pe, fre q ue nc y, se verit y, ti mi n g a n d ca usal relati o ns hi p of a n y 
a d verse e v e nts, c h a n ges i n vital si g ns, E C G, ser u m c he mistr y or ot he r la b orat or y assess me nt, treat me nt 
dela ys or disc o nti n uati o ns  
- 
P F S, O S, disease c o ntr ol ( D C [ C R or P R or S D]), a n d D O R  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 9  of 4 6  
 
3. 3.  E x pl or at or y  E n d p oi nts  
T he pr ot oc ol descri bes as e x pl orat or y e n d p oi nts t he f oll o wi n g : 
- 
C A -1 2 5 le vels i n serial bl o o d sa m ples  
- 
Meas ure me nts of  bi o mar kers/ p har mac o d y na mics, w hic h ma y c o nsist of D N A, R N A, pr otei n or defi ne d cell 
t y pes, res ulti n g fr o m a nal yses of peri p heral bl o o d a n d/ or t u m or tiss ue bi os peci me n o btai ne d at baseli ne, o n 
treat me nt a n d/ or at e n d of st u d y 
- 
I m m u n o ge nicit y: I nci de n ce a n d titers of A D A a n d ne utralizi n g a nti b o dies a gai nst P F-0 7 9 0 1 8 0 1  
- 
P F -0 7 9 0 1 8 0 1 P K: Si n gle a n d m ulti ple d ose C ma x , 
, C tr o u g h, a n d cleara nce  
- 
P L D P K: Si n gle a n d m ulti ple d ose C ma x  a n d C tr o u g h 
 
4.  S T U D Y D E SI G N  
4. 1.  Desi g n O ver vie w  
T his is a m ulti -ce nter, o pe n -la bel st u d y desi g ne d t o e val uate Ma plir p ace pt 
( P F-0 7 9 0 1 8 0 1) a d mi nistere d i n 
c o m bi nati o n wit h P L D i n  partici pa nts wit h plati n u m -resist a nt rec urre nt e pit helial o varia n ca ncer  (E O C ), i ncl u di n g 
o varia n, perit o neal a n d fall o pia n t u be mali g na n c y , a n d f or w h o m P L D is a reas o na ble treat me nt o pti o n.  T he st u d y will 
c o nsist of a 2 8 -da y scree ni n g peri o d, a treat me nt peri o d i n w hic h partici pa nts will recei ve P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n 
wit h P L D i n 2 8 -da y c ycles u ntil d oc u me ntati o n of o bjecti ve disease pr o gressi o n or de vel o p me nt of u nacce pta ble 
t o xicit y, an d a l o n g -ter m f oll o w-u p peri o d t o assess o verall s ur vi val.  
 
I n t he p hase 1 d ose escalati o n p orti o n of t he st u d y, t he pri mar y o bjecti ve is t o assess D L Ts, safet y a n d t olera bilit y of 
escalati n g d ose le vels of P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h P L D at t he sta n d ar d d ose of 4 0 m g/ m 2. U p t o 
a p pr o xi matel y 1 8 partici pa nts  are pla n ne d t o be e nr olle d i n t his p orti o n of t he st u d y t o e val uate  t hree d ose le vels of 
P F -0 7 9 0 1 8 0 1 1 2 m g/ k g ( D ose Le v el 1), 2 4  m g/ k g ( D ose Le vel 2) a n d 4 8 m g/ k g ( D ose Le vel 3). I n C ycle 1  f or d ose 
le vels 1 a n d 2, P F-0 7 9 0 1 8 0 1 will be a d mi nistere d o n Da y  1, Da y 8, Da y 1 5 , a n d Da y 2 2 i n c o m bi nati o n wit h P L D o n 
Da y 1  of 2 8 -da y c y cle. Be gi n ni n g wit h C ycle 2 at d ose le vels 1 a n d 2,  P F -0 7 9 0 1 8 0 1 will be a d mi nistere d o n Da y 1 
a n d Da y 1 5 i n  c o m bi nati o n wit h P L D o n Da y 1 of 2 8 -da y c ycles. T he e n ha nce d  d osi n g i n C ycle 1 re prese nts a l oa di n g 
c y cle a n d is i nte n de d t o  all o w P F-0 7 9 0 1 8 0 1 le vels t o reac h stea d y state m ore q uic kl y. F or d ose le vel 3, P F -0 7 9 0 1 8 0 1 
will be a d mi nistere d o n Da y 1 a n d  Da y 1 5 i n c o m bi nati o n w it h P L D o n Da y 1 of 2 8-da y c ycles.  L oa di n g d oses ( Da y 
8 a n d Da y 2 2) ma y be c o nsi dere d f or C ycle 1  at t he 4 8 m g/ k g d ose ( D ose L e vel 3) if f o u n d t o be safe a n d offer cli nical 
be n efit f or partici pa nts. If C ycle 1 l oa di n g d oses are i m ple me nte d, all d osi n g a n d la b dra w sc he d ules f or t he 4 8 m g/ k g 
d ose will f oll o w t he sc h e d ules f or d ose le vels 1 2 m g/ k g a n d 2 4 m g/ k g.  
O ne d ose le vel c o m bi nati o n will be selecte d f or f urt her e val uati o n i n t he p hase 2 e x pa nsi o n p orti o n of t he st u d y. T he 
pri mar y o bjecti ve of t he p hase 2  e x pa nsi o n p orti o n of t he st u d y is i n vesti gati o n of cli nical acti vit y of t he c o m bi nati o n 
of P L D a n d P F -0 7 9 0 1 8 0 1, assesse d usi n g t he o verall res p o nse b y R E CI S T v 1. 1.  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)
C CI


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 0  of 4 6  
 
4. 2.  S a m ple Size  
I n t he P hase 1 d ose escalati o n p hase of t he st u d y, t he n u m ber of partici pa nts will de pe n d o n t he n u m ber of d ose c o h orts 
t hat will be e nr olle d bef ore reac hi n g t he M T D. It is a ntici pate d t hat t he st u d y will e val uate t hree d ose le vels of P F-
0 7 9 0 1 8 0 1 gi ve n i n c o m bi nati o n wit h a fi xe d d ose of P L D. O n t he basis of e mer gi n g safet y a n d/ or cl i nical acti vit y 
data, a d diti o nal d ose le vels ma y be a d de d. T he size a n d desi g n of t he p hase 1 is c o nsiste nt wit h sta n dar d 3 + 3 desi g n 
wit h t he o bjecti ve of deter mi ni n g t he safet y of escalati n g d oses of P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h fi xe d -d ose P L D 
a n d establis hi n g P F -0 7 9 0 1 8 0 1 d oses f or f urt her e val uati o n i n t he i nte n de d partici pa nt p o p ulati o n. Base d o n a sta n dar d 
3 + 3 desi g n, u p t o a p pr o xi matel y si x D L T -e val ua ble partici pa nts ma y be e nr olle d i n eac h d ose le vel c o h ort d uri n g t he 
p hase 1; a mi ni m u m of ni ne a n d  a ma xi m u m of 1 8 D L T -e val ua ble partici pa nts is a ntici pate d.  
 
I n t he p hase 2 e x pa nsi o n p hase of t he st u d y, a c o h ort is pla n ne d t o e val uate a selecte d P F -0 7 9 0 1 8 0 1 d ose le vel i n  
c o m bi nati o n wit h a fi xe d d ose of P L D. I n t his h y p ot hesis -ge nerati n g st u d y, ass u mi n g a n  o bjecti ve res p o nse rate of 
1 0 % wit h P L D m o n ot hera p y a n d a n alter nati ve of 3 0 %, a p o wer of  8 0 % a n d o ne -si de d ty pe 1 err or set at 0. 0 5, t he 
c o m bi nati o n will be c o nsi dere d w ort h y of  f urt her st u d y if at least si x res p o nses are o bser ve d a 2 5  treate d parti ci pa nt 
c o h ort. If t he d ose le vel  c o m bi nati o n selecte d f or f urt her p hase 2 is deter mi ne d t o be n ot o pti mal or n ot well t olerate d,  
a n i nter me diate d ose le vel, n ot t o e xcee d t he d ose le vels e val uate d i n p hase 1, ma y be  i m ple me nte d. S ec o n dar y 
e n d p oi nts, s uc h as disease c o ntr ol, d urati o n of res p o nse, pr o gressi o n -free s ur vi val a n d o verall s ur vi val will be a n al yze d 
descri pti vel y.  
 
5.  G E N E R A L A N A L Y TI C A L C O N SI D E R A TI O N S  
5. 1.  D at a S o urces  
All re p orte d st u d y data will be rec or de d o n t he electr o nic case re p ort f or ms (e C R F) usi n g Me di data Ra ve. D uri n g 
t he data c ollecti o n pr ocess, a ut o mate d q ualit y ass ura nce pr o gra ms will be use d t o i de ntif y missi n g data, o ut-of -ra n ge 
data, a n d ot her data i nc o nsiste ncies. La b data (c he mistr y a n d he mat ol o g y) will c o me fr o m l ocal la bs t hr o u g h t he 
E D C.  
5. 2.  Defi niti o n of B aseli ne  
Baseli ne is defi ne d as t he last meas ure me nt ta ke n pri or t o t he first i nf usi o n of st u d y me dicati o n ( C ycle 1 Da y 1). If 
a n assess me nt is pla n ne d t o be perf or me d pri or t o t he first d ose of st u d y treat me nt i n t he pr ot oc ol a n d t he assess me nt 
is perf or me d o n t he sa me da y as t he first d ose of st u d y treat me nt, it will be ass u me d t hat it was perf or me d pri or t o 
st u d y treat me nt a d mi nistrati o n, if assess me nt ti me p oi nt is n ot c ollecte d or is missi n g.  
 
T he a v era ge of t he pre -i nf usi o n res ults will be c o nsi dere d as t he baseli ne val ue f or vital si g ns ta ke n at differe nt 
ti me p oi nts o n t he sa me pre-i nf usi o n da y. 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 1  of 4 6  
 
5. 3.  A n al ysis Visit s a n d Wi n d o w s 
T he partici pati o n i n t he st u d y i ncl u des t he f oll o wi n g pla n ne d visits ( wi n d o w)  wit h res pect to  t he first d ose  of st u d y 
treat me nt: 
•  
Scree ni n g Visit ( Da y -2 8 t o -1)  
•  
C ycle 1: Da y 1, Da y 8 , Da y 1 5, a n d Da y 2 2  
•  
C ycle 2  a n d 3 : Da y 1, Da y 8, Da y 1 5, a n d Da y 2 2  ( ±3 ) 
•  
C ycle 4 a n d s u bse q ue nt c ycles : Da y 1, a n d Da y 1 5  ( ±3 ) 
•  
E n d of Treat me nt (7 ± 3 da ys after last a d mi nistrati o n of st u d y treat me nt) 
•  
Safet y F oll o w -U p  (3 0 + 5  da ys after last a d mi nistrati o n of st u d y treat me nt)  
•  
L o n g -Ter m F oll o w -U p  (assesse d e ver y 1 2 ± 2 wee ks ) 
 
T he pr ot oc ol pr o vi des a d diti o nal details i n ta ble 2 8. Sc he d ule of Assess me nt . Ti me p oi nts a n d its wi n d o ws f or P K 
a n al ysis of P F -0 7 9 0 1 8 0 1 a n d P L D c o nce ntrati o ns  are descri be d i n secti o n 1 0 of t his S A P, a n d i n ta bles 2 9 a n d 3 0 of 
t he pr ot oc ol. 
 
I n case of o ut-of -wi n d o w visits, t hese data will be a nal yze d se paratel y at t he ti me t he i n p ut as rec or d e d. 
5. 4.  Missi n g D at a  
D ue t o t he st u d y desi g n, data will be re p orte d as c ollecte d a n d n o i m p utati o n met h o ds of missi n g val ues will be 
perf or me d, e x ce pt f or partial dates. Bel o w it is a d dresse d h o w missi n g i nf or mati o n will be ha n dle d f or partial / missi n g 
dates a n d i nc o m plete disease assess me nts.  
5. 4. 1.  P arti al a n d Missi n g D ates  
Partial dates are all o we d o n t he e C R F f or pri or disease t hera p y start a n d st o p dates, a d verse e ve nt ( A E) o nset a n d e n d 
dates, c o nc o mita nt me dicati o n start a n d st o p dates, a n d c o nc o mita nt pr oce d ure , pr oce d ure dates. A n e ntr y f or t he year 
is re q uire d i n t he e C R F s yste m f or eac h of t hese dates. O nl y t he m o nt h a n d da y ma y be e ntere d as u n k n o w n. Dates 
fr o m t hese f or ms will be re p orte d i n listi n gs as c ollecte d. E ver y eff ort will be ma de t o q uer y missi n g dates.  T he 
f oll o wi n g r ules will b e use d f or i m p utati o n of partial a n d missi n g A E dates:  
 
- 
A E o nset dates wit h missi n g da y a n d n o n -missi n g m o nt h will be ass u me d t o occ ur o n t he first d a y 
of t he n o n -missi n g m o nt h, e xce pt f or A Es occ urri n g i n t he m o nt h a n d yea r of first d osi n g, i n w hic h 
case t he date will be i m p ute d usi n g t he date of first d osi n g.  
- 
A E o nset dates wit h missi n g da y a n d m o nt h will be ass u m e d t o occ ur o n t he first da y of t he n o n -
missi n g year (i.e., Ja n uar y 1), e xce pt f or A Es occ urri n g i n t he year o f first d osi n g, i n w hic h case 
t he date will be i m p ute d usi n g t he date of t he first d osi n g. 
- 
A Es t hat are n ot o n g oi n g a n d ha ve a n e n d date wit h missi n g da y a n d n o n -missi n g m o nt h, t he y will 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 2  of 4 6  
 
be ass u me d t o occ ur o n t he last da y of t he m o nt h, e xce pt w he n t he e n d  of st u d y date or date of 
deat h is pri or t o t he last da y of t he m o nt h. T he date will be i m p ute d as e n d of st u d y date, or deat h 
date, w hic he v er ha p pe ns t he earliest.  
- 
A Es t hat are n ot o n g oi n g a n d ha ve missi n g m o nt h i n t he e n d date, t he i m p ute d e n d date s h o ul d be 
set t o t he last da y of t he year (3 1 D E C Y Y Y Y ), e xce pt w he n t he e n d of st u d y date or date of deat h 
is pri or t o t he last da y of t he year. T he date will be i m p ute d as e n d of st u d y date, or deat h date, 
w hic he v er ha p pe ns t he earliest.  
 
F or rec or ds wit h missi n g A E o nset date, t he f oll o wi n g pr oce d ure will be e m pl o ye d f or use i n deter mi ni n g w het her t he 
A E is treat me nt -e mer ge nt: 
St a rt D ate  
E n d D ate  
R ule  
K n o w n  
K n o w n  
If start date < st u d y me dicati o n start date, t he n n o n -T E A E ; 
If start date ≥ st u d y me dicati o n start date, t he n T E A E 
Partial  
Missi n g  
 
Partial ( k n o w n parts i n dicati n g 
A E are n ot o n or after st u d y 
me dicati o n start d ate) 
K n o w n  
N o n -T E A E  
Partial  
Missi n g  
 
Partial ( k n o w n parts i n dicati n g 
A E are o n or after st u d y 
me dicati o n start d ate) 
 
O R  
 
Missi n g  
K n o w n  
If e n d  date < st u d y me dicati o n start date, t he n n o n -T E A E ; 
If e n d  date ≥ st u d y me dicati o n start date, t he n T E A E 
Partial  
Ass u me  e n d  date as latest p ossi ble d ate (i.e., last da y of m o nt h 
if da y u n k n o w n or 3 1st Dece m ber if da y a n d m o nt h are 
u n k n o w n), t he n:  
If e n d  date < st u d y me dicati o n start date, t he n n o n -T E A E ; 
If e n d  date ≥ st u d y me dicati o n start date, t he n T E A E 
Missi n g  
T E A E  
 
F or rec or ds wit h a missi n g me dicati o n start a n d/ or st o p date, t he f oll o wi n g date i m p utati o n r ule will be a p plie d : 
•  
Me dicati o n start d ates wit h a missi n g da y a n d n o n -missi n g m o nt h will be ass u me d t o occ ur o n t he 
first da y of t he n o n-missi n g m o nt h, e xce pt f or me dicati o ns occ urri n g i n t he m o nt h of first d osi n g, 
i n w hic h case t he date will be t he date of first d osi n g. 
•  
Me dicati o n start dates wit h missi n g da y a n d m o nt h will be ass u me d t o occ ur o n t he first da y of t he 
n o n -missi n g year (i.e., Ja n uar y 1), e xce pt f or me dicati o ns occ urri n g i n t he year of first d osi n g, i n 
w hic h case t he date will be t he date of first d osi n g.  
•  
Me dicati o ns t hat are n ot o n g oi n g a n d ha ve a me dicati o n st o p date wit h a missi n g da y a n d n o n -
missi n g m o nt h will be ass u me d t o occ ur o n t he last da y of t he n o n-missi n g m o nt h.  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 3  of 4 6  
 
•  
Me dicati o ns t hat are n ot o n g oi n g a n d ha ve a me dicati o n st o p date wit h missi n g da y a n d m o nt h will 
be ass u me d t o occ ur o n t he last da y of t he n o n -missi n g year (i.e., Dece m ber 3 1).  
 
T he f oll o wi n g al g orit h m will be e m pl o ye d f or deter mi ni n g w het her t he me dicati o n is pri or or c o nc o mita nt:  
St a rt D ate  
E n d D ate  
R ule  
K n o w n/  
Partial/  
Missi n g  
K n o w n  
 
If e n d  date < st u d y me dicati o n start date, t he n pri or; 
If e n d  date ≥ st u d y me dicati o n start date, t he n c o nc o mita nt  
Partial  
Ass u me  e n d  date as latest p ossi ble date (i.e., last da y of m o nt h if 
da y u n k n o w n or 3 1 st Dece m ber if da y a n d m o nt h are u n k n o w n), 
t he n: 
If e n d  date < st u d y me dicati o n start date, t he n pri or ; 
If e n d  date ≥ st u d y me dicati o n start date, t he n c o nc o mita nt 
Missi n g  
C o nc o mita nt  
 
F or rec or ds wit h a missi n g pr oce d ure date, t he f oll o wi n g pr oce d ure will be e m pl o ye d f or use i n deter mi ni n g w het her 
t he pr oce d ure is pri or or c o nc o mita nt: 
•  
Pr o ce d ure dates wit h a missi n g da y a n d n o n -missi n g m o nt h will be ass u me d t o occ ur o n t he first 
da y of t he n o n -missi n g m o nt h, e xce pt f or pr oce d ures occ urri n g i n t he m o nt h of first d osi n g, i n 
w hic h case t he date will be t he date of first d osi n g.  
•  
Pr o ce d ure dates wit h missi n g da y a n d m o nt h will be ass u me d t o occ ur o n t he fi rst da y of t he n o n-
missi n g year (i.e., Ja n uar y 1), e xce pt f or pr oce d ures occ urri n g i n t he year of first d osi n g, i n w hic h 
case t he date will be t he date of first d osi n g.  
 
F or rec or ds wit h a missi n g disease pr o gressi o n date fr o m pri or t hera p y, t he f oll o wi n g pr oce d ure will be e m pl o ye d f or 
use i n a n al yzi n g ti me t o e v e nt e n d p oi nts:  
•  
If t he disease pr o gressi o n date is c o m pletel y missi n g O R o nl y t he year is a vaila ble, set as missi n g. 
•  
If b ot h year a n d m o nt h of disease pr o gressi o n date fr o m are a vaila ble a n d o nl y da y is missi n g, t he 
date of disease pr o gressi o n will be i m p ute d b y t he last da y of t he m o nt h.  
 
F or rec or ds wit h a partial deat h date, the deat h date will be i m p ute d b y t he earliest p ossi ble date t hat is n ot c o ntra dicti n g 
wit h a n y ot her a v aila ble data i n t h e data b ase. 
5. 4. 2.  E x p os ure  
N o i m p utati o n will be d o ne f or first d ose date. Date of last d ose of st u d y dr u g, if u n k n o w n or partiall y u n k n o w n, will 
be i m p ute d as f oll o ws:  
• If t he last date of st u d y dr u g is c o m pletel y missi n g a n d t here is n o E n d of Treat me nt e C R F pa ge a n d n o 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 4  of 4 6  
 
deat h date, t he partici pa nt s h o ul d be c o nsi dere d t o be o n g oi n g a n d use t he c ut -off date f or t he a nal ysis as t he 
last d osi n g date 
• If t he last date of st u d y dr u g is c o m pletel y or partiall y missi n g a n d t here is EI T H E R a n E n d of Treat me nt 
e C R F pa ge O R a deat h date a vaila ble ( wit hi n t he c ut -off date), t he n i m p ute d last d ose date is:  
•  
= 3 1 D E C Y Y Y Y, if o nl y Year is a vaila ble a n d Year < Year of mi n ( E O T date, deat h date)  
•  
= Last da y of t he m o nt h, if b ot h Year a n d M o nt h are a vaila ble a n d Year = Year of mi n ( E O T date,  
deat h date) a n d M o nt h < t he m o nt h of mi n ( E O T date, deat h date)  
•  
= mi n ( E O T date, deat h date), f or all ot her cases.  
5. 4. 3.  L ast K n o w n Ali ve D ate  
T he last k n o w n ali ve date will be deri ve d f or partici pa nts n ot k n o w n t o ha ve die d at t he ti me of a nal ysis usi n g t he 
latest c o m plete date a m o n g t he f oll o wi n g: 
•  
All patie nt assess me nt dates ( bl o o d dra ws (la b orat or y, P K), vital si g ns, perf or ma nce stat us, E C G, t u m or 
assess me nts)  
•  
Start a n d e n d dates of a nti -ca ncer t hera pies a d mi nistere d after st u d y treat me n t disc o nti n uati o n 
•  
A E start a n d e n d dates  
•  
Last date c ollecte d o n t he ‘ S ur vi val stat us’ e C R F  
•  
St u d y dr u g start a n d e n d dates  
•  
Wit h dra wal of c o nse nt d ate  
•  
Date of treat me nt or st u d y disc o nti n uati o n ( d o n ot use if reas o n f or disc o nti n uati o n is l ost t o f oll o w -u p).  
 
O nl y dates ass ociate d wit h act ual e x a mi nati o ns of t he partici pa nt will be use d i n t he deri vati o n. Dates ass ociate d wit h 
a tec h nical o perati o n u nrelate d t o partici pa nt stat us s uc h as t he date a bl o o d sa m ple was pr ocesse d will n ot be use d. 
Assess me nt d ates after t he c ut -off date will n ot be a p plie d t o deri ve t he last c o ntact date.  
5. 5.  Ti mi n g of A n al yses  
T his is a n e x pl orat or y  st u d y, s o a n al yses ma y be perf or me d as t he st u d y pr o gresses, s uc h as f or t he trial p hase 2 
tra nsiti o n. Efficac y a n d safety a n al ysis f or safet y re vie w/e val uati o n, a n d/ or p u blicati o n p ur p oses mi g ht be pr o d uce d 
bef ore t he fi nal a n al ysis  (e. g. re p orti n g f or P hase 1 a n d P hase 2 , se paratel y). 
5. 6.  A n al ysis P o p ul ati o ns  
5. 6. 1.  S afet y A n al ysis Set ( S A S)  
T he safet y a nal ysis set will i ncl u de parti ci pa nts w h o were e nr olle d a n d recei ve d at least o ne d ose of P F -0 7 9 0 1 8 0 1 . 
T his a n al ysis p o p ulati o n will be  t he pri mar y p o p ulati o n f or t he a nal ysis of safet y a n d efficac y e n d p oi nts.  F or re p orti n g 
res p o nse rate pri or t o st u d y c o m pleti o n, t he a nal ysis p o p ulati o n will i ncl u de all patie nts wit h a baseli ne disease 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 5  of 4 6  
 
assess me nt, a f oll o w -u p assess me nt  at least 4  wee ks after t he first d ose a n d partici pa nts w h o ha ve disc o nti n ue d t he 
st u d y f or a n y reas o n. 
 
I n P hase 1, eac h partici pa nt will be classifie d t o a d ose c o h ort if t he i nitiall y pla n ne d P F -0 7 9 0 1 8 0 1 d ose was 
recei ve d at least o nce  a n y ti me o n st u d y . If t he i nitiall y pla n ne d d ose is ne ver recei ve d b y a partici pa nt, t he n t he 
partici pa nt will be classifie d t o t he c o h ort base d o n hi g hest P F -0 7 9 0 1 8 0 1 d ose  recei ve d.  
 
F or partici pa nts  w h o recei ve d a wr o n g st u d y d ose, t he y w o ul d be rec o de d as pr ot oc ol de viati o n, as descri be d i n 
secti o n 6. 3.  
5. 6. 2.  D L T -E v al u a ble P o p ul ati o n ( D L P)  
T he D L T -e v al ua ble p o p ulati o n is a p plica ble t o p hase 1 d ose -escalati o n partici pa nts o nl y  w h o eit her e x perie nce D L T 
after at least o ne d ose of P F -0 7 9 0 1 8 0 1  or di d n ot e x perie nce a D L T a n d recei ve d t he f ull d ose of P L D , at least t w o 
i nf usi o ns of P F-0 7 9 0 1 8 0 1 a n d c o m plete d safet y e val uati o ns d uri n g t he 2 8 -da y C ycle 1 D L T peri o d.  
5. 6. 3.  P F -0 7 9 0 1 8 0 1 / P L D C o nce ntr ati o n A n al ysis P o p ul ati o n ( P C P)  
T he P C P will i ncl u de partici pa nts  w h o recei ve d at least o ne d ose of P F -0 7 9 0 1 8 0 1  a n d/or P L D a n d ha ve at least o ne 
e v al ua ble bl o o d sa m ple f or a nal ysis c ollecte d.  
5. 6. 4.  I m m u n o ge nicit y A n al ysis P o p ul ati o n (I A P) 
T he I A P will i n cl u de partici pa nts  w h o recei ve d at least o ne d ose of P F -0 7 9 0 1 8 0 1 a n d wit h at least 1 a nti-P F -
0 7 9 0 1 8 0 1 a nti b o d y ( A D A) a n d ne utralizi n g a nti -P F -0 7 9 0 1 8 0 1 a nti b o d y ( N A b) sa m ple a nal yze d  ( pre-d ose or p ost -
treat me nt). 
 
If a s u bject has o nl y pre -d ose assess me nt a n d n o p ost -treat me nt i m m u n o ge nicit y data, t his s u bject is n ot e val ua ble 
f or s u bject-le vel A D A a n d N A b e v al uati o n , a n d s h o ul d n ot be i ncl u de d i n s u bject-le vel data a nal ysis (e. g.,  o verall 
A D A/ N A b i nci de n ce, d urati o n of A D A/ N A b res p o nse).  
5. 6. 5.  P h ar m ac o d y n a mics A n al ysis P o p ul ati o n ( P D P)  
T he P D P will i ncl u de partici pa nts  w h o recei ve d at least o ne d ose of P F -0 7 9 0 1 8 0 1 a n d ha ve at least o ne e val ua ble 
bl o o d sa m ple c ollecte d f or s pecific bi o mar ker a n d p har mac o d y na mic s a nal ysis ( pre-d ose or p ost -treat me nt). 
 
If a s u bject has o nl y pre -d ose assess me nt a n d n o p ost -treat me nt bi o mar ker s a n d p har mac o d y na mic s data, t his s u bject 
is n ot e val ua ble f or s u bject-le vel e v al uati o n, a n d s h o ul d n ot be i ncl u de d i n t he s u bject -le vel data a nal ysis. 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 6  of 4 6  
 
5. 7.  D at a Dis pl a y C h ar acteristics  
Dat a dis pla ys pr o d uce d f or t his st u d y will i ncl u de t hree t y pes — s u m mar y ta bles, data listi n gs, a n d fi g ures. S u m mar y 
ta bles a n d fi g ures will b e pr o d uce d w he n s pecifie d i n secti o ns t o f oll o w. 
 
Data listi n gs will list t he data rec or de d o n t he C R F or deri ve d f or e ac h s u bject.  As nee de d, t he y ca n be pr o d uce d b y 
d ose c o h ort, site, s u bject n u m ber, a n d ti me of assess me nt, a n d a d diti o nal le vels of or deri n g hierarc h y ma y reflect 
s u bsets of assess me nts wit hi n s u bject.  S u bject-le vel i de ntifiers a p pear o n t he first li ne of data, a n d i de ntifiers f or 
s u b gr o u ps wit hi n s u bject a p pear o nl y o n t he first li ne of eac h s u b gr o u p val ue.  
 
Ta bles will dis pla y s u m mar y statistics calc ulate d f or eac h d ose c o h orts per st u d y p hase (escalati o n/e x pa nsi o n), u nless 
descri be d ot her wise i n t he f o ll o wi n g secti o ns. F or m ost s u m mar y ta bles, t he d ose gr o u p will be prese nte d i n c ol u m ns 
a n d t he s u m mar y statistics of i nterest will b e prese nte d i n r o ws.  
 
T he s u m mar y statistics dis pla ye d will be a f u ncti o n of t he t y pe of data ass ociate d wit h t he s u m marize d assess me nt.  
U nless state d ot her wise i n rele v a nt secti o ns t o f oll o w, c o nti n u o us data will be s u m marize d wit h t he n u m ber of n o n -
missi n g val ues, mea n, sta n dar d de viati o n, mi ni m u m, me dia n, a n d ma xi m u m.  Cate g orical data will be s u m marize d 
wit h t he n u m ber of  n o n -missi n g val ues a n d t he n u m bers of val ues e q ual t o eac h of t he p ossi ble val ues.  Perce nta ges 
of s u bjects wit h eac h of t he p ossi ble val ues will be calc ulate d fr o m t he n u m ber of s u bjects i n t he c orres p o n di n g 
a n al ysis p o p ulati o n, u nless st ate d ot her wise, a n d t h ose perce nta ges will be prese nte d wit h o ne deci mal ( X X. X %). 
S o me c o nti n u o us varia bles ma y als o be gr o u pe d i nt o cate g orical le vels a n d e val uate d i n fre q ue nc y ta bles.  
 
Dates i n t he cli nical data b ase are classifie d i nt o t he cate g ories of pr oce d ure dates , l o g dates, milest o ne dates, o utc o me 
dates, a n d s pecial dates:  
•  
Pr o ce d ure Dates ( T A R G E T D A T E): Dates o n w hic h gi ve n pr ot oc ol -s pecifie d pr oce d ure are 
perf or me d.  T he y i ncl u de t he dates of la b orat or y testi n g, p h ysical e xa mi nati o ns, disease 
assess me nts, etc. T he y s h o ul d be prese nt w he ne ver data f or a pr ot oc ol -s pecifie d pr oce d ure is 
prese nt a n d s h o ul d o nl y be missi n g w he n a pr oce d ure is mar ke d as N O T D O N E i n t he data base.  
Pr o ce d ure dates will n ot b e i m p ute d.  
•  
L o g Dates: Dates rec or de d i n C R F data l o gs.  S pecifi call y, t he y are t he start a n d e n d dates f or 
a d verse e v e nts a n d c o nc o mita nt me dicati o ns/ pr oce d ures. T he y s h o ul d n ot be missi n g u nless a n 
e v e nt or me dicati o n is mar ke d as o n g oi n g i n t he data b ase.  Ot her wise, i nc o m plete l o g dates will be 
i m p ute d acc or di n g t o t he r ules i n Secti o n 5. 4. 1 a b o ve. H o we ver, i n listi n gs, l o g dates will be s h o w n 
as rec or de d wit h o ut i m p utati o n.  
•  
Milest o ne Dates: Dates of pr ot oc ol milest o nes s uc h as st u d y dr u g start date, st u d y dr u g ter mi nati o n 
date, st u d y cl os ure date, etc.  T he y s h o ul d n ot be missi n g if t he milest o ne occ urs f or a s u bject.  
T he y will n ot b e i m p ute d.  
•  
O utc o me Dates: Dates c orres p o n di n g t o st u d y e n d p oi nts s uc h as s ur vi val, pr o gressi o n, etc.  I n m ost 
cases, t he y are deri ve d eit her fr o m a milest o ne (e. g., t he s ur vi val date is deri ve d fr o m t he deat h 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 7  of 4 6  
 
date), or a pr oce d ure date (e. g., t he pr o gressi o n date is deri ve d fr o m t he date of t he t u m or sca n t hat 
was use d t o deter mi ne pr o gressi o n).  T he y ma y be s u bject t o e n d p oi nt -s pecific ce ns ori n g r ules if 
t he o utc o me di d n ot o cc ur b ut are n ot ot her wise s u bject t o i m p utati o n.  
•  
S pecial Dates: Dates t hat ca n n ot be classifie d i n a n y of t he a b o ve cate g ories a n d t he y i ncl u de t he 
date of birt h. T he y ma y be s u bject t o varia ble -s pecific ce ns ori n g a n d i m p utati o n r ules. 
 
Calc ulati o ns usi n g dates (e. g. , s u bject’s a g e or relati ve da y after t he first d ose of st u d y me dicati o n) will a d here t o t he 
f oll o wi n g c o n ve nti o ns:  
•  
Trial Da y 1 of C ycle 1 is defi ne d as t he da y o n w hic h t he d ose of P L D a n d  P F -0 7 9 0 1 8 0 1  is 
a d mi nistere d after scree ni n g. St u d y da ys after tri al da y 1 will be calc ulate d as t he differe n ce 
bet wee n t he date of i nterest a n d t he first date of d osi n g of st u d y me dicati o n pl us 1 da y. T he 
ge n eralize d calc ulati o n al g orit h m f or relati ve da y: S T U D Y D A Y = [( T A R G E T D A T E –  D S T A R T) 
+ 1 w here D S T A R T = t he start  da y of st u d y dr u g].   
•  
F or dates of i nterest bef ore t he first date of d osi n g of st u d y me dicati o n, t he st u d y da y will be 
calc ulate d as: S T U D Y D A Y = T A R G E T D A T E –  D S T A R T. Ne g ati ve st u d y da ys are reflecti ve of 
o bser vati o ns o btai ne d pri or t o first st u d y dr u g a d mi nistrati o n.  N ote: P artial date f or t he first st u d y 
dr u g is n ot i m p ute d i n ge n eral. All eff ort s h o ul d be trie d t o a v oi d i nc o m plete st u d y dr u g start d ate.  
•  
A ge ( years) at i nf or me d c o nse nt will be calc ulate d as: ( Date of i nf or me d c o nse nt –  date of birt h + 
1) / 3 6 5. 2 5, a n d t he n tr u ncate d t o a n i nte ger. I n case of partial birt h date: i m p ute missi n g da y as 
1 5 t h of t he m o nt h; i m p ute missi n g m o nt h as J ul y ( 7 t h m o nt h); set missi n g a ge i n case of missi n g 
year.  
•  
D urati o n will be calc ulate d b y t he differe nce of start a n d st o p date + 1. A E  d urati o n ( da ys) = A E 
e n d date –  A E start d ate + 1  
•  
St u d y dr u g e x p os ure d urati o n ( wee ks) is detaile d i n secti o n 8. 1 . E x p os ure. 
•  
Ti me si nce disease dia g n osis ( m o nt hs) will be calc ulate d as (I nf or me d C o nse nt Date –  Dia g n osis 
Date + 1) / 3 0. 4 1 6 7.  
•  
T he ti me t o e v e nt will be calc ulate d as date of e ve nt mi n us refere nce date + 1. T he s pecific 
ce ns ori n g r ules o n ti me t o e ve nt e n d p oi nts will f oll o w Secti o n 7. 1. 1. S ec o n dar y Efficac y O utc o me 
A nal ysis , a n d Secti o n 8. 7. E C O G P erf or ma nce S tat us.  
•  
T he f oll o wi n g  c o n versi o n fact ors will be use d t o c o n vert da ys t o m o nt hs or years:  
o  
1 m o nt h = 3 0. 4 1 6 7 da ys  
o  
1 wee k = 7 da ys  
o  
1 year = 3 6 5. 2 5 da ys  
5. 7. 1.  M ulti ple Assess me nts f or t he S a me Assess m e nt Ti m e P oi nt  
I n t he case of m ulti ple o bser vati o ns (e. g., sc he d ule d vs. u nsc he d ule d) at a s pecific visit, t he first n o n -missi n g 
meas ure me nt will be use d f or a n al ysis, u nless m ulti ple st u d y assess me nts are e x pecte d (e. g., pre -d ose vs. p ost -d ose). 
W he n m ulti ple st u d y assess me nts are e x pecte d  (e. g. E C G) , t he a vera ge of t he re plicate meas ure me nts s h o ul d be 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 8  of 4 6  
 
deter mi ne d after t he deri vati o n of t he i n di vi d ual para meter at sa me ti me p oi nt. 
5. 8.  S oft w are Versi o n  
All statistical a n al yses will be c o n d ucte d usi n g S A S ® versi o n 9. 4 or hi g her ( S A S I nstit ute, I nc., Car y, N ort h Car oli na).  
 
N o n -c o m part me ntal  P k para meter calc ulati o ns will be perf or me d usi n g P h oe ni x ® Wi n N o nli n ® 8. 3 or hi g her ( Certara, 
Pri n cet o n, Ne w Jerse y). Gra p hics ma y be pre pare d usi n g t he sa me versi o ns of S A S ®, a n d/ or P h oe ni x Wi n N o nli n).  
 
6.  S U B J E C T A C C O U N T A BI LI T Y  
6. 1.  S u bject C h ar acteristics  
S u bj ect c h aracteristics will be s u m marize d b y p hase ( d ose escalati o n a n d e x pa nsi o n p hase) a n d b y d ose c o h ort, base d 
o n t he S A S , w hic h c o nsist of all partici pa nts w h o recei ve d at least o ne d ose of st u d y treat me nt.  
6. 1. 1.  De m o gr a p h y  
Data c ollecte d a b o ut t he f oll o wi n g s u bject c h aracteristics at t he scree ni n g visit will be s u m marize d:  
•  
A ge (i n years). A ge will be calc ulate d as t he n u m ber of years ela pse d bet wee n birt h date a n d t he 
date of t he scree ni n g visit.  
•  
A ge strata:  
o  
< 6 5  years  
o  
> = 6 5 years  
o  
6 5  - 7 4  years  
o  
7 5 - 8 4  years  
o  
≥ 8 5 years  
•  
Se x  
•  
Race. If m ore t ha n o ne race selecte d, s u m marize race as m ulti ple.  
•  
Et h nicit y  
•  
Hei g ht  
•  
Wei g ht  
•  
B S A  
•  
E C O G  
•  
N u m ber of pri or re gi me ns ( 1 vs 2 , 3 or 4 )  
•  
Disease sta ge  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 1 9  of 4 6  
 
6. 1. 2.  Me dic al Hist or y  
Me dical hist ories will be s u m marize d as t he n u m bers a n d perce nta ges of s u bjects wit h hist ories si g nifica nt f or eac h 
of t he me dical -hist or y ele m e nts rec or de d o n t he M e dical H ist or y ( M H) C R F f or m. C o di n g will be perf or me d usi n g 
Me dical Dicti o nar y f or Re g ulat or y Acti vities ( Me d D R A), latest versi o n. S yste m Or ga n Cl ass ( S O C) a n d Preferre d 
Ter m ( P T) will be s u m marize d b y n u m ber a n d perce nta ge of partici pa nts  ha vi n g at least o ne occ urre nce of a disease. 
All M H i nf or mati o n, i ncl u di n g dia g n osis a n d start/e n d date will be liste d f or t he S A S .  
6. 1. 3.  C a ncer Hist or y  
Ca n cer hist ori es will be s u m marize d as t he n u m bers a n d perce nta ges of s u bjects wit h si g nifica nt me dical -hist or y 
ele m e nts rec or de d o n t he Disease Hist or y C R F f or m. Diseas e Hist or y i nf or mati o n, i ncl u di n g hist ol o g y i nf or mati o n, 
sta ges, disease site a n d pr o gressi ve disease date will be liste d.  
6. 1. 4.  Pri or S ur geries  
Pri or s ur geries  f or t he c urre nt dia g n osis will be s u m marize d i n a ta ble or ga nize d t o dis pla y t he t y pe of s ur ger y, 
dis pla yi n g c o u nts a n d perce nta ges of partici pa nts  w h o re p orte d at least o ne s ur ger y i n eac h gr o u p, b y S O C a n d P T 
acc or di n g t o t he Me d D R A  c urre nt v ersi o n . 
6. 1. 5.  Pri or A nti -c a ncer Tre at me nt s 
Pri or treat me nt f or t he c urre nt ca ncer dia g n osis will be ca pt ure d i n t he e C R F f or m ‘ Pri or Treat me nts f or Disease U n der 
St u d y Dia g n osis ’ a n d will be c o de d usi n g W H O Dr u g Dicti o na r y ( W H O-D D) c urre nt versi o n. A s u m mar y ta ble will 
be or ga nize d t o dis pla y t he t hera p e utic s u b gr o u p a n d preferre d na mes of eac h c o de d me dicati o n. T he s u m mar y ta ble 
will dis pla y c o u nts a n d perce nta ges of partici pa nts  w h o re p orte d usi n g at least o ne me dicati o n i n eac h re prese nte d 
t hera p e utic s u b gr o u p a n d preferre d ter m. All i nf or mati o n rec or de d i n t he C R F, i ncl u di n g start/e n d date, best res p o nse 
f or t hat re gi me, a n d reas o n f or disc o nti n uati o n, will be liste d.  
6. 1. 6.  C o nc o mit a nt Me dic ati o n s 
C o nc o mita nt me dicati o n ( C M) is defi ne d as a n y me dicati o n wit h a start date pri or t o t he date of t he first d ose of st u d y 
treat me nt (bef ore baseli ne) a n d c o nti n ui n g after t he first d ose of st u d y treat me nt or wit h a start date bet wee n t he dates 
of t he first a n d last d ose of st u d y treat me nt.  A n y me dicati o n wit h a start date after t he date of t he last d ose of st u d y 
treat me nt will n ot be c o nsi dere d a C M . A n y me dicati o n wit h a st o p date pri or t o t he first d ose of st u d y treat me nt 
( baseli ne) is defi ne d as a pri or t reat me nt. 
 
C M  will be c o de d usi n g t he W H O -D D c urre nt versi o n a n d will be s u m marize d b y t he a nat o mical mai n class ( 1 st le vel) 
of eac h c o de d me dicati o n a n d, wit hi n t hat, p har mac ol o gical s u b gr o u p ( 3 r d le vel) of t he c o de d me dicati o n. Partici pa nts  
are c o u nte d o nl y o nce i n eac h t hera p e utic class cate g or y. C o nc o mita nt me dicati o n will be s u m marize d usi n g t he S A S  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 0  of 4 6  
 
a n d be ta b ulate d f or eac h d ose le vel usi n g fre q ue ncies a n d perce nta ges. Perce nta ges will be base d  o n t he n u m ber of 
partici pa nt s i n eac h d ose le vel. A listi n g will be pr o d uce d dis pla y i n g t he C M i n dicati o n, d ose, u nits, fre q ue nc y, r o ute, 
start/e n d date of t he me dicati o n. 
6. 1. 7.  C o nc o mit a nt Pr oce d ures  
C o nc o mita nt pr oce d ure is defi ne d as a n y pr oce d ure wit h a sta rt date pri or t o t he date of t he first d ose of st u d y treat me nt 
( bef ore baseli ne) a n d c o nti n ui n g after t he first d ose of st u d y treat me nt or wit h a start date bet wee n t he dates of t he 
first a n d last d ose of st u d y treat me nt. A n y pr oce d ure wit h a start date af ter t he date of t he last d ose of st u d y treat me nt 
will n ot be c o nsi dere d a c o nc o mita nt pr oce d ure. A n y pr oce d ure wit h a st o p date pri or t o t he first d ose of st u d y 
treat me nt is defi ne d as a pri or pr oce d ure. 
 
C o nc o mita nt pr oce d ure will be c o de d usi n g t he Me d D R A c urre nt versi o n. S O C a n d P T will be s u m marize d b y n u m ber 
a n d perce nta ge of partici pa nt s ha vi n g at least o ne occ urre nce of a c o nc o mita nt pr oce d ure. A listi n g will be pr o vi de d 
t o dis pla y t he pr oce d ure reas o n, l ocati o n, a n d date. 
6. 2.  Dis p ositi o n  
C o u nts a n d perc e nta ges will be calc ulate d usi n g t he n u m ber of partici pa nt s i n S A S i n t he rele v a nt c o h ort as t he 
de n o mi nat or. Scree n fail ure is defi ne d as a partici pa nt  w h o si g ns i nf or me d c o nse nt b ut d oes n ot q ualif y f or e nr oll me nt 
i nt o t he st u d y. Scree n fail ures a n d reaso ns will be re p orte d o n scree n l o g a n d be s u m marize d f or all partici pa nt s w h o 
si g n i nf or me d c o nse nt.  
 
F or S A S , a s u m mar y of s u bjects will dis pla y t he n u m bers a n d perce nta ges of partici pa nt s i n eac h d ose le vel b y p hase , 
t otal f or escalati o n  gr o u p , t otal f or e x pa nsi o n gr o u p, a n d t otal f or patie nts fr o m escalati o n  a n d e x pa nsi o n gr o u ps treate d 
at t he d ose use d i n e x pa nsi o n .  
 
E n d of Treat me nt ( E O T) f or m will rec or d t he s u bject’s stat us (c o m plete d or disc o nti n ue d treat me nt), as well as t he 
reas o n f or disc o nti n uati o n of eac h st u d y dr u g ( P L D a n d P F-0 7 9 0 1 8 0 1  are o n se parate d f or ms) base d o n S A S .  
 
E n d of St u d y ( E O S) f or m will rec or d partici pa nt s w h o per ma ne ntl y disc o nti n ue d  t he st u d y, as well as t he reas o ns, 
base d o n S A S .  
6. 3.  Pr ot oc ol De vi ati o ns  
A listi n g will i de ntif y s u bjects w h o were e nr olle d e ve n t h o u g h t he y di d n ot meet o ne or m ore eli gi bilit y criteria, or 
a n y ot her sit uati o ns t hat were n ot c o m plia nt wit h t he pr ot oc ol. T his data will be classifie d as maj or or mi n or 
de viati o n b y t he cli nical tea m, t hat will re vie w peri o dicall y t he pr ot oc ol de viati o ns a n d fi nalize t he de viati o ns pri or 
t o t he data b ase l oc k a n d efficac y a n al yses. 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 1  of 4 6  
 
7.  E F FI C A C Y A N A L Y S E S  
Efficac y a n al yses will use data fr o m t he S A S (f or all efficac y e n d p oi nts). F or re p orti n g res p o nse rate pri or t o st u d y 
c o m pleti o n, t he a n al ysis p o p ulati o n will i ncl u de all patie nts wit h a baseli ne disease assess me nt, a f oll o w -u p 
assess me nt at least 4  wee ks after t he first d ose a n d partici pa nts w h o ha ve disc o nti n ue d t he st u d y f or a n y reas o n.  
Efficac y a n al yses will be desc ri pti ve i n nat ure. S u m mar y ta bles a n d fi g ures will be prese nte d b y d ose c o h orts wit hi n 
t he d ose escalati o n a n d e x pa nsi o n p hases, a n d c o m bi ne d, as a p plica ble. 
7. 1.  Effic ac y O utc o mes  
F or t he efficac y e n d p oi nt, t he cli nical a nti-t u m or efficac y of P F -0 7 9 0 1 8 0 1  i n c om bi nati o n wit h P L D will be e val uate d 
b y t u m or res p o nse as assesse d b y t he i n vesti gat ors usi n g R E CI S T v 1. 1, acc or di n g t o pr ot oc ol a p pe n di x B ( Eise n ha u er, 
2 0 0 9).  
 
T he res p o nse cate g ories of tar get lesi o ns a n d its defi niti o ns are descri be d bel o w:  
C o m plete Res p o nse 
( C R) 
Disa p peara n ce of all tar get lesi o ns. A n y pat h ol o gical l y m p h n o des ( w het her tar get or 
n o n -tar get) m ust ha ve re d ucti o n i n s h ort a xis t o < 1 0 m m.  
P arti al Res p o nse ( P R)  
At least a 3 0 % decrease i n t he s u m of t he l o n gest dia meter ( L D) of tar get lesi o ns, 
ta ki n g as refere nce t he baseli ne s u m L D.  
St a ble Dise ase ( S D)  
Neit her s ufficie nt s hri n ka ge t o q ualif y f or partial res p o nse n or s ufficie nt i ncrease t o 
q ualif y f or P D, ta ki n g  as refere nce t he s mallest s u m L D si nce t he treat me nt starte d.  
Pr o gressi ve Dise ase 
( P D) 
At least a 2 0 % i ncrease i n t he s u m of t he L D of tar get lesi o ns, ta ki n g as refere nce t he 
s mallest s u m o n st u d y (t his i ncl u des t he baseli ne s u m if t hat is t he s mallest o n st u d y). 
I n a d diti o n t o t he relati ve i ncrease of 2 0 %, t he s u m m ust als o de m o nstrate a n abs ol ute 
i ncrease of at least 5 m m. T he a p peara nce of o ne or m ore ne w lesi o ns is als o 
c o nsi dere d P D.  
N ot E v al u a ble ( N E)  
N o i ma gi n g/ meas ure me nt is d o ne at all at a partic ular ti me p oi nt. If o nl y a s u bset of 
lesi o n meas ure me nts is ma de at a n assess me nt, us uall y t he case is als o c o nsi dere d N E 
at t hat ti me p oi nt, u nless a c o n vi nci n g ar g u me nt ca n be ma de t hat t he c o ntri b uti o n of 
t he i n di vi d ual missi n g lesi o n(s) w o ul d n ot c ha n ge t he assi g ne d ti me p oi nt res p o nse, 
w hic h is m ost li kel y t o occ ur i n t he case of P D.  
 
T he res p o nse cate g ories of n o n -tar get lesi o ns a n d its defi niti o ns are descri be d bel o w: 
C o m plete Res p o nse ( C R)  
Disa p peara n ce of all n o n -tar get lesi o ns a n d n or malizati o n of t u m or mar ker le vel.  
St a ble Dise ase/  
I nc o m plete Res p o nse  
(N o n -C R/ N o n -P D)  
Persiste nce of o ne or m ore n o n -tar get lesi o n(s) or/a n d mai nte na nce of t u m or mar ker 
le vel a b o ve t he n or mal li mits.  
Pr o gressi ve Dise ase ( P D)  
A p peara n ce of o ne or m ore ne w lesi o ns a n d/ or u ne q ui v ocal pr o gressi o n of e xisti n g 
n o n -tar get lesi o ns.  
 
T he t u m or res p o nses are re q uire d t o be c o nfir me d b y ra di o gra p hic t u m or assess me nts. If a n i nitial C R or P R is n ote d, 
c o nfir mat or y sca ns m ust be perf or me d at least 4 wee ks later. I n t he case of S D, f oll o w -u p meas ure me nts m ust ha ve 
met t he S D criteria at least o nce after st u d y e ntr y at a mi ni m u m i nter val of n o less t ha n 4 wee ks.  
 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 2  of 4 6  
 
T he ta ble bel o w s u m marizes h o w t he o verall res p o nse will be calc ulate d  at eac h ti me p oi nt base d o n tar get a n d n o n -
tar get lesi o n assess me nt: 
 
T ar g et Lesi o ns  
N o n -t ar get Lesi o ns 
Ne w Lesi o ns  
O ver all Res p o nse  
C R  
C R  
N o  
C R  
C R  
N o n -C R/ n o n -P D  
N o  
P R  
C R  
N ot E val uate d  
N o  
P R  
P R  
N o n -P D or n ot e val uate d  
N o  
P R  
S D  
N o n -P D or n ot e val uate d 
N o  
S D  
N ot E val uate d  
N o n -P D  
N o  
N E  
P D  
A n y  
Yes or N o  
P D  
A n y  
P D  
Yes or N o  
P D  
A n y  
A n y  
Yes  
P D  
 
O bjective Res p o nse R ate ( O R R)  is defi ne d as t he perce nta ge of partici pa nt s i n t he treat me nt gr o u p w h o ha v e a 
c o nfir me d C R or P R t o t he treat me nt wit hi n t he st u d y peri o d. T he O R R will be s u m marize d ta ki n g all tar get lesi o n, 
n o n -tar get lesi o n, a n d ne w lesi o n, i nt o c o nsi derati o n. 
 
T he ta ble bel o w s u m marizes t he o verall res p o nse al g orit h m base d o n n o n -tar get lesi o n assess me nt o nl y: 
 
N o n -t ar g et 
Lesi o ns  
Ne w Lesi o ns  
O ver all Res p o nse  
C R  
N o  
C R a 
N o n -C R/ n o n -P D  
N o  
N o n -C R/ n o n -P D  
N ot all e val uate d  
N o  
N E  
U ne q ui v ocal P D  
A n y  
P D  
A n y  
Yes  
P D  
a Best Res p o nse f or t his c ate g ory als o re q uires n or m aliz ati o n of t u m or m arkers, t u m or n o des < 1 0 m m.  
 
Best Over all Res p o nse ( B O R)  is defi ne d as t he best res p o nse rec or de d ( C R, P R, S D, P D, N E per R E CI S T) fr o m t he 
start of t he treat me nt u ntil disease pr o gressi o n, rec urre nce, start of ne w a nti-ca ncer t hera p y or deat h, w hic he v er is 
earlier, ta ki n g as refere nce f or P D t he s mallest meas ure me nts rec or de d si nce t he treat me nt starte d. T he partici pa nt ’s 
best res p o nse assi g n me nt will de p e n d o n t he ac hie ve me nt of b ot h m eas ure me nt a n d c o nfir mati o n criteria.  T he 
e v al uati o n of B O R will be deter mi ne d acc or di n g t o t he ta ble bel o w w he n c o nfir mati o n of C R a n d P R is re q uire d:  
 
O ver all Res p o nse  ( O R) 
Best O ver all Res p o nse  ( B O R) 
First Ti m e p oi nt  
S u bse q ue nt Ti m e p oi nt  
C R  
C R  
C R  
C R  
P R  
S D, P D or P R a 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 3  of 4 6  
 
C R  
S D  
S D pr o vi de d mi ni m u m criteria f or 
S D d urati o n met  (≥4  wee ks) , 
ot her wise, P D  
C R  
P D  
S D pr o vi de d mi ni m u m criteria f or 
S D d urati o n met  (≥4  wee ks) , 
ot her wise, P D  
C R  
N E  
S D pr o vi de d mi ni m u m criteria f or 
S D d urati o n met  (≥4  wee ks) , 
ot her wise, N E  
P R  
C R  
P R  
P R  
P R  
P R  
P R  
S D  
S D  
P R  
P D  
S D pr o vi de d mi ni m u m criteria f or 
S D d urati o n met  (≥4  wee ks) , 
ot her wise, P D  
P R  
N E  
S D pr o vi de d mi ni m u m criteria f or 
S D d urati o n met  (≥4  wee ks) , 
ot her wise, N E  
N E  
N E  
N E  
a If a C R is tr uly met at first ti me p oi nt, t h e n a ny dise ase see n at a s u bse q ue nt ti me p oi nt, eve n dise ase meeti n g P R criteri a rel ative 
t o b aseli ne, m akes t his dise ase P D at t h at p oi nt (si nce dise ase m ust h ave re a p pe are d after C R). Best res p o nse w o ul d de pe n d o n 
w het h er mi ni m u m d ur ati o n f or S D w as met. H o wever s o meti mes ‘ C R’ m ay be cl ai me d w he n s u bse q ue nt sc a ns s u g gest s m all lesi o ns 
were likely still prese nt a n d i n f a ct t h e p artici p a nt  h a d P R, n ot C R at t he first ti me p oi nt. U n der t h ese circ u mst a nces, t h e ori gi n al 
C R s h o ul d be c h a n ge d t o P R a n d t h e best res p o nse is P R.   
 
F or partici pa nt s wit h as y m pt o matic pr o gressi o n a n d i n t he a bse nce of u nacce pta ble t o xicit y, t he partici pa nt  s h o ul d 
c o nti n ue treat me nt a n d a c o nfir mati o n sca n s h o ul d be c o n d ucte d at least f o ur we e ks later t o d oc u me nt o bjecti ve 
pr o gressi o n pri or t o re m o vi n g  t he partici pa nt  fr o m st u d y treat me nt. 
7. 1. 1.  Pri m ar y Effic ac y O utc o me A n al ysis  
O bjective Res p o nse R ate  ( O R R), defi ne d as t he pr o p orti o n of partici pa nt s’ best o verall res p o nse ac hie vi n g a c o nfir me d 
C R o r P R, per i n vesti gat or, at a n y ti me o n t he st u d y, will be s u m marize d descri pti vel y b y d ose c o h ort wit hi n t he d ose 
escalati o n a n d e x pa nsi o n p hases. Baseli ne d oc u me ntati o n of “tar get” a n d “ n o n -tar get” lesi o ns (lesi o n c o u nt a n d 
ma xi m u m lesi o n le n gt h) will be rec or de d i n listi n gs. T he s u m of dia meters will be calc ulate d f or all tar get lesi o ns at 
baseli ne a n d at eac h s u bse q ue nt t u m or assess me nt as a meas ure of t u m or b ur de n. T he baseli ne lesi o n size or t he 
s mallest meas ure me nt o n st u d y val ue will be use d as refere nce b y w hic h t o c haracterize t he lesi o n res p o nse. 
 
Per R E CI S T criteria, tar get lesi o ns c o nsi dere d ‘t o o s mall t o meas ure’ will be assi g ne d a defa ult val ue of 5 m m a n d 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 4  of 4 6  
 
t h ose i de ntifie d as ‘ n ot prese nt’ will be assi g ne d 0 m m f or p ur p oses of a nal ysis.  
 
F or efficac y res p o nse para meters, a 9 5 % c o nfi de nce i nter val ( CI) usi n g Wils o n’s sc ore met h o d will be prese nte d f or 
t he p hase 2 e x pa nsi o n c o h ort s, or c o m bi ne d data fr o m p hase 1 a n d p hase 2 at t he c o m m o n d ose use d i n t he e x pa nsi o n 
c o h ort . All S A S partici pa nt s will be i ncl u de d i n t he de n o mi nat ors f or perce nta ge, e ve n if t he partici pa nt  ha d a N E 
res p o nse. T he O bjecti ve Res p o nse Rate a n d B O R ( C R, P R, S D, P D, N E) will be s u m marize d descri pti vel y f or 
R E CI S T assess me nt met h o d, f or b ot h p hase 1  d ose escalati o n a n d p hase 2 e x pa nsi o n c o h orts , a n d c o m bi ne d f or t he 
c o m m o n d ose .  
 
Si milarl y, t he pr o p orti o n of partici pa nt s wit h a B O R  as C R a n d t he pr o p orti o n of partici pa nt s wit h a B O R  as P R at 
a n y ti me d uri n g t he st u d y will be s u m marize d as part of t he B O R.  
 
 O verall t u m or  res p o nse assess me nt d ata will be prese nte d i n listi n gs. 
7. 1. 2.  Sec o n d ar y Effic ac y O utc o me A n al ysis  
D ur ati o n of res p o nse ( D O R)  will be calc ulate d f or partici pa nt s w h o ac hie ve a c o nfir me d C R or c o nfir me d P R, a n d is 
defi ne d as t he ti me fr o m t he date of first d oc u me nte d res p o nse ( C R or P R) t o t he date of d oc u me nte d pr o gressi o n or 
deat h of a n y ca use after ac hie vi n g res p o nse. Partici pa nt s w h o c o m plete or disc o nti n ue t he st u d y wit h o ut disease 
pr o gressi o n or deat h, as well as partici pa nt s w h o recei ve alter nate a nti-ca nce r t hera p y pri or t o disease pr o gressi o n, 
will be ce ns ore d at t heir last a d e q uate  res p o nse assess me nt date or last a de q uate  assess me nt pri or t o t he start date of 
alter nate a nti -ca ncer t hera p y. T he n u m ber of e ve nts a n d t he n u m ber of ce ns ore d partici pa nt s will be s u m marize d, a n d 
t he me dia n ti me t o P D or deat h e v e nt (re p orte d i n da ys), its 9 5 % c o nfi de nce i nter val ( usi n g Br o o k me yer-Cr o wle y 
met h o d) , a n d t he 2 5t h a n d 7 5t h perce ntiles o n t he ti me t o e ve nt f or c o h ort will be s u m marize d.  
 
Dise ase C o ntr ol R ate ( D C R)  is defi ne d as t he perce nta ge of partici pa nt s w h o ha ve ac hie ve d C R, P R, or S D lasti n g at 
least 1 2 wee ks. D C R at a n y ti me d uri n g t he st u d y will be s u m marize d, as per t he R E CI S T assess me nt met h o d.  
 
Pr o gressi o n Free S urviv al ( P F S)  is defi ne d as t he ti me fr o m t he first P F-0 7 9 0 1 8 0 1 i njecti o n ( C ycle 1 Da y 1) t o P D 
or deat h of a n y ca use, w hic he v er is first. Partici pa nt s w h o c o m plete or disc o nti n ue t he st u d y wit h o ut disease 
pr o gressi o n or deat h, as well as partici pa nt s w h o recei ve alter nate a nti-ca ncer t hera p y pri or t o disease pr o gressi o n, 
will be ce ns ore d at t heir last a d e q uate  res p o nse assess me nt date or last a de q uate  assess me nt pri or t o t he start date of 
alter nate a nti -ca ncer t hera p y. If date of pr o gressi o n occ urs o n t he sa me date as t he start of ne w a ntica ncer t hera p y, t he 
pr o gressi o n will be c o u nte d as a n e v e nt . If t here is P D or deat h after missi n g 2 pla n ne d assess me nts, t he partici pa nt  
will be ce ns ore d at t he last n o n -P D assess me nt. Ce ns ori n g reas o ns will be s u m marize d i n t he P F S o ut p ut.  
 
F or partici pa nts w h o d o n ot ha v e a n a d e q uate baseli ne t u m or asse ss me nt or w h o d o n ot ha ve a n y p ost baseli ne t u m or 
assess me nts, ce ns ori n g will occ ur o n t he date of first d ose u nless deat h occ urre d o n or bef ore t he ti me of t he sec o n d 
pla n ne d t u m or assess me nt  i n w hic h case t he deat h will be c o nsi dere d a n e ve nt.  N ote f or partici pa nts w h o die d wit h o ut 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 5  of 4 6  
 
a n y p ost baseli ne assess me nts a n d meet t he defi niti o n of 2 or m ore missi n g assess me nt , t he reas o n f or ce ns ori n g will 
be d oc u me nte d as 2 or m ore misse d assess me nts a n d ce ns ori n g will occ ur o n t he date of first d ose.  
 
T he n u m ber of e v e nts a n d t he n u m ber of ce ns ore d partici pa nt s will be s u m marize d. P F S rat e at selecte d ti mes, as well 
as t he me dia n ti me t o e v e nt (re p orte d i n da ys), its 9 5 % c o nfi de nce i nter val  ( usi n g Br o o k me yer-Cr o wle y met h o d) , a n d 
t he 2 5t h a n d 7 5t h perce ntiles o n t he ti me t o e ve nt f or c o h ort will be s u m marize d. Ka pla n -Meier pl ot of P F S will als o 
be pr o vi de d.  
 
Over all S urviv al ( O S)  is defi ne d as t he ti me fr o m t he first P F-0 7 9 0 1 8 0 1 i njecti o n ( C ycle 1 Da y 1) t o deat h of a n y 
ca use. Partici pa nt s wit h o ut d eat h date  at t he ti me of a nal ysis will be ce ns ore d at t heir last k n o w n ali ve date. Ka pla n -
Meier met h o d ol o g y si milar t o t he P F S a nal ysis will be use d t o s u m marize t he res ults.  
 
Waterfall pl ot f or tar get lesi o n t u m or res p o nse b y i n di vi d ual will be prese nte d , i n dicati n g best t u m or res p o nse 
( ma xi m u m re d ucti o n of  t he su m of l o n gest dia meters  fr o m baseli ne) at a n y ti me p oi nt f or eac h s u bject. T he pl ot will 
ha v e o ne bar per s u bject s orte d fr o m w orst t o best res p o nse wit h c ol or b y d ose a d mi nistere d.  T u m or res p o ns e will be 
calc ulate d base d o n t he t y pe of ca ncer t hat t he partici pa nt  has, wit h t he a p pr o priate meas ure usi n g R E CI S T.  
 
S pa g hetti pl ots f or tar get lesi o n t u m or res p o nse b y ti me will be prese nte d f or all partici pa nt s at all visits, b y d ose. O ne 
li ne will be dra w n per s u bject wit h c ol or b y res p o nse t y pe. T he h oriz o ntal a xis will be t he ti me a n d t he vertical a xis 
will be t he perce nt c h a n ge fr o m baseli ne i n t u m or res p o nse. O ne set of s pa g hetti pl ots will be ge nerate d f or R E CI S T 
assess me nt a n d o nl y partici pa nt s w it h n o n -missi n g  t u m or assess me nt s will be s h o w n.  
 
S wi m mer pl ots f or t u m or res p o nse will be ge n erate d wit h R E CI S T assess me nt. T he pl ots will ha ve o ne h oriz o ntal bar 
per s u bject firstl y s orte d b y Best Res p o nse, a n d t he n s orte d fr o m earliest t o latest ti me t o  start of res p o nse f or C R a n d 
P R; wit hi n cate g ories of S D, P D a n d N E, partici pa nt s will be s orte d b y ma xi m u m o bser vati o n d urati o n. S y m b ols 
wit hi n t he s wi m mer pl ot will i n dicate ti me t o start a n d e n d of eac h ne w le vel of res p o nse (if t he e n d of o ne res p o nse  
is t he start of a ne w t y pe of res p o nse b y defi niti o n, o nl y t he start will be s h o w n). T he pl ots will als o s h o w t he le n gt h 
of treat me nt d urati o n a partici pa nt  ha d.  
 
8.  S A F E T Y A N A L Y S E S  
S u m mar y of A Es a n d ot her safet y para meters will be base d o n t he safet y a nal y sis set (S A S) b y p hase a n d d ose 
c o h ort, e xce pt f or t he D L T, w hic h will be base d o n D L T -E val ua ble P o p ulati o n ( D L P) b y d ose c o h ort.  
8. 1.  E x p os ure  
O n Da y 1 of eac h c y cle, P L D will prece d e a d mi nistrati o n of P F -0 7 9 0 1 8 0 1. A n o bser vati o n peri o d bet wee n c o m pleti o n 
of P L D i nf usi o n a n d i nitiati o n of P F -0 7 9 0 1 8 0 1 i nf usi o n is n ot ma n date d. C o h orts/ d ose le vels f or p hase 1 escalati o n 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 6  of 4 6  
 
part of t he st u d y wit h t he intra ve n o us e x p os ure t o st u d y dr u gs P L D a n d P F -0 7 9 0 1 8 0 1 (after P L D) a n d its sc he d ule of 
a d mi nistrati o n per 2 8 -da y c ycle is s u m marize d bel o w:  
C o h ort /  
D ose Le v el  ( D L) 
P L D D ose [ m g/ m
2] 
Sc h e d ule of a d mi nistr ati o n  
P F -0 7 9 0 1 8 0 1  D ose [ m g/ k g]  
Sc he d ule of a d mi nistr ati o n  
1  
4 0  
D a y 1  of every 2 8 d ay -cycle 
1 2  
Cycle 1: D ay 1, D ay 8, D ay 1 5, a n d D ay 2 2  
Cycle 2 a n d a b ove: D ay 1 a n d D ay 1 5  
2  
4 0  
D ay 1  of every 2 8 d ay -cycle 
2 4  
Cycle 1: D ay 1, D ay 8, D ay 1 5, a n d D ay 2 2  
Cycle 2 a n d a b ove: D ay 1 a n d D ay 1 5  
3  
4 0  
D ay 1  of every 2 8 d ay -cycle 
4 8  
A ny cycle : D ay 1 a n d D ay 1 5 a 
 
T he f oll o wi n g r ules a p pl y d uri n g d ose escalati o n:  
•  
Starti n g d ose at  d ose le vel 1 is 1 2 m g/ k g.  
•  
At least 3 partici pa nts will be e nr olle d at eac h d ose le vel. W he n all partici pa nts at a d ose le vel 
c o m plete D L T assess me nts, t he st u d y will escalate t o t he ne xt d ose le vel a n d a n ot her 3 partici pa nts 
will be recr uite d i n t his or der u ntil M T D/ R P 2 D.  
•  
If a gree d u p o n b y t he i n vesti gat ors a n d Pfizer (e g , base d o n safet y, i nci de nce of D LT , P K a n d d ose-
e x p os ure data fr o m pri or a n d c urre nt c o h orts) t hat i ncreasi n g t he d ose f urt her ma y n ot yiel d 
a d diti o nal be n efit, t he d ose ma y sta y at t he c urre nt d ose le vel, be de -escalate d t o a n y d ose, or n o 
f ut ure escalati o n ma y be ma de, e ve n if t he d ose escalati o n r ule i ndicates t o escalate.  
•  
T he nee d f or d ose escalati o n t o a s pecific d ose be y o n d 4 8 m g/ k g or de -escalati o n t o a n i nter me diate 
d ose le vel will be e v al uate d j oi ntl y b y i n vesti gat ors a n d Pfizer base d o n c u m ulati ve cli nical safet y, 
P K, a n d preli mi nar y efficac y data . 
 
A partici pa nt w h o c o m pletes at least f o ur c y cles of treat me nt wit h P F -0 7 9 0 1 8 0 1 i n c o m bi nati o n wit h P L D a n d re q uires 
disc o nti n uati o n of P L D d ue t o P L D -relate d t o xicit y a n d w h o is recei vi n g disease c o ntr ol ma y c o nti n ue o n st u d y 
recei vi n g P F-0 7 9 0 1 8 0 1 m o n ot hera p y be gi n ni n g wit h t he ne xt c ycle pr o vi de d t he partici pa nt has n ot e x perie nce d 
disease pr o gressi o n a n d P F -0 7 9 0 1 8 0 1 re -treat me nt g ui deli nes as descri be d i n Secti o n 9. 1. 2 of t he pr ot oc ol are met.  
 
E x p os ure t o P F -0 7 9 0 1 8 0 1 a n d P L D will be s u m marize d wit h d escri pti ve statistics f or t he n u m ber of n o n -zer o d oses 
recei ve d, d urati o n of d osi n g ( wee ks), t otal c u m ulati ve d ose ( m g/ k g f or P F-0 7 9 0 1 8 0 1, m g/ m 2 f or P L D), a n d o verall 
relati ve i nte nsit y.  
 
D urati o n of treat me nt is defi ne d as t he ti me (i n wee ks) fr o m first d ose of st u d y dr u g i n c ycle 1 t o t he last d ose of st u d y 
dr u g i n t he last c y cle a partici pa nt  ha d.  
 
T otal c u m ulati ve d ose is t he s u m of t he act ual d oses of P F -0 7 9 0 1 8 0 1 or P L D recei ve d.  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 7  of 4 6  
 
 
T he calc ulati o n al g orit h m f or d urati o n of e x p os ure (i n wee ks ) f or eac h dr u g a n d i nte n de d d urati o n of P F -0 7 9 0 1 8 0 1 
treat me nt will be : 
 
•  
D urati o n of P L D  e x p os ure ( wee ks) = ( Last P L D d ose date –  first P L D d ose date + 2 8 ) / 7 
 
•  
D urati o n of P F -0 7 9 0 1 8 0 1  e x p os ure ( wee ks)  
o  
D L 1 a n d D L 2 → If t he last d ose occ urs d uri n g  cycle  1: ( Last P F -0 7 9 0 1 8 0 1  d ose date –  
first P F-0 7 9 0 1 8 0 1  d ose date + 7)  / 7 
o  
D L 1 a n d D L 2 → If t he last d ose occ urs d uri n g c ycle 2  a n d be y o n d : ( Last P F-0 7 9 0 1 8 0 1  
d ose date –  first P F-0 7 9 0 1 8 0 1  d ose date + 1 4)  / 7 
o  
D L 3: ( Last P F -0 7 9 0 1 8 0 1 d ose date –  first P F-0 7 9 0 1 8 0 1 d ose date  + 1 4)  / 7 
 
O verall relati ve i nte nsit y (i n %) f or eac h dr u g is calc ulate d as 1 0 0 × c u m ulati ve d ose recei ve d di vi de d b y c u m ulati ve 
d ose pla n ne d, w here:  
•  
C u m ulati ve d ose of P L D pla n ne d ( m g/ m 2) = Pla n ne d P L D d ose/c y cle  ( 4 0) × D urati o n of P L D 
e x p os ure ( wee ks)   
 
•  
C u m ulati ve d ose of P L D recei ve d ( m g/ m 2) = S u m of all P L D d oses ( m g/ m2) act uall y recei ve d.  
 
•  
Relati ve D ose I nte nsit y ( %) of P L D = C u m ulati ve d ose of P L D pla n ne d ( m g/ m 2) / C u m ulati ve d ose 
of P L D recei ve d ( m g/ m 2) × 1 0 0 % 
 
•  
C u m ulati ve d ose of P F -0 7 9 0 1 8 0 1 pla n ne d ( m g/ k g) , w here D =  pla n ne d d ose f or t he partici pa nt s 
acc or di n g t o t he D L ( 1 2, 2 4 or 4 8 m g/ k g)  a n d C = n u m ber of treat me nt c ycles:  
o  
D L 1 a n d D L 2: ( pla n ne d P F -0 7 9 0 1 8 0 1 d ose/c y cle × c ycle 1 × n u m ber of  pla n ne d  
a d mi nistrati o ns of P F -0 7 9 0 1 8 0 1 i n c ycle 1) + ( pla n ne d P F -0 7 9 0 1 8 0 1 d ose/c y cle × n u m ber 
of c y cles of P F -0 7 9 0 1 8 0 1 after c ycle 1 × n u m ber of pla n ne d a d mi nistrati o ns of P F -
0 7 9 0 1 8 0 1 per c y cle) = ( D × 1 × 4) + ( D × [ C-1] × 2)  
o  
D L 3: pla n ne d d ose/c y cle × n u m ber of c ycles of P F -0 7 9 0 1 8 0 1 × n u m ber of pla n ne d 
a d mi nistrati o ns of P F -0 7 9 0 1 8 0 1 per c ycle = 4 8 × C × 2  
 
•  
C u m ulati ve d ose of P F -0 7 9 0 1 8 0 1 recei ve d ( m g/ k g) = S u m of all P F -0 7 9 0 1 8 0 1 d oses ( m g/ k g) 
act uall y recei ve d.  
 
•  
Relati ve D ose I nte nsit y ( %) of P F -0 7 9 0 1 8 0 1 = C u m ula ti ve d ose of P F-0 7 9 0 1 8 0 1 pla n ne d ( m g/ m 2) 
/ C u m ulati ve d ose of P L D recei ve d ( m g/ m2) × 1 0 0 % 
 
T he n u m ber of dr u g a d mi nistrati o ns wit h d ose re d ucti o n, i nf usi o n hel d or per ma ne ntl y wit h dra w n will als o be 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 8  of 4 6  
 
s u m marize d descri pti vel y b y c o h ort, f or eac h st u d y dr u g (P F -0 7 9 0 1 8 0 1 a n d P L D).  
 
I n a d diti o n, t he pla n ne d d osi n g date a n d t he act ual d osi n g date will be liste d. Listi n gs will be pr o vi de d wit h t he 
i nf or mati o n fr o m all t he st u d y dr u g a d mi nistrati o n e C R Fs.  Reas o ns f or misse d d oses of P F-0 7 9 0 1 8 0 1  a n d P L D  will 
be lis te d. 
8. 2.  Tre at me nt C o m pli a nce  
8. 2. 1.  D ose Del a ys  
D ose dela y is t he differe n ce bet wee n t he act ual ti me bet wee n t w o c o nsec uti ve n o n -zer o d oses a n d t he pla n ne d ti me 
bet wee n t he sa me t w o c o nsec uti ve n o n -zer o d oses.  
D ose d ela y f or d ose x ( da ys) = Date of d ose x –  Date of d ose ( x -1) –  Pla n ne d da ys bet wee n t w o  c o nsec uti ve 
d oses.  
D ose dela ys will be gr o u pe d i nt o t he f oll o wi n g cate g ories:  
•  
N o dela y  
o  
0 da ys dela y  
o  
1 -3 da ys dela y  
•  
4 -6 da ys dela y  
•  
7 or m ore da ys dela y  
F or e x a m ple, f or P F -0 7 9 0 1 8 0 1, i nitiall y a d mi nistere d o n a wee kl y sc he d ule, if o ne partici pa nt recei v es P F-0 7 9 0 1 8 0 1 
o n Da y 1, t he n t he ne xt P F -0 7 9 0 1 8 0 1 a d mi nistrati o n date will be o n Da y 8; h o we v er, if t he partici pa nt recei ves P F -
0 7 9 0 1 8 0 1 at Da y 9 or 1 0, t his is c o nsi dere d as 1 -3 da ys dela y.   
T he n u m ber a n d perce nta ge of partici pa nts wit h dela y e d st u d y d r u g a d mi nistrati o n a n d ma xi m u m le n gt h of dela y, i.e., 
t he w orst case of dela y if partici pa nts ha v e m ulti ple d ose dela ys will be s u m marize d f or t he o verall st u d y. 
8. 2. 2.  D ose Re d ucti o ns  
D ose re d ucti o n is defi ne d as act ual n o n -zer o d ose < 9 0 % of t he pla n ne d d ose. T he n u m ber a n d perce nta ge of 
partici pa nts wit h at least o ne d ose re d ucti o n as well as a brea k d o w n of t he n u m ber of d ose re d ucti o ns ( 1, 2, 3, ≥4) will 
be s u m marize d.  
8. 2. 3.  I nf usi o n I nterr u pti o ns 
A n i nf usi o n i nterr u pti o n is defi ne d as a n i nf usi o n t hat is st o p pe d a n d re -starte d o n t he sa me da y (i.e., f or a visit m ore 
t ha n o ne i nf usi o n start ti me a n d i nf usi o n e n d ti me are rec or de d). 
 
T he n u m ber a n d perce nta ge of partici pa nts wit h at least o ne i nf usi o n i nterr u pti o n as well as t he fre q ue n c y of 
partici pa nts wit h 1 , 2, 3, or ≥4 i nf usi o n i nterr u pti o ns will be s u m marize d. 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 2 9  of 4 6  
 
8. 3.  D ose -li miti n g t o xicit y 
D ose -li miti n g t o xicit y ( D L T) is defi ne d as 
 a n d/ or 
 treat me nt-e mer ge nt a d verse e v e nt  
t hat occ urs d uri n g t he 2 8-da y C ycle 1 a n d are j u d ge d b y t he i n ves ti gat or as relate d t o P F-0 7 9 0 1 8 0 1 or t he c o m bi nati o n 
of P F -0 7 9 0 1 8 0 1 a n d P L D. A d verse e v e nts t hat are i n t he o pi ni o n of t he i n vesti gat or attri b uta ble e xcl usi vel y t o 
i ntra v e n o us i nf usi o n of P L D or a n y P L D pr o p h yla xis me dicati o n will n ot be c o nsi dere d a D L T. A Es t o be c o nsi dere d 
as D L T are liste d i n t he st u d y pr ot oc ol.  A patie nt wit h o ut D L T m ust recei ve at least t w o d oses of P F S t o be calle d 
D L T -free. 
 
T hese D L T will be s u m marize d, i ncl u di n g n u m ber a n d perce nta ge of partici pa nt s, i n t he D L T-e val ua ble p o p ulati o n 
( D L P). A partici pa nt w h o wit h dra ws fr o m t he st u d y d uri n g c ycle 1 i n t he a bse nce of D L T -e val ua ble ( i.e., n ot recei vi n g 
P L D a n d at least t w o d oses of P F - 0 7 9 0 1 8 0 1) will be re place d.  
 
A Es a n d Seri o us A Es ( S A E) will be deter mi ne d t o be d ose -li miti n g if t he y occ ur wit h c ycle 1 a n d meet t he descri be d 
criteria  a b o ve . A Es or S A Es e x perie nce d after t he e n d of cycle 1 will n ot be re p orte d as D L Ts b ut  will be  d oc u me nte d.  
8. 4.  A d verse E ve nts  
A d verse e v e nts ( A Es) will be d oc u me nte d o n t he A E e C R F a n d m o nit ore d c o nti n u o usl y t hr o u g h o ut t he st u d y. A d verse 
e v e nts will be c o de d usi n g t he Me dical Dicti o nar y f or Re g ulat or y Acti vities ( Me d D R A), latest versi o n, ass ociati n g 
lo wer -le vel ter ms wit h P T a n d S O C b y t he pri mar y hierarc h y.  
 
Treat me nt -E mer ge nt A d verse E ve nts ( T E A E) are defi ne d as a n y e ve nt t hat occ urs or w orse ns o n or after t he da y st u d y 
treat me nt P F-0 7 9 0 1 8 0 1  is i nitiate d t hr o u g h mi ni m u m ( 3 0 da ys + last d ose of st u d y treat me nt, start da y of ne w a nti-
ca ncer dr u g t hera p y –  1 da y) , defi ne d as o n-treat me nt peri o d. T he ta bles will dis pla y c o u nts a n d perce nta ges of 
partici pa nt s w h o re p orte d at least o ne T E A E i n eac h  S O C r e prese nte d i n t he A E data. Wit hi n eac h S O C, t he ta bles 
will dis pla y t he c o u nts a n d perce nta ges of partici pa nt s re p orti n g at least o ne T E A E, as desi g nate d b y t he P T.   
 
T he se v erit y of a d verse e v e nts will be gra d e d usi n g t he N CI C o m m o n T o xicit y Criter ia f or A d verse E ve nts ( C T C A E 
versi o n 5. 0). T he i nte nsit y is assi g ne d a gra de of 1 t hr o u g h 5 usi n g t he f oll o wi n g C T C A E g ui deli nes: Gra de 1 –  Mil d; 
Gra d e 2 –  M o derate; Gra de 3 –  Se vere; Gra d e 4 –  Life -t hreate ni n g; Gra de 5 –  Deat h.  
 
T he ca usalit y of A E is re porte d as eit her relate d t o st u d y dr u g or n ot relate d t o st u d y dr u g f or eac h st u d y dr u g  (P F -
0 7 9 0 1 8 0 1 a n d P L D) . If t he relati o ns hi p t o a treat me nt is missi n g, it will be c o nsi dere d as “relate d”.  
 
If a partici pa nt  has m ulti ple occ urre n ces of a n a d verse e ve nt , t he str o n gest le vel of relati o ns hi p t o st u d y dr u g a n d t he 
w orst t o xicit y gra d e a partici pa nt  e x perie nces f or a gi ve n A E will be use d i n t hese ta bl es. N o i m p utati o n will be 
perf or me d f or missi n g t o xicit y gra d e.  
 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)
C CI
C CI


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 0  of 4 6  
 
A Es t hat ha v e missi n g o nset dates will be c o nsi dere d as T E A E u nless t he st o p date is k n o w n t o be pri or t o t he first 
a d mi nistrati o n of t he st u d y me dicati o n. If t he A E o nset date is partial, t he date will be c orrelate d as far as p ossi ble 
wit h t he date of first d ose of st u d y me dicati o n. A E will be ass u me d t o be T E A E, u nless t here is clear e vi de nce (t hr o u g h 
c o m paris o n of partial dates) t o s u g gest t hat t he a d verse e ve nt starte d pri or t o t he first d ose of st u d y me dicati o n. 
Detaile d date i m p utati o n r ules ca n be f o u n d i n secti o n 5. 4. 1 . If partici pa nt s die d d uri n g t he st u d y a n d e x perie nce d A Es 
at t he ti me of deat h, t he A Es t hat lea d t o deat h will use deat h date as t he A E e n d date; ot her wise, A Es t hat d o n ot lea d 
t o deat h will be re p orte d as o n g oi n g. 
 
T here are n o A d verse E ve nts of S pecial I nterest ( A E SI)  relate d t o t he st u d y dr u gs i n t his pr ot oc ol. 
 
T he f oll o wi n g T E A E s u m mar y ta bles will b e pr o d uce d b y d ose c o h ort, a n d o verall:  
 
•  
A n o verall s u m mar y of safet y will s u m marize t he n u m bers (a n d perce nta ges) of partici pa nt s wit h 
t he f oll o wi n g: 
o  
T E A Es  
o  
Gra d e ≥ 3 T E A Es  
o  
Relate d T E A Es [relate d t o P F -0 7 9 0 1 8 0 1  o nl y, P L D o nl y, a n y st u d y dr u g, a n d b ot h dr u gs]  
o  
Relate d gra d e ≥ 3 T E A Es [ relate d t o P F-0 7 9 0 1 8 0 1 o nl y, P L D o nl y, a n y st u d y dr u g, a n d 
b ot h dr u gs ] 
o  
Seri o us T E A Es  
o  
Relate d Seri o us T E A Es [ relate d t o P F-0 7 9 0 1 8 0 1 o nl y, P L D o nl y, a n y st u d y dr u g, a n d 
b ot h dr u gs ] 
o  
T E A Es lea di n g t o d ose re d ucti o n ( of P F -0 7 9 0 1 8 0 1  a n d P L D , se paratel y) 
o  
T E A Es lea di n g t o dr u g i nterr u pti o n (of P F -0 7 9 0 1 8 0 1  a n d P L D , se paratel y)  
o  
T E A Es lea di n g t o per ma ne ntl y disc o nti n ue d st u d y dr u g ( P F -0 7 9 0 1 8 0 1, P L D , a ny dr u g, 
a n d b ot h)    
o  
Relate d T E A Es [relate d t o P F -0 7 9 0 1 8 0 1  o nl y] lea di n g t o per ma ne nt disc o nti n uati o n of 
P F -0 7 9 0 1 8 0 1  
o  
Relate d T E A Es (relate d t o P L D  o nl y) lea di n g t o per ma ne nt disc o nti n uati o n of P L D  
o  
Relate d T E A Es (relate d t o b ot h dr u gs) lea di n g t o per ma ne nt disc o nti n uati o n of b ot h dr u gs  
o  
T E A Es lea di n g t o deat h  
o  
Relate d T E A Es [ relate d t o P F-0 7 9 0 1 8 0 1 o nl y, P L D o nl y, a n y st u d y dr u g, a n d b ot h dr u gs ] 
lea di n g t o deat h 
 
•  
Se parate s u m maries of T E A Es b y S O C a n d P T, as f oll o ws:  
o  
All T E A Es (a n y gra de)  
o  
All gra d e ≥ 3 T E A Es  
o  
Relate d T E A Es [ relate d t o P F-0 7 9 0 1 8 0 1 o nl y, P L D o nl y, a n y st u d y dr u g, a n d b ot h dr u gs ] 
(a n y gra d e) 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 1  of 4 6  
 
o  
Relate d T E A Es [ relate d t o P F-0 7 9 0 1 8 0 1 o nl y, P L D o nl y, a n y st u d y dr u g, a n d b ot h dr u gs ] 
( gra d e ≥ 3)  
o  
All Seri o us T E A Es  
o  
Relate d Seri o us T E A Es [ relate d t o P F-0 7 9 0 1 8 0 1 o nl y, P L D o nl y, a n y st u d y dr u g, a n d 
b ot h dr u gs ]  
o  
All T E A Es lea di n g t o d ose re d ucti o n ( of P F -0 7 9 0 1 8 0 1  a n d P L D , se paratel y) 
o  
All T E A Es lea di n g t o dr u g i nterr u pti o n  ( of P F-0 7 9 0 1 8 0 1 a n d P L D, se paratel y)  
o  
Relate d T E A Es [relate d t o P F -0 7 9 0 1 8 0 1  o nl y]  lea di n g t o per ma ne nt disc o nti n uati o n of 
P F -0 7 9 0 1 8 0 1  
o  
Relate d T E A Es (relate d t o P L D  o nl y) lea di n g t o per ma ne nt disc o nti n uati o n of P L D  
o  
Relate d T E A Es (relate d t o b ot h dr u gs) lea di n g t o per ma ne nt disc o nti n uati o n of b ot h dr u gs  
o  
All T E A Es lea di n g t o deat h  
o  
All relate d T E A Es [relate d t o P F-0 7 9 0 1 8 0 1 o nl y, P L D o nl y, a n y st u d y dr u g, a n d b ot h 
dr u gs ] lea di n g t o deat h 
 
•  
S u m mar y of i nf usi o n relate d reacti o ns (a n y gra de a n d Gra de ≥ 3) b y P T  
 
•  
All T E A Es b y S O C, P T, a n d ma xi m u m se verit y ( C T C A E t o xicit y gra de)  
 
•  
D L Ts b y S O C, P T, a n d ma xi m u m se verit y ( C T C A E t o xicit y gra de)  
 
T he f oll o wi n g A E listi n gs will be pr o d uce d, s orte d b y d ose c o h ort, partici pa nt , a n d ti mi n g, wit h rele v a nt i nf or mati o n: 
•  
A ll A Es  
•  
All D L Ts  
•  
A Es lea di n g t o deat h  
8. 5.  De at hs  
T he fre q ue nc y ( n u m ber a n d perce nta ge) of s u bjects i n t he S A S  w h o die d a n d w h o die d wit hi n 3 0 da ys after last d ose 
of st u d y treat me nt as well as t he reas o n f or deat h, will be ta b ulate d:  
•  
All d eat hs  
•  
Deat hs wit hi n 3 0 da ys after last d ose of st u d y treat me nt  
•  
Ca use o f deat h  
 
I n a d diti o n, date a n d ca use of deat h will be pr o vi de d i n i n di vi d ual partici pa nt data listi n g t o get her wit h selecte d d osi n g 
i nf or mati o n (st u d y treat me nt recei ve d, date of first / last a d mi nistrati o n, d ose) a n d will i ncl u de t he f oll o wi n g 
i nf or mati o n: 
•  
A Es wit h fatal o utc o me ( Listi n g of P Ts of A Es wit h o utc o me = Fatal, as well as A Es of Gra d e 5)  
•  
Fla g f or deat h wit hi n 3 0 da ys of last d ose of st u d y treat me nt.  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 2  of 4 6  
 
8. 6.  Cli nic al L a b or at or y Res ults  
Cli nical la b orat or y tests (ser u m c h e mistr y a n d he mat ol o g y) will be perf or me d at scree ni n g a n d, ge nerall y, eac h da y 
recei vi n g a PF -0 7 9 0 1 8 0  d ose, u nless ot her wise s pecifie d i n ta ble 2 8. Sc he d ule of Assess me nt, of t he pr ot oc ol. Baseli ne 
la b orat or y meas ure me nts d o n ot nee d t o be re peate d if scree ni n g meas ure me nts were perf or me d wit hi n 3 da ys pri or 
t o C ycle 1 Da y 1. All la b orat or y data will be c o n verte d t o sta n dar dize d c o n ve nti o nal u nits f or re p orti n g p ur p oses.  
 
Ser u m c h e mistr y  tests i ncl u de deter mi nati o n of t he f oll o wi n g para meters: gl uc ose, s o di u m, p otassi u m, calci u m, 
c hl ori de, p h os p hate, bicar b o nate, b l o o d urea nitr o ge n or urea, creati ni ne, t otal pr otei n, al b u mi n, al kali ne p h os p hatase, 
as partate a mi n otra nsferase ( A S T), ala ni ne a mi n otra nsferase ( A L T), t otal bilir u bi n, i n direct bilir u bi n, uric aci d, 
calci u m, ma g nesi u m, a n d lactate de h y dr o ge nase ( L D H).  
 
He mat ol o g y tests i ncl u de  deter mi nati o n of t he f oll o wi n g para meters: He m o gl o bi n, he mat ocrit, platelets, w hite bl o o d 
cells ( W B C), ne utr o p hils, l y m p h oc ytes, e osi n o p hils, bas o p hils, m o n oc ytes, W B C wit h a ut o mate d 5 -part differe ntial, 
re d bl o o d cells ( R B C), a bs ol ute retic ul oc ytes, retic ul oc ytes %, Er yt hr oc yte  Mea n C or p usc ular He m o gl o bi n  (M C H ), 
Er yt hr oc yte  Mea n C or p usc ular V ol u me ( M C V ), a n d Re d Cell Distri b uti o n Wi dt h  (R D W ). 
 
S u m maries of baseli ne val ues a n d c ha n ges fr o m baseli ne will be prese nte d b y d ose le vel f or eac h assess me nt ti me 
p oi nt.  
 
Ser u m c h e mistr y a n d he mat ol o g y e val uati o ns w hic h ca n n ot be gra de d per C T C A E criteria will be s u m marize d as 
c o u nts a n d perce nta ges of pa rtici pa nts w h o were n or mal at baseli ne, b ut w h o beca me a b n or mal s u bse q ue ntl y.  
 
F or ser u m c h e mistr y a n d he mat ol o g y e v al uati o ns w hic h ca n be gra de d per C T C A E v 5. 0, t he f oll o wi n g s u m mar y ta ble 
will be create d:  
•  
S hift s u m mar y of baseli ne C T C A E gra de vers us t he  w orst o n -treat me nt C T C A E gra de ( T he hi g hest 
C T C A E gra d e d uri n g t he o n -treat me nt peri o d is c o nsi dere d as t he w orst gra de [ Gra de 0, 1, 2, 3, or 
4] f or t he s u m mar y)  
•  
S hift s u m mar y fr o m ≤ Gra de 2 at baseli ne t o ≥ Gra de 3 p ost baseli ne  
 
Cli nical la b orat or y res ul ts will be liste d b y partici pa nt . I n a d diti o n, listi n gs of a b n or mal val ues will b e pr o vi de d f or 
he mat ol o g y, c h e mistr y, c o a g ulati o n para meters. If t here is at least o ne a b n or mal assess me nt f or a n y para meter, all 
t he data f or t hat la b orat or y para meter will be i ncl u de d i nt o t he listi n g.  
8. 7.  Vit al Si g ns  
Vital si g ns ( wei g ht, te m perat ure, p ulse, res pirat or y rate, s yst olic bl o o d press ure, a n d diast olic bl o o d press ure) will be 
s u m marize d wit h c o nti n u o us descri pti ve statistics at scree ni n g, o n da y 1 of eac h treat me nt c y cle, at E O T/ Earl y 
Ter mi nati o n, a n d at Safet y F oll o w -u p visit.  Mea n c ha n ge fr o m scree ni n g ( baseli ne) will be calc ulate d f or eac h 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 3  of 4 6  
 
c y cle/c o h ort. 
 
Vital Si g ns will be liste d b y partici pa nt  a n d s u m marize d b y c o h ort a n d visit i n t he S A S.   
8. 8.  E C O G  Perf or m a nce St at u s 
E C O G Perf or ma n ce Stat us ( E C O G P S) will be assesse d  wit h t he scale descri be d i n t he pr ot oc ol A p pe n di x A, at 
scree ni n g, o n all st u d y treat me nt da y 1 of eac h c ycle,  a n d at Safet y F oll o w -U p  visit. E C O G P S at baseli ne will be 
s u m marize d, i ncl u di n g n u m ber a n d perce nta ge of partici pa nt s. 
 
8. 9.  Electr oc ar di o gr a m ( E C G)  
S u pi ne p ositi o n 1 2 -lea d E C Gs will be perf or me d at scree ni n g a n d re vie we d l ocall y at eac h visit. A n o verall 
i nter pretati o n of t he E C G res ults will be ma d e ( n or mal/a b n or mal), a n d c orrecte d Q T i nter vals, will be s u m marize d b y 
visit.  
 
9.  E X P L O R A T O R Y  A N A L Y SI S  
9. 1.  Effic ac y a n al ysis b y de m o gr a p hic s u b gr o u ps  
O R R ( pri mar y efficac y o utc o me) as defi ne d i n secti o n 7. 1. 1 will be a nal yse d b y t he f oll o wi n g de m o gra p hic 
s u b gr o u pi n g: 
•  
A ge strata:  
o  
< 6 5  years  
o  
> = 6 5 years  
•  
Se x  
•  
Race  
•  
E C O G  
•  
N u m ber of pri or re gi me ns ( 1 vs 2 , 3  a n d 4)  
•  
Disease sta ge  
9. 2.  C A -1 2 5 A n al ysis  
Fi nal i n di vi d ual s u bject res ults fr o m t he C A -1 2 5 assa y , as a p plica ble, will be prese nte d i n t he listi n gs a n d t he 
c o nce ntrati o ns will be s u m marize d b y descri pti ve statistics i n ta b ular f or m b y d ose c o h ort f or da y 1 a n d 1 5 o n c ycles 
1 -3, a n d da y 1 f or c ycle 4 a n d f urt her , i ncl u di n g Safet y F oll o w-U p  visit.  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 4  of 4 6  
 
9. 3.  Bi o m ar kers/ P h ar m ac o d y n a mic  A n al ysis  
B l o o d sa m ples f or deter mi nati o n of b i o mar kers a n d p har mac o d y na mic s ( P D) will be c ollecte d i n acc or da nce wit h t he 
sc h e d ule s pecifie d i n t he ta ble 3 2 of t he pr ot oc ol. P har mac o d y na mic s res ults i ncl u de q ua ntificati o n of peri p heral C D 4 7  
rece pt or occ u pa n c y a n d ser u m c yt o ki nes . T his a nal ysis will use data fr o m t he P har mac o d y na mics A n al ysis P o p ulati o n 
( P D P). 
 
Fi nal i n di vi d ual s u bject res ults , as a p plica ble, will be prese nte d i n t he listi n gs a n d t he res ults will be s u m marize d b y 
descri pti ve statistics i n ta b ular f or m b y d ose c o h ort f or eac h c ycle da y 1, i ncl u di n g Safet y F oll o w -U p a n d L o n g -Ter m 
F oll o w -U p visits.  A ta ble f or mea n c h a n ge  fr o m scree ni n g ( baseli ne) per c ycle will be pr o d uce d  wit h t he a p plica ble 
P D p ara meters . 
9. 4.  I m m u n o ge nicit y A n al ysis 
Fi nal i n di vi d ual s u bject res ults fr o m t he P F -0 7 9 0 1 8 0 1 A D A a n d N A b assa y , as a p pr o priate , will be prese nte d i n t he 
listi n gs a n d t he i nci de nce s u m marize d b y descri pti ve statistics i n ta b ular f or m b y c o h ort.  T his a nal ysis will use data 
fr o m t he I m m u n o ge nicit y A nal ysis P o p ulati o n (I A P) . 
 
S u m mar y ta bles t hat s h o w t he n u m ber a n d perce nta ge of s u bjects t hat fall i nt o t he f oll o wi n g cate g ories will als o be 
pr o d uce d b y st u d y p hase a n d c o h ort:  
 
Treat me nt -
i n d uce d A D A  
Baseli ne A D A titer is missi n g or ne gati ve a n d s u bject has ≥ 1 p ost -treat me nt p ositi ve A D A titer.  
Treat me nt -
b o oste d A D A  
A p ositi ve A D A res ult at baseli ne a n d t he titer ≥ 8 × baseli ne titer at least o nce after treat me nt wit h 
P F -0 7 9 0 1 8 0 1  
A D A -p ositi ve 
s u bject 
A s u bject wit h ≥ 1 treat me nt -i n d uce d or treat me nt-b o oste d A D A res p o nse.     
A D A -ne g ati ve 
s u bject 
A n A D A e v al ua ble s u bject wit h o ut treat me nt -i n d uce d or treat me nt-b o oste d A D A res p o nse. 
S u bject eit her has ( 1) all A D A -ne gati ve res ults t hr o u g h o ut t he st u d y or ( 2) is A D A p ositi ve at 
baseli ne b ut di d n ot b ec o me treat me nt -b o oste d p ost -d ose.  
A D A 
i nci de n ce 
T h e perce nt of A D A -p ositi ve s u bjects i n a treat me nt gr o u p/c o h ort or st u d y.  
A D A  
ne v er -
p ositi ve  
N o p ositi ve A D A res ults at a n y ti me p oi nt; A D A -ne gati ve patie nts (titer < c ut p oi nt)  
A D A  
e v er -
p ositi ve  
At least o ne p ositi ve A D A res ult at a n y ti me p oi nt; A D A -p os iti ve patie nts (titer ≥ c ut p oi nt) 
Treat me nt -
i n d uce d N A b  
Baseli ne N A b titer is missi n g or ne gati ve or A D A -ne gati ve a n d s u bject has ≥ 1 p ost -treat me nt 
p ositi ve N A b titer.  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 5  of 4 6  
 
Treat me nt -
b o oste d N A b  
A p ositi ve Na b res ult at baseli ne a n d t he titer ≥ 8 × baseli ne titer at least o nce after treat me nt wit h 
P F -0 7 9 0 1 8 0 1  
N A b -p ositi ve 
s u bject 
A n A D A -p ositi ve s u bject wit h ≥ 1 treat me nt -i n d uce d or treat me nt-b o oste d N A b res p o nse.  F or 
A D A -p ositi ve (treat me nt -b o oste d) s u bjects, s u bject is N A b p ositi ve o nl y if t he s u bject has ≥1 
treat me nt-i n d uce d or treat me nt-b o oste d N A b res p o nse at t he visit w here t he s u bject has a 
treat me nt-b o oste d A D A res p o nse. F or visits w here t he s u bject di d n ot s h o w a b o oste d A D A 
res p o nse, t he s u bject is classifie d as N A b-ne gati ve f or t he visit e ve n if t he s u bject has p ost -
treat me nt p ositi ve N A b titer f or t hat visit.      
N A b -ne g ati ve 
s u bject 
N A b e v al ua ble partici pa nt w h o is eit her ( 1) a n A D A -ne gati ve s u bject or ( 2) a n A D A -p ositi ve 
s u bject wit h o ut treat me nt-i n d uce d or treat me nt-b o oste d N A b res p o nse ( i.e., s u bject has all N A b-
ne g ati ve res ults t hr o u g h o ut t he st u d y or s u bject is N A b p ositi ve at baseli ne b ut di d n ot bec o me 
treat me nt-b o oste d p ost -d ose).  
N ote: i n t he e v e nt a s u bject is A D A -p ositi ve at baseli ne b ut di d n ot s h o w a b o oste d res p o nse p ost -
treat me nt, s u bject is classifie d as A D A-ne gati ve a n d N A b -ne gati ve at t he s u bject le vel e ve n if t he 
s u bject has p ost-treat me nt p ositi ve N A b titer. As s uc h all A D A-ne gati ve s u bjects are N A b -
ne g ati ve re g ar dless of N A b titer data.  
N A b i nci de n ce  T he perce nt of N A b -p ositi ve s u bjects i n a treat me nt gr o u p/c o h ort or st u d y.  
N A b  
ne v er -
p ositi ve  
N o p ositi ve N A b res ults at a n y ti me p oi nt (i ncl u di n g n o p ositi ve A D A res ults at a n y ti me p oi nt 
a n d n o N A b res ults)  
N A b  
e v er -
p ositi ve  
At least o ne p ositi ve N A b res ult at a n y ti me p oi nt 
Tra nsie nt 
A D A  
 
 
A n A D A -p ositi ve s u bject wit h ( 1) a treat me nt -i n d uce d or treat me nt-b o oste d A D A sa m ple 
detecte d o nl y at 1 sa m pli n g ti me (e xcl u di n g t he last ti me p oi nt) p ost -treat me nt, or ( 2) treat me nt-
i n d uce d or treat me nt-b o oste d A D A sa m ples detecte d at ≥ 2 ti me p oi nts w here t he first a n d last 
p ositi ve sa m ples (irres pecti ve of a n y ne gati ve sa m ples i n bet wee n) are se parate d b y < 1 6 wee ks, 
a n d t he s u bject’s last sa m ple is A D A ne gati ve.  
Persiste nt 
A D A   
I n deter mi nate 
A D A  
Tra nsie nt N A b  
A n A D A -p ositi ve s u bject wit h first a n d last p ositi ve A D A sa m ples (treat me nt -i n d uce d or 
treat me nt-b o oste d) detecte d o ver a peri o d of ≥ 1 6 wee ks p ost -treat me nt, irres pecti ve of a n y 
ne g ati ve sa m ples i n bet wee n  
A n A D A -p ositi ve s u bject w h o is n ot persiste nt or tra nsie nt 
 
Persiste nt 
N A b    
I n deter mi nate 
N A b  
A N A b -p ositi ve s u bject wit h ( 1) a treat me nt -i n d uce d or treat me nt-b o oste d N A b sa m ple detecte d 
o nl y at 1 sa m pli n g ti me (e xcl u di n g t he last ti me p oi nt) p ost -treat me nt, or ( 2) treat me nt-i n d uce d 
or treat me nt -b o oste d N A b sa m ples detecte d at ≥ 2 ti me p oi nts w here  t he first a n d last p ositi ve 
sa m ples (irres pecti ve of a n y ne gati ve sa m ples i n bet wee n) are se parate d b y < 1 6 wee ks, a n d t he 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 6  of 4 6  
 
s u bject’s last sa m ple is N A b n e gati ve or A D A ne gati ve 
A N A b -p ositi ve s u bject wit h first a n d last p ositi ve N A b sa m ples (treat me nt -i n duce d or treat me nt -
b o oste d) detecte d o ver a peri o d of ≥ 1 6 wee ks p ost -treat me nt, irres pecti ve of a n y ne gati ve 
sa m ples i n bet wee n. 
 
A N A b -p ositi ve s u bject w h o is n ot persiste nt or tra nsie nt.  
Titers will be re p orte d as me dia n, ra n ge a n d i nter q uartile ra n ge.  
 
Descri pti ve s u m maries ( mea n, sta n dar d de viati o n, me dia n, a n d ra n ge) of ti me t o A D A res p o nse will be prese nte d b y 
p hase a n d c o h ort  
 
9. 5.  P h ar m ac o ki netic A n al ysis  
9. 5. 1.  P F -0 7 9 0 1 8 0 1  a n d  P L D Ser u m C o nce ntr ati o ns  
P har mac o ki netic sa m ples f or deter mi nati o n of c o nce ntrati o n s of ser u m P F -0 7 9 0 1 8 0 1  a n d plas ma P L D  will be 
c ollecte d i n acc or da nce wit h t he re gi me n s pecifie d i n t he sc he d ule  ta ble 2 8 a n d 2 9 of t he pr ot oc ol. T he c o nce ntrati o ns 
as re p orte d b y t he bi oa n al ytical la b will be use d wit h o ut r o u n di n g f or all a nal yses.  
 
F or ser u m a n d plas ma c o nce ntrati o n data, all val ues bel o w t he li mit of q ua ntificati o n ( B L Q) will be set t o zer o 
irres pecti ve of w here t he y occ ur wit hi n a pr ofile a n d i n dicate d i n a f o ot n ote. I n di vi d ual B L Q res ults occ urri n g bet wee n 
t w o q ua ntifia ble c o nce ntrati o ns ma y be i de ntifie d as a n o mal o us c o nce ntrati o ns a n d set t o missi n g. B L Q will be 
e x cl u de d fr o m t he calc ulati o n of s u m mar y statistics. If t he maj orit y of c o nce ntrati o ns wit hi n a treat me nt gr o u p are 
B L Q, t he P K para meters ma y n ot be re p orte d f or t he tre at me nt gr o u p i n q uesti o n.  F or s u bjects wit h at least 1 
q ua ntifia ble res ult, li mite d P K para meters will be re p orte d: C ma x  a n d T ma x  will be re p orte d base d o n o nl y a si n gle 
q ua ntifia ble c o nce ntrati o n if all ot her sa m ples i n a pr ofile are B L Q.  A mi ni m u m of 3  q ua ntifia ble c o nce ntrati o ns will 
be use d t o re p ort
will be re p orte d as zer o w he n all c o nce ntrati o ns are zer o as n ote d a b o ve.  
    
 
I n s u m mar y ta bles a n d pl ots of me dia n pr ofiles, c o nce ntrati o ns will be set t o missi n g if o ne of t he f oll o wi n g cases is 
tr ue:  
1.  A c o nce ntrati o n has bee n re p orte d as N D ( i.e., n ot d o ne) or N S ( i.e., n o sa m ple)  
2.  A de viati o n i n sa m pli n g ti me is of s ufficie nt c o ncer n or a c o nce ntrati o n has bee n fla g ge d as a n o mal o us b y 
t he cli nical p har mac ol o gist. If t his is perf or me d, a f o ot n ote or ot her d oc u me ntati o n i n t he cli nical st u d y re p ort 
( C S R) detaili n g t he e x cl usi o ns will be pr o vi de d.  
 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)
C CI
C CI


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 7  of 4 6  
 
F or c o nce ntrati o ns a b o ve t he u p per li mit of q ua ntificati o n ( U L O Q), Sa m ples will be re p orte d as ( > U L Q) val ue as  well 
as t he dil uti o n rate. Dil ute d U L Q sa m ples t hat fall wit hi n assa y detecti o n li mits will be i ncl u de d i n s u m mar y statistics 
after c orrecti o n wit h dil uti o n fact or. I n t he ta bles prese nti n g s u m mar y statistics of c o nce ntrati o n -ti me series, t he t otal 
n u m ber  of val ues ( n) a n d t he n u m ber of val ues t hat are U L Q will be prese nte d t o all o w a p pr o priate i nter pretati o n of 
t he data. All v al ues will b e i ncl u de d i n s u m maries. 
 
I n di vi d ual ser u m c o nce ntrati o ns of P F-0 7 9 0 1 8 0 1 a n d P L D will be s u m marize d at eac h ti me p oi nt usi n g descri pti ve 
statistics. I n di vi d ual c o nce ntrati o n-ti me pl ots a n d me dia n data b y d ose pl ots will be pr o d uce d f or P F-0 7 9 0 1 8 0 1. F or 
P L D, b o x pl ot s u m marizi n g t he mea n/ me dia n c o nce ntrati o n b y c ycle, da y a n d n o mi nal ti me will be pr o d uce d All 
gra p hs will be prese nte d usi n g b ot h li near a n d se mi -l o garit h mic scales. T he a b o ve descri pti ve s u m mar y will be 
perf or me d f or t he P F -0 7 9 0 1 8 0 1 a n d P L D C o nce ntrati o n A nal ysis P o p ulati o n ( P C P). S u m mar y statistics ( mea n, 
me dia n, etc.) of c o nce ntrati o n -ti me data will be base d on n o mi nal sa m pli n g ti mes; sa m ples o utsi de of t he c ollecti o n 
wi n d o w s pecifie d i n t he pr ot oc ol ta ble 2 9 ( pre -d ose: wit hi n 3 0 mi n utes pri or t o i nitiati o n of P L D a n d P F -0 7 9 0 1 8 0 1 
i nf usi o n; E OI: u p t o 2 mi n after c o m pleti o n of P L D i nf usi o n a n d u p t o 5 mi n utes after c o m pleti o n of P F-0 7 9 0 1 8 0 1 
i nf usi o n; ot her ti me p oi nts: wit hi n 1 5 mi n) will be c o nsi dere d as “ missi n g” f or t he calc ulati o n of s u m mar y statistics 
o nl y.  
 
T he bel o w precisi o n will be use d f or descri pti ve a n d statistical s u m mar y of ser u m P F -0 7 9 0 1 8 0 1  a n d plas ma P L D 
c o nce ntrati o ns: 
•  
Ge o metric Mea ns, Me dia ns a n d t heir % C V a n d C o nfi de nce I nter vals ( CIs) –  1 m ore si g nifica nt 
fi g ure t ha n t he data  
•  
Sta n dar d De viati o n –  1 m ore si g nifica nt fi g ure t ha n mea ns  
•  
C V % –  w h ole n u m bers  
•  
Mi ni m u m, Ma xi m u m –  sa me si g nifica nt fi g ures as t he data  
•  
Rati os, CIs (l o g tra nsf or me d data) –  2 deci mal places  
 
All ser u m P F -0 7 9 0 1 8 0 1  a n d plas ma P L D c o nce ntrati o ns will be prese nte d i n a b y -partici pa nt  listi n g. A d diti o nall y, 
ti me ela pse d si nce d osi n g a n d de viati o n fr o m sc he d ule d ti me p oi nt will be prese nte d. In di vi d ual a n d mea n 
c o nce ntrati o n -ti me pl ots f or ser u m P F -0 7 9 0 1 8 0 1  a n d plas ma P L D will be pr o d uce d.  
9. 5. 2.  P F -0 7 9 0 1 8 0 1  a n d P L D P h ar m ac o ki netic P ar a meters  
P har mac o ki netic para meter esti mati o n will be perf or me d i n P h oe ni x ® Wi n N o nli n ® 8. 3 or hi g her ( Certara, Pri n cet o n, 
Ne w Jerse y)  o n i n di vi d ual ser u m/ plas ma c o nce ntrati o n -ti me data. T he act ual sa m pli n g ti mes will be use d f or all 
calc ulati o ns, e x ce pt as n ote d a b o ve. F or t he P K para meter calc ulati o n, B L Q ser u m c o nce ntrati o ns occ urri n g bef ore 
T ma x  will be set t o 0, wit h t he e x ce pti o n of a B L Q val ue occ urri n g bet wee n t w o meas ura ble c o nce ntrati o ns, i n w hic h 
case it will be set t o missi n g. B L Q c o nce ntrati o ns occ urri n g i n pre -d ose (tr o u g h) sa m ples d uri n g t he m ulti ple d osi n g 
p hase will be set t o zer o. P har mac o ki netic para meter esti mates a n d s u m maries will be c o m plete d f or patie nts i n t he 
P K P o p ulati o n ha vi n g s ufficie nt meas ura ble c o nce ntrati o ns t o defi ne t he P K pr ofile.  F or a n y patie nt w h ose 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 8  of 4 6  
 
e xtra p olate d  
fr o m t he last ti me p oi nt w here t he c o nce ntrati o n is a b o ve t he li mit of q ua ntificati o n t o i nfi nit y 
e x cee ds 2 0 % of t he t otal
fr o m t he patie nt will be e xcl u de d fr o m t he calc ulati o n of t he descri pti ve 
statistics. 
 
P har mac o ki netic para meter esti mates after t he si n gle d ose will i ncl u de C ma x , Tma x ,
w here a p pr o priate 
a n d as data per mit. F or t he m ulti ple d osi n g p hase,  C ma x , Tma x , Cmi n , Ca v g,
C L will be calc ulate d if 
data per mit. A d diti o nal P K p ara meters ma y be re p orte d if a p pr o priate.  
 
T he n o n -c o m part me ntal para meters will n ot be re p orte d t o a n y greater precisi o n t ha n t hat of t he c o nce ntrati o n data.  
All p ara meters will be re p orte d t o 3 si g nifica nt fi g ures.  Para meter val ues will b e r o u n de d t o t he sa me precisi o n use d 
i n data listi n gs pri or t o a n y statistical a n al ysis or descri pti ve s u m maries. 
 
T he bel o w precisi o n will be use d f or descri pti ve a n d stati stical s u m mar y of P K para meters: 
1. Ge o metric Mea ns, Me dia ns a n d t heir % C V a n d C o nfi de nce I nter vals ( CIs) –  1 m ore si g nifica nt fi g ure t ha n t he data  
2. Sta n dar d De viati o n –  1 m ore si g nifica nt fi g ure t ha n mea ns   
3. C V % –  w h ole n u m bers  
4. Mi ni m u m, Ma xi m u m –  sa me si g nifica nt fi g ures as t he data 
5. Rati os, CIs (l o g tra nsf or me d data) –  2 deci mal places  
 
F or para meters w hic h are direct ti me o bser vati o ns, m e dia n a n d ra n ge will ha ve t he sa me si g nifica nt fi g ures as t he data  
T he defi niti o ns a n d t he ass ociate d r ules f or t he P K para meter calc ulati o n are s u m marize d i n t he ta ble bel o w: 
 
C ma x  
Ma xi m u m o bser ve d c o nce ntrati o n, occ urri n g at ti me T
ma x . If all o bser vati o ns are bel o w t he 
li mit of q ua ntificati o n ( B L Q), Cma x  will be re p orte d as zer o.  
T ma x  
Ti me of ma xi m u m o bser ve d c o nce ntrati o n. If t he ma xi m u m o bser ve d c o nce ntrati o n is n ot 
u ni q ue, t he n t he first ma xi m u m is use d. If all o bser vati o ns are B L Q, T ma x  will be re p orte d as 
n ot d eter mi ne d ( N D).  
C mi n  
Mi ni m u m o bser ve d c o nce ntrati o n occ urri n g at ti me T
mi n . 
Rac ( M ulti ple 
d osi n g)                       
O bser ve d acc u m ulati o n rati o will be calcl uate d as: Rac = A U Cτ,ss / A U Cτ,(first d ose).   
C L  
A n esti mate of t otal b o d y cleara nce c o m p ute d fr o m  t he stea d y state data, calc ulate d as 
D ose/
. 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 3 9  of 4 6  
 
C a v g 
A vera g e c o nce ntrati o n d uri n g a d osi n g i nter val, calc ulate d as 
di vi de d b y ta u.  
 
T he calc ulate d P K p ara meters will be s u m marize d usi n g descri pti ve statistics, i ncl u di n g arit h metic a n d ge o metric 
mea ns, S D, arit h metic a n d ge o metric % C V, me dia n, mi ni m u m, a n d ma xi m u m. F or T
ma x  o nl y t he me dia n a n d t he 
ra n ge will be re p orte d. All d ata will be s u m marize d b y s u bject, d ose, c o h ort a n d t he st u d y p hase.  
 
D ose pr o p orti o nalit y will als o be assesse d base d o n t he data ac q uire d d uri n g t he d ose escalati o n p hase usi n g 
descri pti ve statistics.  
 
E x pl orat or y a n al ysis ma y be c o n d ucte d o n t he relati o ns hi p be t wee n P F -0 7 9 0 1 8 0 1 e x p os ure a n d vari o us P D, safet y 
a n d efficac y varia bles.  
 
P F -0 7 9 0 1 8 0 1 ser u m c o nce ntrati o ns a n al yze d usi n g p o p ulati o n P K a p pr oac hes. I n a d diti o n, a m o del -base d a p pr oac h 
ma y be use d t o e x pl ore t he p ote ntial relati o ns hi p bet wee n P F -0 7 9 0 1 8 0 1 e x p os ure metrics a n d efficac y, safet y, 
a n d/ or bi o mar ker e n d p oi nts a n d re p orte d se p aratel y. T hese a nal yses, if c o n d ucte d, will be re p orte d i n se parate 
re p ort(s). 
 
 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)
C CI


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 4 0  of 4 6  
 
1 0.  R E F E R E N C E S  
Eise n ha u er E A, T herasse P, B o gaerts J et al. Ne w res p o nse e val uati o n criteria i n s o li d t u m o urs: re vise d R E CI S T 
g ui deli ne ( versi o n 1. 1). E ur J Ca n cer 2 0 0 9; 4 5: 2 2 8 -2 4 7.  
 
 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 4 1  of 4 6  
 
1 1.  A P P E N DI X 1:   T A B L E O F C O N T E N T O F T A B L E S , L I S TI N G S A N D F I G U R E S 
T he f oll o wi n g titles descri be pla n ne d o ut p uts (s u m mar y ta bles, listi n gs, a n d fi g ures) f or t he statistical a nal ysis.  
 
T he c o n ve nti o n f oll o we d i n t he list of titles is t o i ncl u de e n o u g h i nf or mati o n t o i de ntif y  t he o ut p uts u ni q uel y, a n d t o i n dicate t he a n al ysis p o p ulati o n fr o m w hic h 
t he c o ntri b uti n g data are dra w n (if a p plica ble).  C o m me ntar y a d ds detail t o ai d t he c o nstr ucti o n of t he i nte n de d o ut p uts w he n t he title mi g ht n ot be s ufficie nt t o li n k 
t he ta ble, listi n g or fi g ure wit h t he rele v a nt secti o n of t his S A P te xt or mi g ht n ot f ull y re prese nt its c o nte nt. 
 
O ut p uts ma y be c o m bi ne d or di vi de d, a n d title details ma y be m o difie d d uri n g de vel o p me nt, if s paci n g a n d a p peara n ce re q uire d oi n g s o. A d diti o nal o ut p uts ma y 
be pr o d uce d if nee de d b y c ollecte d data.  
 
If a n o ut p ut i n t his a p pe n di x is n ot pr o d uce d beca use it w o ul d n ot be i nf or mati ve (f or e xa m ple, w he n t w o a nal ysis p o p ulati o ns  c o n ver ge or n o i nf or mati o n is 
c ollecte d), t hat c h a n ge i n t he set of data dis pla ys will  be ac k n o wle d ge d i n t he C S R.  
 
T he A nal ysis P o p ulati o ns, as defi ne d i n Secti o n 5 . 6, are Safet y A nal ysis Set ( S A S), D L T -E val ua ble P o p ulati o n ( D L P), P F -0 7 9 0 1 8 0 1 / P L D  C o nce ntrati o n A nal ysis 
P o p ulati o n ( P C P), I m m u n o ge nicit y A nal ysis P o p ulati o n (I A P) , a n d P har m ac o d y na mics A nal ysis P o p ulati o n ( P D P) . 
 
Ref. 
#  
T a ble Title a n d S u btitle  
A n al ysis 
P o p ul ati o n  
1  
A nal ysis P o p ulati o n, N u m ber ( %) of Partici pa nt s 
All 
scree ne d 
2  
Partici pa nt s Dis p ositi o n, N u m ber ( %) of Partici pa nt s  
S A S  
3  
De m o gra p hic a n d Baseli ne C haracteristics  
S A S  
4  
Me dical Hist or y, N u m ber ( %) of Partici pa nt s  
S A S  
5  
Ca n cer Hist or y, N u m ber ( %) of Partici pa nt s  
S A S  
6  
Pri or Treat me nts f or C urre nt Dia g n osis, N u m ber ( %) of Partici pa nt s  
S A S  
7  
Pri or S ur geries f or C urre nt Dia g n osis, N u m ber ( %) of Partici pa nt s  
S A S  
8  
C o nc o mita nt Me dicati o ns, N u m ber ( %) of Partici pa nt s  
S A S  
9  
C o nc o mita nt Pr oce d ure, N u m ber ( %) of Partici pa nt s  
S A S  
1 0  
E x p os ure t o P F -0 7 9 0 1 8 0 1  
S A S  
1 1  
E x p os ure t o P L D  
S A S  
1 2  
E x p os ure t o P F -0 7 9 0 1 8 0 1  ( S u bjects wit h D ose Re d uc ti o n) 
S A S  
1 3  
E x p os ure t o P L D ( S u bjects wit h D ose Re d uc ti o n) 
S A S  
1 4  
D ose Dela y, Re d ucti o n, I nterr u pti o n or Per ma ne nt Wit h dra wal, N u m ber ( %) of Partici pa nt s 
S A S  
1 5  
S u m mar y of B O R  
S A S  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 4 2  of 4 6  
 
1 6  
S u m mar y of D urati o n of Res p o nse  
S A S  
1 7  
S u m mar y of Pr o gressi o n Free S ur vi val  
S A S  
1 8  
S u m mar y of O verall S ur vi val  
S A S  
1 9  
S u m mar y of D ose Li miti n g T o xicit y, b y S yste m Or ga n Class, Preferre d Ter m, a n d Ma xi m u m Se verit y, N u m ber ( %) of Partici pa nt s 
D L P  
2 0  
O verall S u m mar y of Treat me nt E mer ge nt A d verse E ve nts ( T E A E), N u m ber ( %) of Partici pa nt s 
S A S  
2 1  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts (a n y gra de a n d gra de ≥ 3) b y S yste m Or ga n Class a n d Preferre d Ter m, N u m ber ( %)  of 
Partici pa nt s 
S A S  
2 2  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts (a n y gra de a n d gra de ≥ 3) b y S yste m Or ga n Class a n d Preferr e d Ter m –  Relate d t o 
P F -0 7 9 0 1 8 0 1  o nl y, N u m ber ( %) of Partici pa nt s 
S A S  
2 3  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts (a n y gra de a n d gra de ≥ 3) b y S yste m Or ga n Class a n d Preferre d Ter m –  Relate d t o 
P L D  o nl y, N u m ber ( %) of Partici pa nt s 
S A S  
2 4  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts (a n y gra de a n d gra de ≥ 3) b y S yste m Or ga n Class a n d Preferre d Ter m –  Relate d t o 
B ot h P F -0 7 9 0 1 8 0 1  a n d P L D , N u m ber ( %) of Partici pa nt s 
S A S  
2 5  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts (a n y gra de a n d gra de ≥ 3) b y S yste m Or ga n Class a n d Preferre d Ter m –  Relate d t o 
a n y St u d y Dr u g, N u m ber ( %) of Partici pa nt s 
S A S  
2 6  
I nci de n ce of Seri o us Treat me nt E mer ge nt A d verse E ve nts b y S yste m Or ga n Class a n d Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
2 7  
I nci de n ce of Seri o us Treat me nt E mer ge nt A d verse E ve nts b y S yste m Or ga n Class a n d Preferre d Ter m –  Relate d t o P F -0 7 9 0 1 8 0 1  o nl y, 
N u m ber ( %) of Partici pa nt s 
S A S  
2 8  
I nci de n ce of Seri o us Treat me nt E mer ge nt A d verse E ve nts b y S yste m Or ga n Class a n d Preferre d Ter m –  Relate d t o P L D  o nl y, N u m ber 
( %) of Partici pa nt s 
S A S  
2 9  
I nci de n ce of Seri o us Treat me nt E mer ge nt A d verse E ve nts b y S yste m Or ga n Class a n d Preferre d Ter m –  Relate d t o b ot h P F -0 7 9 0 1 8 0 1  
a n d P L D , N u m ber ( %) of Partici pa nt s 
S A S  
3 0  
I nci de n ce of Seri o us Treat me nt E mer ge nt A d verse E ve nts b y S yste m Or ga n Class a n d Preferre d Ter m –  Relate d t o a n y st u d y dr u g, 
N u m ber ( %) of Partici pa nt s 
S A S  
3 1  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts Lea di n g t o A n y St u d y Dr u g Per ma ne nt Disc o nti n uati o n b y S yste m Or ga n Class a n d 
Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
3 2  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts Lea di n g t o P F-0 7 9 0 1 8 0 1  Per ma ne nt Disc o nti n uati o n b y S yste m Or ga n Class a n d 
Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
3 3  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts Lea di n g t o P L D  Per ma ne nt Disc o nti n uati o n b y S yste m Or ga n Class a n d Preferre d 
Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
3 4  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts Lea di n g t o Per ma ne nt Disc o nti n uati o n of P L D  a n d P F-0 7 9 0 1 8 0 1  b y S yste m Or ga n 
Class a n d Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
3 5  
I nci de n ce of Treat me nt-relate d (relate d t o P F-0 7 9 0 1 8 0 1  o nl y) Treat me nt E mer ge nt A d verse E ve nts Lea di n g t o P F -0 7 9 0 1 8 0 1  Per ma n e nt 
Disc o nti n uati o n b y S yste m Or ga n Class a n d Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
3 6  
I nci de n ce of Treat me nt-relate d (relate d t o P L D  o nl y) Treat me nt E mer ge nt A d verse E ve nts Lea di n g t o P L D  Per ma n e nt Disc o nti n uati o n 
b y S yste m Or ga n Class a n d Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 4 3  of 4 6  
 
3 7  
I nci de n ce of Treat me nt-relate d (t o b ot h dr u gs) Treat me nt E mer ge nt A d verse E ve nts Lea di n g t o Per ma n e nt Disc o nti n uati o n of B ot h P L D  
a n d P F-0 7 9 0 1 8 0 1  b y S yste m Or ga n Class a n d Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
3 8  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts Res ulti n g i n P F -0 7 9 0 1 8 0 1  D ose I nterr u pti o n b y S yste m Or ga n Class a n d Preferre d 
Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
3 9  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts Res ulti n g i n P L D  D ose I nterr u pti o n b y S yste m Or ga n Class a n d Pref erre d Ter m, 
N u m ber ( %) of Partici pa nt s 
S A S  
4 0  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts Res ulti n g i n P F-0 7 9 0 1 8 0 1  D ose Re d ucti o n b y S yste m Or ga n Class a n d Preferre d 
Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
4 1  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts Res ulti n g i n P L D  D ose Re d ucti o n b y S yste m Or ga n Class a n d Preferre d Ter m, 
N u m ber ( %) of Partici pa nt s 
S A S  
4 2  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts Res ulti n g i n Deat h b y S yste m Or ga n Class a n d Preferre d Ter m, N u m ber ( %) of 
Partici pa nt s 
S A S  
4 3  
I nci de n ce of Treat me nt-relate d ( Relate d t o P F-0 7 9 0 1 8 0 1  o nl y) Treat me nt E mer ge nt A d verse E ve nts Res ulti n g i n Deat h b y S yste m 
Or ga n Class a n d Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
4 4  
I nci de n ce of Treat me nt-relate d ( Relate d t o P L D  o nl y) Treat me nt E mer ge nt A d verse E ve nts Res ulti n g i n Deat h b y S yste m Or g a n Class 
a n d Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
4 5  
I nci de n ce of Treat me nt-relate d ( Relate d t o B ot h Dr u gs) Treat me nt E mer ge nt A d verse E ve nts Res ulti n g i n Deat h b y S yste m Or ga n Class 
a n d Preferre d Ter m, N u m ber ( %) of Partici pa nt s 
S A S  
4 6  
I nci de n ce of Treat me nt E mer ge nt A d verse E ve nts b y S yste m Or ga n Class, Preferre d Ter m a n d Ma xi m u m Se verit y, N u m ber ( %) of 
Partici pa nt s 
S A S  
4 7  
S u m mar y of Deat h  
S A S  
4 8  
S hift Ta ble fr o m Baseli ne i n C he mistr y Para meters, N or mal t o A b n or mal ( n o C T C A E gra de d para meters)  
S A S  
4 9  
S hift Ta ble fr o m Baseli ne t o W orst O n -Treat me nt  C T C A E Gra de i n C he mistr y Para meters  
S A S  
5 0  
S hift Ta ble fr o m C T C A E G ra d e ≤ 2 at Baseli ne t o ≥ 3 P ost baseli ne i n C he mistr y Para meters 
S A S  
5 1  
S hift Ta ble fr o m Baseli ne i n He m at ol o g y Para meters, N or mal t o A b n or mal ( n o C T C A E gra de d para meters)  
S A S  
5 2  
S hift Ta ble fr o m Baseli ne t o W orst O n-Treat me nt  C T C A E Gra de i n He mat ol o g y Para meters  
S A S  
5 3  
S hift Ta ble fr o m C T C A E Gra d e ≤ 2 at Baseli ne t o ≥ 3 P ost baseli ne i n He mat ol o g y Para meters 
S A S  
5 4  
S u m mar y of Ne wl y Occ urri n g or W orse ni n g ( C T C A E gra de) A b n or malities d uri n g t he O n -Treat me nt i n He m at ol o g y Para meters  
S A S  
5 5  
Mea n a n d C ha n ge i n Vital Si g ns O ver Ti me  
S A S  
5 6  
E C G A b n or malities, N u m ber ( %) of Partici pa nt s 
S A S  
5 7  
C A -1 2 5 C o nce ntrati o ns, b y D ose C o h ort a n d C ycle  
P D P  
5 8  
P har mac o d y na mic Bi o mar kers C o nce ntrati o ns, b y D ose C o h ort a n d C ycle  
P D P  
5 9  
Mea n C ha n ge i n P har mac o d y na mic Bi o mar kers , b y D ose C o h ort a n d C ycle 
P D P  
6 0  
I nci de n ce a n d D urati o n of A D A a n d N A b, b y D ose C o h ort  
I A P 
6 1  
Ser u m P F -0 7 9 0 1 8 0 1  C o nce ntrati o n s, b y D ose C o h ort, Visit a n d Ti me p oi nt: S u m mar y Statistics  
P C P  
6 2  
Ser u m P L D C o nce ntrati o n s, b y D ose C o h ort, Visit a n d Ti me p oi nt: S u m mar y Statistics  
P C P  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 4 4  of 4 6  
 
6 3  
P F -0 7 9 0 1 8 0 1  P K Para meters , b y D ose C o h ort, Visit a n d Ti me p oi nt: S u m mar y Statistics   
P C P  
6 4  
P L D P K Para meters , b y D ose C o h ort, Visit a n d Ti me p oi nt: S u m mar y Statistics  
P C P  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 4 5  of 4 6  
 
Ref. 
#  
Listi n g Title  
A n al ysis P o p ul ati o n  
1  
Listi n g of A nal ysis P o p ulati o n  
All scree ne d  
2  
Listi n g of Partici pa nt  Dis p ositi o n  
S A S  
3  
Listi n g of Pr ot oc ol De viati o ns  
S A S  
4  
Listi n g of De m o gra p hic C haracteristics  
S A S  
5  
Listi n g of Ca n cer Hist or y  
S A S  
6  
Listi n g of Pri or Treat me nts f or C urre nt Dia g n osis  
S A S  
7  
Listi n g of C o nc o mita nt Me dicati o ns  
S A S  
8  
Listi n g of C o nc o mita nt Pr oce d ures  
S A S  
9  
Listi n g of A d mi nistrati o n of P F -0 7 9 0 1 8 0 1  
S A S  
1 0  
Listi n g of A d mi nistrati o n of P L D  
S A S  
1 1  
Listi n g of Reas o ns f or Misse d D oses  
S A S  
1 2  
Listi n g of T u m or Res p o nse Assess me nts: Tar get, N o n -Tar get a n d Ne w Lesi o ns  
S A S  
1 3  
Listi n g of T u m or Res p o nse Assess me nt  
S A S  
1 4  
Listi n g of D ose Li miti n g T o xicit y  
D L P  
1 5  
Listi n g of A d verse E ve nts  
S A S  
1 6  
Listi n g of Deat hs  
S A S  
1 7  
Listi n g of A d verse E ve nts Lea di n g t o Deat h  
S A S  
1 8  
Listi n g of Cli nical La b orat or y Test Res ults  
S A S  
1 9  
Listi n g of E C O G  
S A S  
2 0  
Listi n g of C A -1 2 5 C o nce ntrati o ns  
P D P  
2 1  
Listi n g of P har mac o d y na mic Bi o mar kers C o nce ntrati o ns  
P D P  
2 2  
Listi n g of A D A a n d N A b  
I A P 
2 3  
Listi n g of P F -0 7 9 0 1 8 0 1  Ser u m C o nce ntrati o ns  
P C P  
2 4  
Listi n g of P L D  Plas ma C o nce ntrati o ns  
P C P  
2 5  
Listi n g of P F -0 7 9 0 1 8 0 1  P K Para meters  
P C P  
2 6  
Listi n g of P L D  P K Para meters  
P C P  
 
 
 
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)


 
St atistic al A n al ysis Pl a n  
Pfizer I nc. / Pr ot oc ol: C 4 9 7 1 0 0 2  ( T TI-6 2 2 -0 2)  
I Q VI A Bi otec h ( C o nfi de ntial) Pr oject # Z Z A 8 2 3 9 7 
T e m pl at e N o. : N V A _ T P _ C R 6 9 4 R e vi si o n 4  
C O N FI D E N TI A L  
T e m pl at e  Eff e cti v e D at e: 1 5 F e b 2 0 2 3  
R ef er e n c e: S O P C R 0 0 8 , W P C R 0 1 3  
 
P a g e 4 6  of 4 6  
 
 
 
 
Ref. 
#  
Fi g ures Title  
A n al ysis P o p ul ati o n  
1  
Waterfall Pl ot of C ha n ge i n T u m or Size fr o m Baseli ne t o Partici pa nt s’ Best T u m or Res p o nse at A n y Ti me P oi nt 
S A S  
2  
S wi m mer Pl ot of T u m or Res p o nse  
S A S  
3  
S pa g hetti Pl ot of T u m or Res p o nse  
S A S  
4  
Ka pla n -Meier A nal ysis of Pr o gressi o n Free S ur vi val  
S A S  
5  
Ka pla n -Meier A nal ysis of O verall S ur vi val  
S A S  
6  
I n di vi d ual P F -0 7 9 0 1 8 0 1  C o nce ntrati o ns O ver Ti me ( Li near a n d Se mi -l o g Pl ots)  
P C P  
7  
Mea n a n d Me dia n  P F -0 7 9 0 1 8 0 1  C o nce ntrati o ns O ver Ti me b y D ose C o h ort ( Li near a n d Se mi -l o g Pl ots)  
P C P  
8  
I n di vi d ual P L D  C o nce ntrati o ns O ver Ti me ( Li near a n d Se mi -l o g Pl ots)  
P C P  
9  
Mea n a n d Me dia n  P L D C o nce ntrati o ns O ver Ti me b y D ose C o h ort ( Li near a n d Se mi -l o g Pl ots)  
P C P  
0 9 0 1 7 7 e 1 a 0 d 2 3 9 5 b\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 4 2 3: 1 6 ( G M T)