A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07209960 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Phase: PHASE1
Conditions: Non-small-cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Urothelial Carcinoma, Colorectal Carcinoma, Ovarian Carcinoma
Sponsor: Pfizer

PF-07209960 
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PFIZER CONFIDENTIAL 
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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. 
 
 
 
 
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE 
SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND 
ANTI-TUMOR ACTIVITY OF PF-07209960 IN PARTICIPANTS WITH 
ADVANCED OR METASTATIC SOLID TUMORS 
 
 
Study Intervention Number: 
PF-07209960 
Study Intervention Name: 
N/A 
US IND Number: 
CCI 
 
 
EudraCT Number: 
N/A 
Protocol Number: 
C4011001 
Phase: 
1 
Short Title: Phase 1 Study of PF-07209960 in Advanced or Metastatic Solid Tumors 
 
 

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 Final Protocol Amendment 1, 30 October 2020 
 
 
Protocol Amendment Summary of Changes Table 
 
Document History 
Document 
Version Date 
Summary and Rationale for Changes 
Original 
rotocol 
15 September 2020 
NIA 
Amendment 1 
30 October 2020 
The prima1y purpose of the amendment is to 
incorporate feedback received from the United 
States (US) Food and Dmg Administration (FDA). 
In addition, clarifications, administrative and 
typographical modifications were made to improve 
upon the consistency of the protocol. 
Schedule of Activities (SOA) 
• 
 C1D15 outpatient post-infusion PF-07209960 
IV administration monitoring time has been 
extended from 1 hour to 8 hours. Paiiicipants 
may not be released until the investigator has 
confnmed the pa1iicipant has not exhibited 
signs and symptoms of a cytokine reaction. 
• 
 Day 22 visit window is clai·ified to be ±24 
hours for consistency. 
Section 1.3.1 SOA for PK/PD: 
• 
Clai·ification added to Notes column that if 
CRS is suspected, additional PK/PD and 
cytokine samples should be collected 
immediately. 
• 
 Note added to clarify that if treatment is 
be ond C cle 3 the last blood sam les 
Section 1.3.2 SOA for EQT/Follow-Up: 
• 
AE collection window extended to 90 days 
(from 28 days) after the last dose of study 
intervention due to possible late onset of AE. 
• 
 Note added to clarify the collection of con- 
meds/interventions at EOT/Withdrawal Visit. 
Section 2.3.1 Risk Assessment 
• 
Additional language added to clai·ify that for 
C1D15 PF-07209960 IV administration, 

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Document History 
Document 
Version Date 
Summary and Rationale for Changes 
participants should remain at the 
investigational sites for observation for at least 
8-hours post dose. 
Section 5.1 Inclusion Criteria (IC): 
• IC #2 sub-criteria revised to clarify that 
anti-PD-1 wash-out period is required for all 
participants and not just for Part 2. 
• IC #2 sub-criterion (now sub-criterion “e”) 
was revised to clarify that participants with 
OvCa or MSS CRC must not have received 
either anti-PD-1 or anti-PD-L1. 
• IC #7 – the method for estimating CrCl has 
been clarified to indicate the use of the 
Cockcroft-Gault method, as specified by the 
FDA. 
Section 5.2 Exclusion Criteria (EC): 
• EC #5 – Clarification that anti-PD-1 wash-out 
period is required for all participants and not 
just for Part 2. 
Section 4.3.3 Dose Limiting Toxicity Definition: 
• Updated definition to include “at least possible 
related to PF-07209960” as requested by the 
FDA. 
• All Grade ≥3 non-hematologic treatment- 
related AEs are DLTs with limited exceptions 
if they can be controlled with or without 
medical therapy and improve within 72 hours. 
The exceptions list was updated to include 
Grade 3 hypertension, hypotension, CRS, rash, 
and ISR as DLTs as specified by the FDA. 
• Sub-bullet #1 under Immune related AE (irAE) 
that meet the following criterion was updated 
to include the grade of toxicity for irAE 
regardless of duration. 

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Document History 
Document 
Version Date 
Summary and Rationale for Changes 
• Sub-bullet #7 under Immune related AE (irAE) 
that meet the following criterion was rewritten 
as a sub-bullet instead of a standalone 
exception. 
Section 4.3.6 RP2D Definition: 
• Added language to clarify that the occurrence 
of significant AEs that occur after the DLT 
observation period such as late-onset irAEs 
will be reviewed in context of all safety data 
available when determining the MTD/RP2D 
for Part 2 expansion phase. 
Section 8.3.5.1 Exposure During Preganancy 
• Details of EDP pregnancy report will be 
collected until 4 months after the last dose 
instead of 28 days. 
Section 10.4 Appendix 4: Contraceptive 
Guidance 
• Contraception period for males and females is 
extended from 28 days to a more conservative 
period of 4 months following last dose of study 
drug (>5 half-lives of the projected terminal 
half-life of study drug in humans) based on 
FDA recommendation. 

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TABLE OF CONTENTS 
LIST OF TABLES .................................................................................................................. 11 
1. PROTOCOL SUMMARY .................................................................................................. 12 
1.1. Synopsis .................................................................................................................. 12 
1.2. Schema .................................................................................................................... 20 
1.3. Schedule of Activities ............................................................................................. 21 
1.3.1. Schedule of Activities: Pharmacokinetic, Blood Pharmacodynamic, 
Immunophenotyping, and Cytokine Activity ................................................. 30 
1.3.2. Schedule of Activities: End of Treatment, Post-Treatment, and 
Survival Follow-up .......................................................................................... 32 
2. INTRODUCTION ............................................................................................................... 35 
2.1. Study Rationale ....................................................................................................... 35 
2.2. Background ............................................................................................................. 35 
2.2.1. Nonclinical Pharmacology ......................................................................... 37 
2.2.2. Nonclinical Pharmacokinetics and Metabolism ......................................... 38 
2.2.3. Nonclinical Safety ...................................................................................... 38 
2.2.4. Clinical Overview ...................................................................................... 38 
2.3. Benefit/Risk Assessment ........................................................................................ 41 
2.3.1. Risk Assessment ........................................................................................ 42 
2.3.2. Benefit Assessment .................................................................................... 44 
2.3.3. Overall Benefit/Risk Conclusion ............................................................... 44 
3. OBJECTIVES AND ENDPOINTS .................................................................................... 44 
4. STUDY DESIGN ................................................................................................................ 46 
4.1. Overall Design ........................................................................................................ 46 
4.2. Scientific Rationale for Study Design .................................................................... 48 
4.3. Justification for Dose .............................................................................................. 48 
4.3.1. Starting Dose .............................................................................................. 49 
4.3.1.1. Subcutaneous Dosing ............................................................... 49 
4.3.1.2. Alternative IV Dosing .............................................................. 49 
4.3.2. Criteria for Dose Escalation ....................................................................... 50 
4.3.2.1. Criteria for Intraparticipant Dose Escalation ............................ 51 
4.3.3. Dose Limiting Toxicity Definition ............................................................. 52 
4.3.4. Maximum Tolerated Dose Definition ........................................................ 53 

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4.3.5. Maximum Feasible Dose Definitions ......................................................... 53 
4.3.6. Recommended Phase 2 Dose Definition ..................................................... 54 
4.4. End of Study Definition ........................................................................................... 54 
5. STUDY POPULATION ...................................................................................................... 54 
5.1. Inclusion Criteria ..................................................................................................... 55 
5.2. Exclusion Criteria .................................................................................................... 57 
5.3. Lifestyle Considerations .......................................................................................... 60 
5.3.1. Contraception .............................................................................................. 60 
5.4. Screen Failures ......................................................................................................... 60 
6. STUDY INTERVENTION .................................................................................................. 60 
6.1. Study Intervention(s) Administered ......................................................................... 61 
6.1.1. Administration ............................................................................................. 61 
6.2. Preparation/Handling/Storage/Accountability .......................................................... 62 
6.2.1. Preparation and Dispensing ......................................................................... 63 
6.3. Measures to Minimize Bias: Randomization and Blinding ..................................... 63 
6.3.1. Allocation to Study Intervention ................................................................. 63 
6.4. Study Intervention Compliance ............................................................................... 64 
6.5. Concomitant Therapy .............................................................................................. 64 
6.5.1. Other Anti-tumor/Anti-cancer or Experimental Drugs ............................... 65 
6.5.2. Radiation Therapy ....................................................................................... 65 
6.5.3. Supportive Care ........................................................................................... 65 
6.5.4. Hematopoietic Growth Factors ................................................................... 65 
6.5.5. Anticoagulation Therapy ............................................................................. 66 
6.5.6. Anti-Diarrheal, Anti-Emetic Therapy ......................................................... 66 
6.5.7. Anti-Inflammatory Therapy. ....................................................................... 66 
6.5.8. Corticosteroids ............................................................................................ 66 
6.5.9. Surgery ........................................................................................................ 66 
6.5.10. Transfusion Support .................................................................................. 67 
6.5.11. Management of Potential Study Intervention-Related Toxicities ............. 67 
6.5.11.1. Cytokine Release Syndrome .................................................... 67 
6.5.11.2. Injection Site Reactions: .......................................................... 67 
6.5.11.3. Hypersensitivity Reactions Types 1 and 3: ............................. 67 

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6.5.11.4. Infusion Related Reactions ..................................................... 68 
6.5.11.5. Immune-Related Adverse Events ........................................... 68 
6.6. Dose Modification .................................................................................................. 68 
6.6.1. Dosing Interruptions ................................................................................... 69 
6.6.2. Dose Delays ............................................................................................... 69 
6.6.3. Dose Reductions ......................................................................................... 70 
6.7. Intervention After the End of the Study ................................................................. 71 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ......................................................................... 71 
7.1. Discontinuation of Study Intervention .................................................................... 71 
7.2. Participant Discontinuation/Withdrawal From the Study ...................................... 72 
7.2.1. Withdrawal of Consent .............................................................................. 72 
7.3. Lost to Follow-up ................................................................................................... 73 
8. STUDY ASSESSMENTS AND PROCEDURES .............................................................. 73 
8.1. Efficacy Assessments ............................................................................................. 74 
8.1.1. Tumor Response Assessments ................................................................... 74 
8.2. Safety Assessments ................................................................................................. 75 
8.2.1. Physical Examinations ............................................................................... 75 
8.2.2. Vital Signs .................................................................................................. 75 
8.2.3. Electrocardiograms ..................................................................................... 76 
8.2.4. Echocardiogram or MUGA ........................................................................ 77 
8.2.5. Clinical Safety Laboratory Assessments .................................................... 77 
8.2.6. Safety Imaging Assessments ...................................................................... 77 
8.2.7. Pregnancy Testing ...................................................................................... 77 
8.2.8. Fertility Perservation .................................................................................. 78 
8.2.9. Inpatient Monitoring .................................................................................. 78 
8.2.10. Local Site Injection Tolerability Assessment (SC Only) ......................... 78 
8.2.11. One-Month Follow-up Visit ..................................................................... 79 
8.2.12. Survival Follow-up .................................................................................. 79 
8.3. Adverse Events and Serious Adverse Events ......................................................... 80 
8.3.1. Time Period and Frequency for Collecting AE and SAE Information ...... 80 
8.3.1.1. Reporting SAEs to Pfizer Safety .............................................. 81 
8.3.2. Method of Detecting AEs and SAEs ........................................................... 81 

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8.3.3. Follow-up of AEs and SAEs ....................................................................... 81 
8.3.4. Regulatory Reporting Requirements for SAEs ........................................... 82 
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational 
Exposure ........................................................................................................... 82 
8.3.5.1. Exposure During Pregnancy ...................................................... 82 
8.3.5.2. Exposure During Breastfeeding ................................................. 84 
8.3.5.3. Occupational Exposure .............................................................. 84 
8.3.6. Cardiovascular and Death Events ................................................................ 84 
8.3.7. Disease Related Events and/or Disease Related Outcomes Not 
Qualifying as AEs or SAEs .............................................................................. 84 
8.3.8. Adverse Events of Special Interest ............................................................. 85 
8.3.8.1. Lack of Efficacy ........................................................................ 85 
8.3.9. Medical Device Deficiencies ...................................................................... 85 
8.3.10. Medication Errors ...................................................................................... 85 
8.4. Treatment of Overdose ............................................................................................ 86 
8.5. Pharmacokinetics ..................................................................................................... 87 
8.5.1. Analysis of PF-07209960 ............................................................................ 87 
8.6. Pharmacodynamics .................................................................................................. 87 
8.7. Genetics ................................................................................................................... 88 
8.7.1. Specified Genetics ....................................................................................... 88 
8.7.2. Banked Biospecimens for Genetics ............................................................. 88 
8.8. Biomarkers ............................................................................................................... 88 
8.8.1. Archival/De Novo Tumor Biopsies............................................................. 88 
8.8.2. Whole Blood, Plasma, Serum ..................................................................... 89 
8.9. Immunogenicity Assessments ................................................................................. 89 
8.10. Health Economics .................................................................................................. 90 
9. STATISTICAL CONSIDERATIONS ................................................................................. 90 
9.1. Statistical Hypotheses .............................................................................................. 90 
9.2. Sample Size Determination ..................................................................................... 90 
9.2.1. Part 1: Dose Escalation ............................................................................... 90 
9.2.2. Part 2: Dose Expansion ............................................................................... 91 
9.3. Analysis Sets ............................................................................................................ 92 
9.4. Statistical Analyses ................................................................................................. 93 

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9.4.1. Maximum Tolerated Dose Determination .................................................. 93 
9.4.1.1. Stopping Criteria ....................................................................... 94 
9.4.2. Efficacy Analysis ....................................................................................... 95 
9.4.3. Pharmacokinetic Analysis .......................................................................... 96 
9.4.3.1. Single-Dose and Steady-State PF-07209960 
Pharmacokinetic Analysis ................................................................. 96 
9.4.4. Analysis of Immunogenicity Data.............................................................. 96 
CCI 
 
9.4.6. Other Safety Analyses ................................................................................ 96 
9.4.6.1. Electrocardiogram Analyses ..................................................... 97 
9.4.6.2. Adverse Events ......................................................................... 98 
9.4.6.3. Laboratory Test Abnormalities ................................................. 98 
9.4.7. Other Analyses ........................................................................................... 98 
9.4.7.1. Analysis of Biomarker Endpoints ............................................. 98 
9.4.7.2. Population Pharmacokinetic Analysis or PK/PD Modeling ..... 99 
9.5. Interim Analyses ..................................................................................................... 99 
9.6. Data Monitoring Committee or Other Independent Oversight Committee ............ 99 
10. SUPPORTING  DOCUMENTATION  AND  OPERATIONAL 
CONSIDERATIONS ...................................................................................................... 100 
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations ............. 100 
10.1.1. Regulatory and Ethical Considerations .................................................. 100 
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP ...................................................................... 100 
10.1.2. Financial Disclosure ............................................................................... 101 
10.1.3. Informed Consent Process ..................................................................... 101 
10.1.4. Data Protection ....................................................................................... 102 
10.1.5. Dissemination of Clinical Study Data .................................................... 102 
10.1.6. Data Quality Assurance .......................................................................... 103 
10.1.7. Source Documents ................................................................................. 105 
10.1.8. Study and Site Start and Closure ............................................................ 105 
10.1.9. Publication Policy .................................................................................. 106 
10.1.10. Sponsor’s Qualified Medical Personnel ............................................... 106 
10.2. Appendix 2: Clinical Laboratory Tests............................................................... 108 

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10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting .................................................................... 109 
10.3.1. Definition of AE ..................................................................................... 109 
10.3.2. Definition of SAE .................................................................................. 110 
10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs .................... 112 
10.3.4. Reporting of SAEs ................................................................................. 115 
10.4. Appendix 4: Contraceptive Guidance ................................................................. 117 
10.4.1. Male Participant Reproductive Inclusion Criteria ................................. 117 
10.4.2. Female Participant Reproductive Inclusion Criteria .............................. 117 
10.4.3. Woman of Childbearing Potential .......................................................... 117 
10.4.4. Contraception Methods .......................................................................... 118 
10.5. Appendix 5: Genetics ......................................................................................... 121 
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments ...... 122 
10.7. Appendix 7: ECG Findings of Potential Clinical Concern ................................. 124 
10.8. Appendix 8: Detailed Dose Escalation/De-escalation Scheme for BLRM 
Design ..................................................................................................................... 126 
10.8.1. Statistical Models ................................................................................... 126 
10.8.1.1. Prior Specifications for monotherapy BLRM ....................... 126 
10.9. Appendix 9: CRS Mitigation and Management .................................................. 129 
10.10. Appendix 10: Alternative Measures During Public Emergencies .................... 133 
10.10.1. Eligibility ............................................................................................. 133 
10.10.2. Telehealth Visits .................................................................................. 133 
10.10.3. Alternative Facilities for Safety Assessments ...................................... 133 
10.10.3.1. Laboratory Testing ............................................................. 134 
10.10.3.2. Electrocardiograms ............................................................. 134 
10.10.3.3. Echocardiogram or MUGA ................................................ 134 
10.10.4. Study Intervention ................................................................................ 135 
10.10.5. Adverse Events and Serious Adverse Events ....................................... 135 
10.11. Appendix 11: Response Evaluation Criteria in Solid Tumors (RECIST) 
version 1.1 Guidelines ............................................................................................. 136 
10.12. Appendix 12: Subcutaneous Injection Site Locations ...................................... 141 
10.13. Appendix 13: ECOG Performance Status* ...................................................... 143 
10.14. Appendix 14: Management for Immune-Related Adverse Events .................... 144 

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10.15. Appendix 15: Management of Infusion Related Reactions ............................... 152 
10.16. Appendix 16: Abbreviations .............................................................................. 153 
11. REFERENCES ................................................................................................................. 159 
 
 
 
 
LIST OF TABLES 
Table 1. 
Projected Exposure After SC and IV Dosing ........................................... 50 
Table 2. 
Provisional Dose Levels ........................................................................... 51 
Table 3. 
Available Dose Reduction Levels From Starting Dose ........................... 70 
Table 4. 
Treatment Dose Modifications for Study Intervention-Related 
Toxicity .................................................................................................... 71 
Table 5. 
Posterior Probability that the true ORR (θ) is above or below some 
threshold, for a given observed ORR. ...................................................... 91 
Table 6. 
Safety Laboratory Tests ......................................................................... 108 
Table 7. 
ASTCT CRS Revised Grading System .................................................. 129 
Table 8. 
Definition of High Dose Vasopressor .................................................... 130 

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1. PROTOCOL SUMMARY 
1.1. Synopsis 
Short Title: Phase 1 Study of PF-07209960 in Advanced or Metastatic Solid Tumors 
Rationale 
PF-07209960 is a fusion of a single, potency-reduced, IL-15 mutein and a bivalent high 
affinity anti-PD-1 full length IgG. This antibody-cytokine fusion molecule is designed to 
deliver PD-1-mediated avidity-driven IL-2/15 receptor stimulation preferentially to PD-1- 
positive CD8+ T cells, which are enriched in tumors and can mediate anti-tumor activity, 
while reducing the natural preference of IL-15 for majority PD-1-negative NK cells, which 
may mediate toxicity. The exposure of the IL-15 mutein is extended by fusing it to an 
antibody, which also reduces its potency to prevent systemic activation of PD-1 negative 
lymphocytes. Pre-clinical data suggest the stimulatory activity of PD-1 targeted IL-15 mutein 
is enhanced in tumor infiltrating lymphocytes preferentially over peripheral lymphocytes and 
can lead to anti-tumor activity greater than can be achieved with anti-PD-1 and IL-15 agonist 
either alone or in combination. The purpose of this FIH study is to evaluate the safety, 
tolerability, PK, PD and potential clinical benefits of PF-07209960 in participants with 
selected locally advanced or metastatic solid tumors in dose escalation/finding (Part 1) and 
selected solid tumors in dose expansion at the RP2D (Part 2). In order to explore the activity 
of PF-07209960 beyond tumor types which can be treated with anti-PD-1/PD-L1, these will 
include tumor types resistant to prior anti-PD-1/PD-L1 therapy (NSCLC, SCCHN, RCC, 
UC) and tumor types for which no anti-PD-1/PD-L1 standard of care therapy is available 
(OvCa, MSS CRC). 
Objectives and Endpoints 
 
PART 1 DOSE ESCALATION 
Objectives 
Endpoints 
Primary: 
Primary: 
• 
To assess safety and tolerability at increasing dose 
levels of PF-07209960 in participants with select 
locally advanced/metastatic solid tumors in order to 
estimate the MTD and select the RP2D/schedule. 
• 
First cycle DLTs. 
• 
AEs as characterized by type, frequency, severity (as 
graded by NCI CTCAE version 5.0; for CRS as graded 
by ASTCT criteria), timing, seriousness, and 
relationship to study therapy. 
• 
Laboratory abnormalities as characterized by type, 
frequency, severity (as graded by NCI CTCAE 
version 5.0), and timing. 
Secondary: 
Secondary: 
• 
To characterize the single and multiple dose PK of 
PF-07209960. 
• 
Single dose: Cmax, Tmax, AUCtau. If data permits, 
AUCinf, CL/F, t1/2 ; 
• 
Multiple Dose: Cmax,ss, Tmax,ss, AUCtau,ss. If data permits, 
CLss/F, t1/2,ss, and Rac; 
• 
Ctrough at selected time points; 
• 
To evaluate the immunogenicity of PF-07209960. 
• 
Incidence, titers and endogenous IL-15 cross-reactivity 
of ADA and NAb against PF-07209960; 
• 
To evaluate preliminary anti-tumor activity. 
• 
ORR, DCR as assessed using the RECIST version 1.1. 
• 
Time-to-event endpoints: DOR, PFS, and TTP by 
RECIST version 1.1 

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PART 2 DOSE EXPANSION 
Obiectives 
Endooints 
Primarv: 
P1·imary: 
• 
To confinnsafety and tolerability of 
PF-07209960 at the RP2D in participants with 
selected tumor types. 
• 
To evaluate prelim.ina1y evidence of anti-tumor 
activity of PF-07209960 in pa1ticipants with 
selected tumor types. 
•  AEs as characterized by type, frequency, severity (as 
graded by NCI CTCAE version 5.0; for CRS as graded 
by ASTCT criteria), tiniing, seriousness, and relationship 
to study therapy. 
• 
Laborato1y abnonnalities as chara.cterized by type, 
frequency, severity (as graded by NCI CTCAE 
version 5.0), and timing. 
• 
ORR as detennined by RECIST version I. I. 
Secondary: 
Secondary: 
• 
To fmther evaluate the PK of PF-07209960 at the 
RP2D. 
• 
Single dose: Cmax, Tmax, AUCtau, If data pennits, AUCini, 
CL/F, t½; 
•  Multiple Dose: Cmax,ss, Tmax,ss, AUCtau,ss. If data pemiits, 
CLsJF, h/2,ss, and Rae; 
• 
Ctrough at selected time points. 
• 
To evaluate the immunogenicity of PF-07209960. 
• 
Incidence, titers and endogenous IL-15 cross-reactivity of 
ADA and NAb against PF-07209960. 
• 
To evaluate the effect of PF-07209960 on immune 
cells in tumor biopsies. 
• 
Intra-tumor T cells (such as by CDS IHC) in on-treatment 
versus baseline tumor biopsy samples. 
 
 
 
 
 
 
 
 
 
 
 
 

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PART 2 DOSE EXPANSION 
Ob"ectives 
End oints 
• 
To evaluate prelim.ina1y anti-tumor activity 
through time to event endpoints. 
• 
DCR, DOR, PFS, and TIP by RECIST version 1.1 
• 
To assess overall survival of participants treated 
with PF-07209960. 
• 
Overall survival 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Overall Design 
This is a Phase 1, open label, multicenter, multiple dose, dose escalation, safety, PK and PD 
study of PF-07209960 in paiticipants with selected locally advanced or metastatic solid 
tumors (anti-PD-1/PD-Ll resistant NSCLC, SCCHN, RCC, UC; or anti-PD-I nai:Ve OvCa 
and MSS CRC) for whom no standai·d therapy is available, or would not be an appropriate 
option in the opinion of the paiticipant and their treating physician, or paiticipants who have 
refused standai·d therapy. 
The study contains 2 paits, single agent dose escalation (Pait 1) followed by a dose 
expansion at the RP2D (Pait 2). The overall study design is depicted in the schema 
(Section 1.2). Successive coho1ts of pa1ticipants in Pait 1 will receive escalating doses of 
PF-07209960 as a SC or IV administration eve1y 2 weeks. The first and second paiticipant in 
each dose level must be emolled >72 hours apait. BLRM guided by EWOC principle will be 
used to guide dose escalation process and detennine the MTD/RP2D. Part 1 will estimate the 
MTD/RP2D in sequential dose escalation coho1ts for PF-07209960 as single agent in 
paiticipants with selected solid tumors. After the MTD/RP2D for PF-07209960 single agent 
is detennined, Pait 2 expansion will be initiated in paiticipants with selected solid tumors as 
info1med by Pait 1. 

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Key Inclusion Criteria: 
1. Locally advanced/metastatic NSCLC, SCCHN, RCC, UC, OvCa, or MSS CRC. 
a. At least 1 prior line of therapy for recurrent or metastatic disease, including either 
standards of care or investigational therapies. Participants must have progressed 
or relapsed after or be intolerant to standard therapy approved for the specific 
tumor type. Exception: participants who actively decline available standard of 
care therapies are eligible upon documentation of their refusal. 
b. Participants with NSCLC, SCCHN, RCC, or UC must have received prior 
anti-PD-1/PD-L1 either as monotherapy or in a combination regimen and had 
experienced radiographic progression. 
c. Participants with NSCLC must not have known ALK, ROS1, MET exon 14 
skipping, RET rearrangement or EGFR mutation. 
d. Participants who had received prior anti-PD-1 must be ≥90 days from their last 
anti-PD-1 dose. Participants who received prior anti-PD-L1 are not subject to this 
restriction. 
e. Participants with OvCa or MSS CRC must not have received prior anti-PD-1/PD- 
L1 therapy. 
f. Demonstrated radiographic progression on most recent tumor assessment 
imaging. 
g. For Part 2, in addition: 
a) Participants with NSCLC must have received either ≥2 prior lines of therapy 
including at ≥1 prior regimen containing chemotherapy and ≥1 prior regimen 
containing anti-PD-1/PD-L1 or a prior regimen of anti-PD-1/PD-L1 in 
combination with chemotherapy (eg, atezolizumab with chemotherapy). In 
addition, NSCLC with a BRAF V600E mutation must have also received 
BRAF inhibitor with or without MEK inhibitor. 
b) Participants with RCC must have received either ≥2 prior lines of therapy 
including ≥1 prior regimen containing anti-PD-1/PD-L1 and ≥1 prior regimen 
containing a small molecule kinase inhibitor or a prior regimen of 
anti-PD-1/PD-L1 in combination with a small molecule kinase inhibitor (eg, 
avelumab with axitinib). 
c) Participants with UC must have received ≥2 prior linesof therapy including 
platinum-containing chemotherapy and anti-PD-1/PD-L1, or a single regimen 
of platinum-containing chemotherapy followed by anti-PD-1/PD-L1 
maintenance therapy. 
d) Participants with MSS CRC must have received ≥2 prior lines of therapy 
including treatment regimens containing combinations of pyrimidine analog, 
oxaliplatin, irinotecan, anti-EGFR (RAS wild type), encorafenib (if BRAF 
V600E-positive) and anti-HER2 (if HER2 amplified and RAS and BRAF wild 
type). 

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e)  Participants with OvCa must have received ≥2 prior lines of therapy 
including at least 1 regimen with platinum-based chemotherapy and 
progressed on last two consecutive regimens without evidence of clinical 
benefit. 
2. Participants entering the study in the expansion cohort have ≥1 measurable lesion per 
RECIST version 1.1 that has not been previously irradiated. 
3. Tumor tissue available or accessible for biopsy: 
a. Participants enrolled in Part 1 and Part 2 should consent to undergo biopsy during 
screening (pre-treatment) or be able to provide archival FFPE material containing 
tumor that is of diagnostic quality and representative of their diagnosed 
malignancy taken ≤1 year prior to study start. If the archival sample is older than 
1 year and a biopsy during screening cannot be performed, the investigator must 
contact the sponsor to discuss eligibility prior to enrollment. 
b. Participants enrolled in Part 2 dose expansion must have a tumor amenable to 
biopsy and consent to planned mandatory pre- and on-treatment biopsy 
procedures until the sponsor deems that an adequate number of participants (10- 
15 paired fresh biopsies per cohort) have been successfully biopsied, at which 
point participants will only be required to submit pre-treatment biopsies (either 
archival tissue or de novo biopsy as above). Special considerations will be made 
for participants with poorly-accessible tumors or deemed medically unsafe as 
determined by the investigator after discussion and agreement by the sponsor. 
4. ECOG PS 0-2 for Part 1, 0-1 for Part 2. 
5. Adequate hematologic function. 
6. Adequate renal and liver function. 
7. Adequate coagulation function. 
Key Exclusion Criteria: 
1. Symptomatic brain or leptomeningeal metastases requiring steroids. 
2. Any other active malignancy within 3 years prior to enrollment, except for adequately 
treated basal cell or squamous cell skin cancer, or carcinoma in situ. 
3. Major surgery and/or radiation therapy within 4 weeks prior to planned first dose. 
4. Systemic anti-cancer therapy within 4 weeks prior to planned first dose (6 weeks for 
mitomycin C or nitrosoureas). If the last immediate anti-cancer treatment contained 
an antibody based agent(s) (approved or investigational), then an interval of 28 days 
or 5 half-life (whichever is shorter) of the agent(s) prior to receiving the study 
intervention treatment is required. Participants who received anti-PD-1 (but not anti- 
PD-L1) therapy require an interval of 90 days prior to planned first dose. 
5. Active and clinically significant bacterial, fungal, or viral infection, Hepatitis B or 
Hepatitis C infection at screening (positive HBsAg or positive HCV RNA if 
anti-HCV antibody test positive), known HIV or AIDS-related illness. HIV 

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seropositive participants, who are in good health and at low-risk for AIDS-related 
outcomes, may qualify for inclusion in the study after discussion with the sponsor, 
but AIDS is exclusionary. 
6. Anticoagulation with vitamin K antagonists is not allowed. Anticoagulation with low 
molecular weight heparin and Factor Xa inhibitors or use of antiplatelet therapy is 
allowed but must be held per institutional requirements for biopsies and whenever 
platelet count is <50,000/mm3. If participants are on antiplatelet therapy, they must be 
able to hold antiplatelet therapy for first week of study treatment without significantly 
increased risk of cardiovascular events. 
7. AEs from prior therapy which have not recovered to Grade ≤1 or baseline. 
8. History of Grade ≥3 immune-related AE considered related to prior immune 
modulatory therapy and required immunosuppressive therapy (except endocrine 
irAEs managed by hormone replacement therapy). 
9. Active autoimmune disease that might deteriorate when receiving an 
immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or 
hyperthyroid disease not requiring immunosuppressive treatment are eligible. 
10. Current use of immunosuppressive medication at the time of randomization, 
EXCEPT for the following: a) intranasal, inhaled, topical steroids, or local steroid 
injection (eg, intra-articular injection); b) Systemic corticosteroids at physiologic 
doses ≤10 mg/day of prednisone or equivalent; c) Steroids as premedication for 
hypersensitivity reactions (eg, CT scan premedication). 
11. Active bleeding disorder in the past 6 months prior to planned first dose. 
12. History of interstitial lung disease or pneumonitis. 
13. Pregnancy or breastfeeding. 
Number of Participants 
The total number of participants enrolled to study intervention is estimated to range from 
approximately 74 to 172. 
Part 1 Dose Escalation: 
Approximately 14-22 participants are expected to be enrolled in Part 1 dose escalation. The 
total number of participants will depend on the number of dose levels needed to determine 
the MTD/RP2D and the actual number of participants evaluable for DLT at each dose level. 
In general, each cohort in the dose escalation part will be approximately 2-4 participants. 
DLT observation period is 28 days after C1D1 for all participants. For the dose level that is 
estimated to be the MTD, a minimum of 6 DLT evaluable participants will be treated at this 
dose. 
Part 2: Dose Expansion: 
Each cohort in Part 2 will enroll 20-30 participants. Approximately 60-90 participants will be 
initially enrolled in the first three cohorts, with the option to further enroll approximately 40- 

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60 participants in an additional two cohorts. The Part 2 dose expansion phase will consist of 
approximately 5 cohorts, which will evaluate safety and anti-tumor activity of PF-07209960 
at the RP2D determined in Part 1. Opening of cohorts in Part 2 will initially include tumor 
type(s) and setting(s) deemed more likely to demonstrate anti-tumor activity based on data 
from Part 1. At this time, Part 2 expansion cohorts in NSCLC, RCC and UC have been 
chosen as initial tumor types to study due to their responsiveness to immunotherapy agents. 
If preliminary anti-tumor activity is seen with OvCa and MSS CRC in Part 1 or if anti-tumor 
activity is observed in at least one tumor type out of NSCLC, RCC, and UC in Part 2, the 
optional OvCa and MSS CRC expansion cohorts would be considered for enrollment. Tumor 
indications for Part 2 could also be re-prioritized based on emerging data from Part 1. Sample 
size determination is presented in Section 9.2. 
Intervention Groups and Duration 
PF-07209960 will be administered as monotherapy, SC or IV infusion over 1 hours 
(±10 minutes) on Days 1 and 15 in 28 day cycles as described in Section 4.3.1. Treatment 
with study intervention will continue until either disease progression, unacceptable toxicity, 
participant refusal, or whichever is earliest, unless the investigator and medical monitor agree 
to treatment beyond disease progression based on individual benefit/risk assessments or 
agree to discontinue treatment or the study is terminated. 
The starting dose for PF-07209960 for this FIH study has been determined to be CCI 
 
. The starting dose for IV infusion is described in Section 4.3.1.2. The SC route has the 
potential to reduce the Cmax which is believed to be associated with CRS and inflammatory 
responses, common AEs for agents that stimulate T cells. If excessive ISR or unexpected low 
exposure is encountered with SC dosing, an alternative IV infusion Q2W administration may 
be explored. The IV dose escalation/finding would begin at a starting dose based on the 
available emerging clinical data (including safety/tolerability, PK, PD) from the dose 
escalation cohorts with SC Q2W administration. All participants will be monitored during 
and following their first dose (regardless of SC or IV dosing) with a 72-hour inpatient 
hospitalization period throughout dose escalation. Participants receiving IV dosing on 
C1D15 will remain at the investigational site for observation for at least 8 hours following IV 
infusion. Participants may not be released until the investigator has confirmed the participant 
has not exhibited signs and symptoms of a cytokine reaction. For additional information, 
refer to Section 4.3.1. Dose modification information is provided in Section 6.6. 
A participant is considered to have completed the study if he/she has completed all phases of 
the study including the end of treatment visit. 
The end of the study will be the date of the last visit of the last participants or 2 years after 
the last participant receives their first dose (whichever occurs first). The study may also be 
terminated at any time at the discretion of the sponsor. Any additional treatment beyond 
2 years shall be discussed and approved by the sponsor. 
Statistical Methods 
There is no formal hypothesis testing in this study. 

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Unless otherwise specified, summaries will be presented by dose group and overall. 
Descriptive statistics, such as the mean, standard deviation, coefficient of variation, median, 
minimum, and maximum values, will be provided for continuous endpoints. The rates of 
binary endpoints will be provided along with the corresponding 2-sided 95% confidence 
intervals using an exact method. Time-to-event endpoints will be summarized using the 
Kaplan-Meier method and displayed graphically when appropriate. Median event times and 
2-sided 95% confidence intervals for each time-to-event endpoint will be provided. 
 
The dose escalation in the Part 1 of the study will be guided by a Bayesian analysis of DLT 
data for PF-07209960. Dose toxicity is modelled using two-parameter logistic regression for 
the probability of a participant experiencing a DLT at the given dose. 
After each cohort of participants, the posterior distribution for the risk of DLT for new 
participants at different doses of interest for PF-07209960 will be evaluated. The posterior 
distributions will be summarized to provide the posterior probability that the risk of DLT lies 
within the following intervals: 
 
 
Under-dosing 
[0, 0.16] 
Targeted dosing 
[0.16, 0.33] 
Overdosing 
[0.33, 1] 
 
Dosing decisions are guided by the escalation with overdose control (Rogatko et al, 2007). A 
dose may only be used for newly enrolled participants if the probability of overdosing at that 
dose is CCI 
. 
Recommendation from the BLRM, along with safety (AEs, SAEs), laboratory, PK, 
biomarker and other relevant data, will be used at the time of each dose escalation and for 
MTD/RP2D determination. 

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:, ----------------------------------------------- , 
►
: 
PDx Nai:ve MSS CRC based on 
I 
1.2. Schema 
 
Dose Escalation 
Dose Expansion 
 
 
Single agent BLRM dose escalation in solid tumors: 
anti-PDl/PD-Ll resistant- NSCLC, SCCHN, RCC, 
UC; anti-PD-I nai:Ve-OvCa and MSS CRC 
Tumor specific monotherapy dose expansion 
Mandatory, de novo, pre- and on-treatment 
(C2Dl) biopsies required in 10-15 pa1ticipants 
 
 
Part 11 Single Agent 
Part 2I Sine:le Ae:ent  
 
Cohort 1 
 
 
♦ 
I 
f ---- t 
 
 
 
 
I 
I 
I 
I L 
 
 
 
 
 
 
 
 
 
 
PDx Nai:ve OvCa based on evolving 
I 
 
 
Cohort 2 
 
 
 
Cohort3 
 
 
 
Cohort 4b 
I -  -  -  -  -  -►1 
data (n=20-30) 
I 
 
 
 
a. Refer to Table 2 for provisional dose levels. 
I 
L ------------ 
I 
I  
 ௭ ------------------- --. 
I 
evolving data (n=20-30) 
I 
1 -------------------------------------- I 
Cohort 5b 
b. Coho1ts 4 and 5 to be considered for activation only after early signs of efficacy are seen in Coho1ts 1, 2 
and/or 3. 
Dose level 1• 
n=2-4 
Dose level 2• 
n=2-4 
 
 
Dose level 3• 
n=2-4 
Single agent: MTD/RP2D 
n 6 
PDx resistant NSCLC 
monotherapy (n=20-30) 
-
PDx resistant RCC 
monotherapy (n=20-30) 
-
PDx resistant UC 
monotherapy (n=20-30) 

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PFIZER CONFIDENTIAL 
Page 21 
 
 
 
1.3. Schedule of Activities 
The SoA table provides an overview of the protocol visits and procedures. Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section of the protocol for detailed infonnation on each assessment required for compliance with the protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the paiiicipant. 
 
Screening 
Cycle 1(28 days)-A 
Cycle 2(28 days) - B 
Cvcle >3(28 days) - C 
Notes 
Days 
Up to 28 days 
prior to ClDl 
1 
A 
1 
B/C 
2 
A 
3 
A 
4 
A 
8 
A 
15 
A/B/C 
16 
B 
17 
B 
18 
B 
22 
A/B 
Visit Window 
-72 
h1·s ±2 
davs ±4 
hrs 
±4 
h.-s 
±4 
hrs 
±1 
day 
±2 
davs 
±4 
h.-s ±4 
h1·s 
±24 
h.-s 
±24 
hrs 
Informed consent 
and registration 
A 
A 
•  Info,med consent must be obtained 
prior to undergoing any 
study-specific procedures. 
• Participant enrollment number and 
dose level allocation assigned by 
Pfizer Inc. 
Medical History 
A 
• Includes tumor history and other 
medical history. 
Phvsical Examination 
Complete Physical 
Exam 
A 
A 
• Include height only at screen (not 
needed at ClDl). 
• Include weie.ht at screenine.. 
Brief Physical Exam 
BIC 
A 
A 
A 
A 
AIBIC 
AIB 
• Include weight D1 of each cycle 
only. 
• Height not needed. 
• Daily while hospitalized. 
ECOG Pe,fonuance 
Status 
A 
A 
BIC 
AIBIC 
Vital Signs 
A 
A 
BIC 
A 
A 
A 
A 
AIBIC 
• Meastu·e vitals prior to the 
PF-07209960 treatment. 

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Page 22 
 
 
 
 
Screening 
Cycle 1(28 days)-A 
Cycle 2(28 days) - B 
Cvcle >3(28 days) - C 
Notes 
Days 
Up to 28 days 
prior to ClDl 
1 
A 
1 
B/C 
2 
A 
3 
A 
4 
A 
8 
A 
15 
A/B/C 
16 
B 
17 
B 
18 
B 
22 
A/B 
Visit Window 
-72 
h1·s ±2 
davs ±4 
hrs 
±4 
h.-s 
±4 
hrs 
±1 
day 
±2 
davs 
±4 
h.-s 
±4 
h1·s 
±24 
h.-s 
±24 
hrs 
• In addition, temperature (oral 
prefen-ed), HR, BP, will be collected 
eve,y 6 hotu·s and as needed dtuing 
initial 72-hom·inpatient monito,ine.. 
Electrocardiogram 
A 
A 
BIC 
A 
A 
AIB 
B 
•  Pe1fo1m 3 consecutive 12-lead ECGs 
approximately 1-4 minutes apa,t to 
dete1mine mean QTcF interval. 
Additional triplicate ECGs may be 
pe1fo1med as clinically indicated. 
•  Pe1fo1m ECGs before blood draw; 
plan the timing of ECG such that PK 
collection afte,wards can be around 
the intended time. 
•  Additional ECG monito,ing if a) the 
mean value from the triplicate 
measm·ements for any postdose 
QTcF interval is increased by 
:C:::60 msec from the baseline and is 
>450 msec; orb) an absolute QTcF 
value is >500 msec for any scheduled 
ECG.) Consultation with a 
cardiologist will be performed if 
clinically waffanted or if the QTcF 
value is >500 msec for any scheduled 
ECG. 
• If treatment is :C::3 cycles, last 
electrocardiogram is done C3Dl. 
Echocardiogram or 
MUGA 
A 
A 
•  MUGA preferred over 
echocardiogram; iniaging method 
must be consistent throughout the 
studv for individual participants. 

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Screening 
Cycle 1(28 days)-A 
Cycle 2(28 days) - B 
Cvcle >3(28 days) - C 
Notes 
Days 
Up to 28 days 
prior to ClDl 
1 
A 
1 
B/C 
2 
A 
3 
A 
4 
A 
8 
A 
15 
A/B/C 
16 
B 
17 
B 
18 
B 
22 
A/B 
Visit Window 
-72 
h1·s ±2 
davs ±4 
hrs 
±4 
h.-s 
±4 
hrs 
±1 
day 
±2 
davs 
±4 
h.-s 
±4 
h1·s 
±24 
h.-s 
±24 
hrs 
•  Assess at baseline. Additional testing 
as clinically indicated. 
Blood Draw for Laboratory Assessments 
•  All blood draws for laboratory 
assessment can be done at the first 
draw for PK/ADA/immunogenicity 
as per Section 8.9. 
• No need to repeat on ClDl if 
baseline assessment performed 
within 72 hrs prior to ClDl. 
• ClDl onwards: perform assessments 
within 48 hours prior to dosing. 
• Samples will be analyzed locally. 
• Refer to Appendix 2 for additional 
information. 
Hematology 
A 
A 
B/C 
A 
A 
A 
A 
A/BIC 
A 
Blood Chemistry 
A 
A 
B/C 
A 
A 
A 
A 
A/BIC 
A 
• CRP and fen-itin measurement not 
required after C2Dl if within nonual 
range or similar to baseline levels; 
however, CRP and fenitin should 
be measured anytime CRS is 
suspected and not already 
scheduled to be measured (eg, 
Cycle 2). 
Coagulation 
A 
A 
B/C 
A 
A 
A 
A 
A/BIC 
A 
• PT/INR and PTI/aPTI, 
• TT, fibrinogen, D-dimer for Cycle 1 
and as clinically indicated. 
Thyroid Test 
A 
A 
C 
(Q12 
W) 
• TSH, free T4 
•  Assess eve1y 3 cycles after 3 
cycles. 

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PFIZER CONFIDENTIAL 
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Screening 
Cycle 1 (28 days)-A 
Cycle 2 (28 days) - B 
C cle3 28 days - C 
Notes 
Days 
Up to 28 days 
prior to ClDl 
1 
A 
1 
B/C 
2 
A 
3 
A 
4 
A 
8 
A 
15 
A/B/C 
16 
B 
17 
B 
18 
B 
22 
A/B 
Visit Window 
-72 
±2 
±4 
±4 
±4 
±1 
±2 
±4 
±4 
±24 
±24 
 
 
 
 
 
 
 
 
 
Hepatitis Serology 
A 
A 
• Serology (HBsAg, anti-HCV 
antibody) 
• If anti-HCV antibody test is positive, 
HCV RNA test must be pe1fon11ed 
Tumol' Mal'kel's 
 
 
 
Pl'egnancy Testing 
A 
A 
B/C 
Ul'inalysis 
A 
A 
B/C 
AIBIC 
•  No need to repeat on ClDl if 
baseline assessment pe1fo1med 
within 7 days prior to ClDl. 
•  Dipstick is acceptable at minimum at 
screening and end of treatment visit. 
• Samples will be analyzed locally. 
Pharmacokinetics Assessments 
PK Blood [semm] 
Sampling for 
PF-07209960 
Schedule of Activities: Phanuacokinetic, Blood Phanuac,odynamic, 
Immunophenotyping, and Cytokine Activity 

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PFIZER CONFIDENTIAL 
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Days 
Screening 
Up to 28 days 
1 
prior to ClDl 
A 
Cycle 1(28 days)-A 
Cycle 2(28 days) - B 
C cle3 28 days - C 
Notes 
Visit Window 
-72 ±2 ±4 ±4 ±4  ±1 
±2  ±4 ±4 ±24 ±24 
h1·s 
da s 
hrs 
h.-s 
hrs 
day 
da s 
h.-s 
h1·s 
h.-s 
hrs 
Anti-PF-07209960 
Antibodies (ADA and 
NAb) Blood Samples 
(semm) 
Schedule of Activities: Phannacokinetic, Blood Phannac,odynamic, 
Immunophenotyping, and Cytokine Activity 
Pharmacodynamic_A,s..s._e_ss_m_e_n_ts  ..... 
""T'" ------------------------------------------- 1 
Schedule of Activities: Phannacokinetic, Blood Phannac,odynamic, 
Immunophenotyping, and Cytokine Activity 
Schedule of Activities: Phannacokinetic, Blood Phannac,odynamic, 
Immunophenotyping, and Cytokine Activity 
Schedule of Activities: Phannacokinetic, Blood Phannac,odynamic, 
Immunophenotyping, and Cytokine Activity 
Schedule of Activities: Phannacokinetic, Blood Phannac,odynamic, 
Immunophenotyping, and Cytokine Activity 
Treatment 
PF-07209960 
Administration 
A 
BIC 
A!BIC 
•  Participants should remain at the 
investigational site for observation 
for at least 1-hotu·post dose for all 
treatment visits after ClDl. For 
ClD15 PF-07209960 IV 
administration, participants should 
remain at the investigational site for 
observation for at least 8-hotu-spost 
dose. See requirements for ClDl 
under Inpatient Monitoring. Actual 
observation times for Cycle 2 and 
beyond may be adjusted per 
investigator's medical judgement, 
depending on clinical experience 
with revious doses. 
1 
2 
3 
4 
8 
15 
16 
17 
18 
22 
B/C 
A 
A 
A 
A 
A/B/C 
B 
B 
B 
A/B 

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Screening 
Cycle 1(28 days)-A 
Cycle 2(28 days) - B 
Cvcle >3(28 days) - C 
Notes 
Days 
Up to 28 days 
prior to ClDl 
1 
A 
1 
B/C 
2 
A 
3 
A 
4 
A 
8 
A 
15 
A/B/C 
16 
B 
17 
B 
18 
B 
22 
A/B 
Visit Window 
-72 
h1·s ±2 
davs ±4 
hrs 
±4 
h.-s 
±4 
hrs 
±1 
day 
±2 
davs 
±4 
h.-s 
±4 
h1·s 
±24 
h.-s 
±24 
hrs 
• Observation periods will be re- 
evaluated prior to Patt 2 statt based 
on Patt 1 experience. 
•  If CRS occurs, participants may be 
released only after the investigator 
has confomed the patticipant has 
sufficiently recovered from CRS. 
•  Participants should complete the 
required study specific laboratory 
assessments as detailed in 
Aooendix 2. 
Inpatient Monitoring 
(Hospitalization) 
A 
A 
A 
A 
•  Participants will be admitted for 
inpatient monitoring (per local 
standard of practice) dtuing and 
following their first dose for at least 
72 hotu·s following the first 
administration of study treatment 
(ClDl). 
•  Hospitalization period may be 
extended if the participant 
experiences abnonual laboratory 
findings or ongoing AEs that require 
further hospitalization. 
Local Injection Site 
Tolerability 
Assessment (SC 
only) 
A 
BIC 
A 
A 
A 
A!BIC 
• To be petfonued for SC injection 
only. 
•  Assess injection site tolerability for 
at least 1 hotu·following treatment 
administration in Cycle 1. 
•  Perform daily during hospitalization 
for first dose or until no skin changes 
are seen at injection site, whichever 
comes first. 

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Screening 
Cycle 1(28 days)-A 
Cycle 2(28 days) - B 
Cvcle >3(28 days) - C 
Notes 
Days 
Up to 28 days 
prior to ClDl 
1 
A 
1 
B/C 
2 
A 
3 
A 
4 
A 
8 
A 
15 
A/B/C 
16 
B 
17 
B 
18 
B 
22 
A/B 
Visit Window 
-72 
h1·s ±2 
davs ±4 
hrs 
±4 
h.-s 
±4 
hrs 
±1 
day 
±2 
davs 
±4 
h.-s 
±4 
h1·s 
±24 
h.-s 
±24 
hrs 
•  If injection site pain or ISR 
chara.cteristics continue to persist 
after the first cycle, local site 
injection tolerability assessments 
should continue until the symptoms 
resolve. 
Tumor Response Assessment 
CT or MRI scans of 
chest, abdomen, 
pelvis, any clinically 
indicated sites of 
disease, and of bone 
lesions; clinical 
evaluation of 
superficial disease 
A 
Pe1fon11ed eve1y 8 weeks from ClDl (±7 days) for the first 6 months, and then 
eveiy 12 weeks (±7 days) thereafter. 
• Refer to Appendix 11 
• If allergic to contrast agents for 
imaging, a non-contrast computed 
tomography of the chest with 
contrast enhanced abdominal and 
pelvic MRI can be used. 
•  Brain scans and/or bone scans to be 
pe1formed at baseline if disease is 
suspected and during study as 
appropriate to follow disease. 
Adverse Event 
Assessments 
A 
BIC 
A 
A 
A 
A 
A!BIC 
B 
B 
B 
AIB 
• Document AEs using the NCI 
CTCAE version 5 as described in 
Appendix 3. 
• If the participant begins a new 
anticancer therapy, refer to 
Section 8.3.1 for guidance on the 
recording of AEs on CRF. 
Concomitant 
Treatment(s) 
A 
BIC 
A 
A 
A 
A 
A!BIC 
B 
B 
B 
AIB 
• All concomitant treatment and Non 
Dmg Supportive Interventions should 
be recorded on the CRF. 
Tissue Sampling 

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Screening 
Cycle 1(28 days)-A 
Cycle 2(28 days) - B 
Cvcle >3(28 days) - C 
Notes 
Days 
Up to 28 days 
prior to ClDl 
1 
A 
1 
B/C 
2 
A 
3 
A 
4 
A 
8 
A 
15 
A/B/C 
16 
B 
17 
B 
18 
B 
22 
A/B 
Visit Window 
-72 
h1·s ±2 
davs ±4 
hrs 
±4
h.-s 
±4 
hrs 
±1 
day 
±2 
davs 
±4 
h.-s 
±4
h1·s 
±24 
h.-s ±24 
hrs 
Archival Tumor Tissue 
(Mandatory for both 
Part 1 Dose Escalation 
and Pait 2 Dose 
Expansion) 
A 
•  An archival sample collected ::;I year 
prior to study stait should be 
submitted per laboratoiy manual. 
• If archival FFPE ::;I year is not 
available a fresh tumor sample must 
be collected at screening (see next 
row). 
•  If the archival sample is older than 1 
year and a biopsy dtuing screening 
cannot be peifoimed, the investigator 
must contact the sponsor to discuss 
elillibilitv orior to enrolhuent. 
De Novo (Fresh) 
Tumor Biopsies 
(Optional for Part 1 
Dose Escalation; 
Mandatory in Part 2 
Dose Expansion with 
approxiniately10-15 
Pre- and On-Treatment 
Paired Biopsies per 
Cohort) 
A 
B 
• Optional (but highlyencom·aged) on- 
treatment fresh tumor biopsies at 
C2D1 in Part 1 dose escalation. 
•  Paiticipants in Pait 1 who provide 
fresh on-treatment tumor biopsies 
should also provide fresh pre- 
treatment ttuuor biopsies as paired 
samples. 
•  Part.2 dose expansion: mandatoiy 
fresh pre- and on-treatment tumor 
biopsy pairs must be collected from 
approximately 10-15 paiticipants at 
baseline and C2Dl (±5 days). 
•  An archival sample collected prior to 
study stait may not be substituted for 
the mandatoiy pre-treatment paired 
biopsy in Part 2 dose expansion. 
• Paiticipants who provide fresh pre- 
and on-treatment tumor biopsy pairs 
could also orovide archival samples. 

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Screening 
Cycle 1(28 days)-A 
Cycle 2(28 days) - B 
Cvcle >3(28 days) - C 
Notes 
Days 
Up to 28 days 
prior to ClDl 
1 
A 
1 
B/C 
2 
A 
3 
A 
4 
A 
8 
A 
15 
A/B/C 
16 
B 
17 
B 
18 
B 
22 
A/B 
Visit Window 
-72 
h1·s ±2 
davs ±4 
hrs 
±4 
h.-s 
±4 
hrs 
±1 
day 
±2 
davs 
±4 
h.-s 
±4 
h1·s 
±24 
h.-s 
±24 
hrs 
•  For additional infonnation refer to 
Se.ction 8.8.1 and the laboratory 
manual. 
Banked Biospecimen 
A 
•  A blood sample (Prep D1) will be 
collected at the screening to be 
retained for potential 
pha1macogenomic/biomarker 
analyses related to dmg response and 
cancer, unless prohibited by local 
regulations or IRB or ethics 
committee decision. 
• If not collected on the designated 
collection day, collect at the next 
available time point when 
biospecimens are being collected in 
coniunction with a participant visit. 

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1.3.1. Schedule of Activities: Pharmacokinetic, Blood Pharmacodynamic, Immunophenotyping, and Cytokine Activity 
 
Cycle 1 (28 days)-A 
Cycle 2 (28 days)- B 
Cycle >3 (28 davs)- C 
NOTES 
Study Day 
1 
2 
3 
4 
8 
15 
16 
17 
18 
22 
Hom·s Pre/Post Dose 
Pre 
EOI 
1 hr 
4 
hrs 
8 
lu·s 
24 
hrs 
48 
lu·s 
72 
hrs 
168 
hrs 
Pre EOI 
llu· 
4hrs 8 
lu·s 
24 
hrs 
48 
lu·s 
72 
hrs 
168 
lu·s 
Visit Window 
<6 
hrs 
±6 
mins 
±30 
min 
s 
±1 
In· 
±4 
hrs 
±8 
lu·s 
±24 
hrs 
±24 
hrs 
<6 
hrs 
±6 
mins 
±30 
mins 
±2 
lu·s 
±4 
hrs 
±4 
lu·s 
±24 
hrs 
±24 
lu·s 
PK Blood [senun] 
Sampling for 
PF-07209960 
A/Bl 
C* 
A 
(IV 
only) 
A 
A 
A 
A 
A 
A 
AIB 
B 
(IV 
only)
B 
B 
B 
B 
B 
B 
•  Predose PK should be collected before SC 
injection or IV infusion. 
•  End of Infusion (EOI) sample timepoints is only 
applicable for IV infusion samples. End of infusion 
PK samples should be taken +I- 10% of the 
infusion duration length (ie within +I- 6 minutes of 
the stop time of a 60-minute infusion from the 
contra-lateral arm of IV infusion; the infusion 
duration includes the flush dm·ation if 
implemented). 
• SC injection: PK Sampling times indicated are 
related to the end of the SC injection. 
• IV infusion: PK sampling times indicated are 
related to the start of the IV infusion. 
•  All efforts should be made to obtain the PK 
samples at the exact nominal time relative to 
dosing. However, samples obtained within the 
window specified will be considered acceptable. 
•  *Start.ing from Cycle 3, pre-dose PK samples will 
be collected on day 1 of eve1y cycle, from Cycle 9, 
on day 1 of eve1y 3rd cycle (C9Dl, C12Dl, ClSDl, 
etc). 
• Additional PK/PD and cytokine samples should 
also be taken inunediately if CRS is suspected, and 
PK/PD samples are not already scheduled to be 
taken. 
Anti-PF-07209960 
Antibodies (ADA and 
NAb) blood samples 
(senun) 
A/Bl 
C* 
A 
• *Starting from Cycle 3, pre-dose anti- 
PF-07209960 samples will be collected on day 1 of 
eve1y cycle, and from Cycle 9, on day 1 of every 
3rd cvcle (C9Dl, C12Dl, ClSDl, etc). 

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Cycle 1 (28 days) -A 
Cycle 2 (28 days)- B 
Cycle 3  28 da 'S - C 
NOTES 
Study Day 
1 
EOI 
1 hr 
±6 
mins 
4 
8 
hrs 
lu·s 
±30  ±1 
min In· 
s 
2 
3 
4 
8 
15 
16 
17 
18 
22 
Hom·s Pre/Post Dose 
Pre 
24 
hrs 
48 
lu·s 
72 
hrs 
168 
hrs 
Pre 
EOI 
llu· 
4 hrs 8 
lu·s 
24 
hrs 
48 
lu·s 
72 
hrs 
168 
lu·s 
Visit Window 
<6 
hrs 
±4 
hrs 
±8 
lu·s 
± 24 
hrs 
± 24 
hrs 
<6 
hrs 
± 6 
mins 
± 30 
mins 
±2 
lu·s 
±4 
hrs 
±4 
lu·s 
±24 
hrs 
±24 
lu·s 
• Predose Anti-PF-072009960 antibodies samples 
should be collected before SC injection or IV 
infusion. 
 
 
 
 
 
 
 
Blood for T Cell 
Immunophenotyping 
AIC 
A 
A 
A 
A 
A 
AIB 
B 
B 
B 
B 
B 
• If treatment is c::3 cycles, last sample is collected at 
C3Dl 
• Refer to Se-ction 8.8.2 for additional infonuation. 
Detailed anel will be included in the lab manual. 
Blood for Gemiline 
A 
 

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1.3.2. Schedule of Activities: End of Treatment, Post-Treatment, and Survival Follow-up 
 
End of 
Treatment1/ 
Withdrawal 
1-Month Follow- 
up2 
Sunival Follow-up3 
Notes 
F01· detailed notes refer· to main schedule of assessment 
28 days after last 
dose 
Every 2 months after 28 days 
Follow-u 
Visit Window (days) 
±7 days 
± 7 days 
E 
lS 
X 
• Assessment ofLVEF using Echocardiogram or MUGA will 
be e1fo1med. 
Blood draw for Laboratory 
A5sessment 
 
 
 
 
 
 
 
 
 
 
CT or MRI scans of chest, 
abdomen, pelvis, any clinically 
indicated sites of disease, and 
ofbone lesions; clinical 
evaluation of superficial 
disease 
X 
X 
• Tumor assessment should be repeated at the end of treatment 
visit if more than 6 weeks have passed since the last 
evaluation. 
• After EOT, continue to repo1t SOC imaging until sta1t of new 
therapy or EOS. 

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End of 
Treatment1/ 
Withdrawal 
1-Month Follow- 
up•- 
Sunival Follow-up3 
Notes 
F01· detailed notes refer to main schedule of assessment 
28 days after· last 
dose 
Every 2 months after· 28 days 
Follow-up 
Visit Window (davs) 
±7 days 
± 7 days 
Subsequent anti-cancer therapy 
X 
X 
• Concomitant treatment(s) and non-drug suppo,tive 
interventions should be recorded on CRF through the End of 
Treatment/Withdrawal Visit should be recorded on the CRF 
for that visit. Only subsequent anti-cancer therapy initiated 
after End of Treatment/Withdrawal Visit will be repo,ted at 
the Follow-up visits. 
Adverse Event Assessment 
X 
X 
X 
•  All AEs and SAEs must be collected until a minimum of 90 
days after the last administration of the study intervention due 
to possible late onset of AE/SAE. 
• The SAEs identified dtuing long-term follow-up will be 
reported to Pfizer Safety on the CT SAE Repo,t Form only if 
considered reasonablv related to the studv intervention. 
PK Blood [sernm) Sampling for 
PF-07209960 
X 
X 
(if suspected ADA- 
relatedAE) 
X 
(if suspected ADA-related AE) 
•  If unresolved AE is considered by the investigator as possibly 
related to or associated with ADA fonuation, the participant 
will be asked to rettun for drug concentration and ADA blood 
sampling at up to 3-month intervals (if feasible given the 
underlying disease), until the AE or its sequelae returns to 
baseline or stabilize at a level acceptable to the investigator 
and snonsor until the last follow-un of the AE. 
Blood Samples for 
Anti-PF-07209960 antibodies 
(ADA and NAb) 
X 
X 
(if suspected ADA- 
relatedAE) 
X 
(if suspected ADA-related AE) 
•  If unresolved AE is considered by the investigator as possibly 
related to or associated with ADA fonuation, the participant 
will be asked to rettun for drug concentration and ADA blood 
sampling at up to 3-month intervals (if feasible given the 
underlying disease), until the AE or its sequelae returns to 
baseline or stabilize at a level acceptable to the investigator 
and snonsor until the last follow-un of the AE. 

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End of 
Treatment1/ 
Withdrawal 
1-Month Follow- 
up•- 
Sunival Follow-up3 
Notes 
F01· detailed notes refer to main schedule of assessment 
28 days after· last 
dose 
Every 2 months after· 28 days 
Follow-up 
Visit Window (days) 
±7 days 
± 7 days 
I. 
End of Treatment/Withdrawal: Visit to be performed as soon as possible but no later than 28 days from the last dose of study intervention and prior to initiation of any 
new anticancer therapy. Obtain these assessments if not completed in the last week (last 6 weeks for tumor assessments). AEs/SAEs collected until a minimum of90 days 
after the last dose of study intervention due to possible late onset of AE/SAE. 
2. 
 1-Month Follow-up: At least 28 calendar days, and no more than 35 calendar days, after discontinuation of study intervention, participants will reb.un to tmdergo review 
of concomitant treatments, vital signs, and assessment for resolution of any treatment-related AEs. AEs/SAEs collected tmtil a mininuuu of 90 days after the last dose of 
study intervention due to possible late onset of AE/SAE. 
3. 
 Survival Follow-up: Subsequent to the 1-month follow-up visit, pa1ticipants survival status will be collected by telephone every 8 weeks (±7 days) to obtain information 
on subsequent anticancer treatment and overall survival tmtil the end of the study. If the participant is seen in the clinic during the window of time that a scheduled 
telephone call is to be made to collect survival data, then the clinic visit ma r lace the survival telephone call. Any standard of care (SOC) b.uuor response assessments 
including CT/MRI imaging and 
obtained between EOT and subsequent anti-cancer therapy w'ill also be collected. 

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2. INTRODUCTION 
PF-07209960, a fusion of a single, potency-reduced, IL-15 mutein and a bivalent high 
affinity anti-PD-1 full length IgG. This antibody-cytokine fusion molecule is designed to 
deliver PD-1-mediated avidity-driven IL-2/15 receptor stimulation preferentially to PD-1- 
positive CD8+ T cells, which are enriched in tumors and can mediate anti-tumor activity, 
while reducing the natural preference of IL-15 for majority PD-1-negative NK cells, which 
may mediate toxicity. The exposure of the IL-15 mutein is extended by fusing it to an 
antibody, which also reduces its potency to prevent systemic activation of PD-1 negative 
lymphocytes. 
2.1. Study Rationale 
Pre-clinical data suggest the stimulatory activity of PD-1 targeted IL-15 mutein is enhanced 
in CD8+ TILs preferentially over peripheral lymphocytes and can lead to anti-tumor activity 
greater than can be achieved with anti-PD-1 and IL-15 agonist either alone or in 
combination, even in immunologically cold tumors that are not typically responsive to anti- 
PD-1 therapy. Moreover, PF-07209960 was shown to stimulate proliferation of CRC PD-1+ 
CD8+ TILs preferentially over other lymphocytes suggesting there may be a potential for 
activity even in a tumor type considered traditionally resistant to immune-based therapies. 
The purpose of this FIH study is to evaluate the safety, tolerability, PK, PD and potential 
clinical benefits of PF-07209960 in participants with selected locally advanced or metastatic 
solid tumors for whom no standard therapy is available in dose escalation/finding (Part 1) 
and selected solid tumors in dose expansion at the RP2D (Part 2). In order to explore the 
activity of PF-07209960 beyond tumor types that can be treated with anti-PD-1/PD-L1, these 
will include tumor types resistant to prior anti-PD-1/PD-L1 therapy (NSCLC, SCCHN, RCC, 
UC) and tumor types for which no anti-PD-1/PD-L1 standard of care therapy is available 
(OvCa, MSS CRC). 
2.2. Background 
In order to optimally activate intra-tumoral CD8+ T cells that are enriched for the inhibitory 
marker PD-1, an anti-PD-1 antibody-IL-15 cytokine fusion approach was developed. This 
antibody-cytokine fusion molecule is designed to have decreased affinity for the IL-2/15 
receptor in order to prevent systemic activation of NK cells and other PD-1-negative 
lymphocytes before reaching PD-1-expressing T cells. Differences in peripheral versus 
intratumoral activation of PD-1 expressing T cells could allow systemically administered 
PF-07209960 to reach levels required for tumor specific T cell proliferation and cytotoxicity 
in participants that may not necessarily lead to systemic toxicity. 
PD-1, an immune checkpoint expressed primarily on T cells that inhibits their activation, has 
emerged as an attractive target for cancer therapy. PD-1 expression is enriched particularly in 
tumor-specific T cells (Gros et al, 2014; Topalian et al, 2015). Antibodies that block PD-1 or 
its ligand PD-L1 and activate these anti-tumor Tcells- are approved in multiple cancer 
indications as standard of care (BAVENCIO (avelumab), 2020; IMFINZI (durvalumab), 
2020; KEYTRUDA (pembrolizumab), 2020; OPDIVO (nivolumab), 2020; TECENTRIQ 

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(atezolizumab), 2020). As the majority of patients with various tumor types treated with 
anti-PD-1/PD-L1 do not respond to treatment, there is a large unmet need to improve upon 
these therapies. 
 
IL-15 and a related cytokine, IL-2, both bind to IL-15 receptors (IL-2Rβ/γ) to induce immune 
cell proliferation and survival, and enhance cytotoxic and cytokine-secreting effector 
functions of lymphocytes such as NK cells and CD8+, CD4+, gamma delta, and NK T cells 
(Waldmann, 1991; Marks-Konczalik et al, 2000; Fehniger & Caligiuri, 2001; Waldmann et 
al, 2001; Waldmann, 2006; Dubois et al, 2017). IL-15 and IL-2 differ in specifically binding 
to IL-15Rα or IL-2Rα, respectively (Waldmann, 2015). IL-15Rα and IL-2Rα are cytokine 
specific and stabilize binding but lack signaling activity (Giri et al, 1995; Liao et al, 2011; 
Ring et al, 2012). As the signal-initiating kinases Jak1 and Jak3 and transcription factor 
pSTAT5 are activated by the receptors for β and γ subunits, it is no surprise that the function 
of IL2 and IL-15 overlap (Waldmann, 2006; PROLEUKIN (aldesleukin), 2019). However, 
due to the differences in α subunit binding, IL-2 uniquely functions to maintain T reg cells 
and participates in activation induced cell death while IL-15 maintains NK cells and CD8+ 
memory T cells (Conlon et al, 2015; Waldmann, 2015). 
 
IL-2 (aldesleukin) is approved for use in metastatic RCC and melanoma (PROLEUKIN 
(aldesleukin), 2019), but its use in the clinic at the prescribed dose required for anti-tumor 
activity has been limited due to short half-life and the primary toxicity of capillary leak 
syndrome associated with systemic immune activation, which requires intensive inpatient 
monitoring and management during administration and restricts treatment to only those with 
the best performance status. Recombinant human IL-15 has also been evaluated in a clinical 
trial, but dose limiting toxicities of grade 3 hypotension, thrombocytopenia and transaminase 
elevations stopped dose escalation without any objective responses observed (Conlon et al, 
2015). Approaches to improve upon IL-2/15 efficacy, pharmacokinetics and toxicity through 
reduced binding to IL-2Rα are currently under evaluation in clinical trials ((Milla et al, 2019; 
Sharma et al, 2020) as are strategies to target IL-2 to tumors through fusion proteins ((Klein 
et al, 2017; Soerensen et al, 2018; Klein et al, 2019). 
 
Combinations with anti-PD-1 antibodies and IL2/15-based molecules are currently under 
investigation in clinical trials and have shown promising anti-tumor activity beyond the 
efficacy observed with these therapies as monotherapies, and in some participants who were 
not expected to respond to anti-PD-1 or relapsed/refractory to it (Wrangle et al, 2018; 
Sharma et al, 2020). This suggests that resistance mechanisms to anti-PD-1/PD-L1 might be 
potentially overcome by cytokines. 
 
The preferential stimulation and resulting uptake of IL-2/IL-15 therapeutic agents by the 
peripheral blood NK cells may limit ability to deliver sufficient exposure in the tumor 
required to activate intratumoral CD8+ T cells (Conlon et al, 2015; Miller et al, 2018). This 
is important as intratumoral CD8+ T cells have been associated with efficacy both in animal 
models and in the clinic (Eyles et al, 2010; Schiavoni et al, 2013). On the other hand, 
activation of NK cells was shown to mediate toxicity in animal models, and likely in humans, 
based on the similarities in toxicities observed in the clinic and in animals (Guo et al, 2015). 

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, was observed following incubation ofhepatocellular carcinoma patient-derived cells 
PF-07209960. 
2.2.1. Nonclinical Pharmacology 
In vitro, PF-07209960 exhibited similar affinity towards human and cynomolgus monkey 
PD-1 antigen and IL-15 c okine rece tors. PF-07209960 bound with hi h affini 
to human 
 
 
 
In vivo, a mouse sunogate of PF-07209960 was utilized due to a lack of binding of 
 
administration of 
(a mouse tumor cell line 
with poor immunogenicity [dowmegulation of MHC-I, tumor antigens and T cell 
infiltration]), TGI was comparable (97% versus 104% TGI, respectively). In the B16-F10 
model antitumor efficac followin amPD1-IL15ml treatment was de endent on 
had no impact on efficacy. In addition, administrntion of a T cell egress inhibitor, 
which inhibited T cell migration from lymph nodes to the tumor, did not affect amPD1- 
IL15mlinduced efficacy, suggesting T cell migration was not required for amPD1-IL15ml 
mediated anti-tumor immunity. Comparing amPD1-IL15ml to an IL-15 superagonist alone, 
amPD-1 mAb alone, or the combination of the IL-15 superagonist and amPD-1 in the B16- 
Fl 0 melanoma model, the PF-07209960 mouse smTogate was the most efficacious. 
PD-1 with a 
PF-07209960 to mouse PD-1. 
p ·ing SC versus IV 

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2.2.2. Nonclinical Pharmacokinetics and Metabolism 
Details of the nonclinical ADME evaluation of PF-07209960 are provided in the IB. Briefly, 
the nonclinical PK and TK of PF-07209960 were characterized following SC and IV dosing 
in cynomolgus monkeys as part of a PK/PD study and in explorato1y and GLP repeat dose 
toxicity studies. After single IV dosing of PF-07209960, dose-de endent PK was observed 
consistent with TMDD. Following single SC dosing, the 
 
. In the GLP toxicity study, systemic exposure increased with increasing 
dose, with little to no accumulation observed after repeat SC dosing. In humans, the PK of 
PF-07209960 is  redicted to be non-linear with clearance and volume of distribution ran ing 
 
SC 10avai a 1 1ty 1s assume to be 
similar to that observed in cynomolgus monkey. The projected clinical dose of PF-07209960 
rovide PF-07209960 concentrations above the predicted 
 
 
2.2.3. Nonclinical Safety 
ty study in cynomolgus monkeys 
 
) with integrated safety phannacology assessments was 
used to suppo1i FIH administration and ongoing clinical development of PF-07209960. In 
addition, the non • • 
• • 
ed in 2 non-GLP, QlW or 
Q2W repeat-dos 
dose finding toxicity studies in 
cynomolgus m 
• 
• ·ty 
levels, and enlarged spleen. Toxicities consistent with systemic inflammation and a dose- 
dependent cytokine-related response were observed from-. 
These 
toxicities including mo1iality, petechia and spontaneous b 
l mg/kg 
group, increased body temperature, reduced food consumption and activity, decreases in 
platelet counts and red blood cell mass parameters and increases in white blood cell counts 
(lymphocytes, monocytes, basophils and LUC), fibrinogen, CRP and coagulation parameters. 
Histopathological effects included increased cellulai·ity in lymphoid organs and minimal to 
marked infiltration of mononucleai·cells into vai·ious tissues, including the hea1i which was 
associated with mild cai·diomyocyte necrosis in two animals in the dose finding toxicity 
studies. Additional test article-related histopathological findings included tubular 
degeneration in kidneys and seminiferous tubular degeneration in the testes with severely 
reduced spe1m in animals administered PF-07209960 at-. The kidney-related 
findings conelated with increased blood urea nitrogen and creatinine concentrations. 
Findings in the toxicity studies ai·e consistent with the expected phannacology of PF- 
07209960 and were similai·between the SC and IV routes of administration. 
2.2.4. Clinical Overview 
This is a FIH study for PF-07209960, therefore, no clinical data is available. There ai·e 
cmTently no other PD-1-tai·geted IL-15 or IL-2 cytokines with available clinical data. 

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Anti-PD-1 therapy has become a standard of care in many different tumor types including 
NSCLC, RCC, SCCHN and UC, which will be evaluated in this study(KEYTRUDA 
(pembrolizumab), 2020; OPDIVO (nivolumab), 2020). However, treatment options 
following resistance to standard of care anti-PD-1 treatment remain an unmet need. 
For patients with OvCa and MSS CRC no standard of care immune therapy exists. Anti-PD-1 
therapy has been evaluated in OvCa with mixed results. Anti-PD-1 (ie, nivolumab, 
pembrolizumab, PF-06801591) antibodies have shown some single-agent, 
immunomodulatory and anti-tumor activity in participants with advanced OvCa (7%-22%), 
albeit to a much lower extent compared with other anti-PD-1 responsive tumor types 
(Hamanishi et al, 2015; Matulonis et al, 2018; Johnson et al, 2019; Varga et al, 2019). 
Intraperitoneal IL-2 administration in 31 patients with platinum resistant/refractory OvCa 
resulted in ORR 25% and CR rate of 17% (Vlad et al, 2010). Anti-PD-1 has been evaluated 
in CRC with 40% ORR in mismatch repair-deficient/microsatellite unstable disease but 0% 
ORR in mismatch repair-proficient/MSS disease, leading to approval for pembrolizumab 
only in mismatch repair-deficient disease (Le et al, 2015; KEYTRUDA (pembrolizumab), 
2020). Despite the lack of activity with anti-PD-1 in MSS CRC, it is well established that 
PD-1 is expressed on CRC tumor infiltrating CD8+ T cells and in tumor draining lymph 
nodes (Wu et al, 2014), and these cells exhibit an exhausted phenotype. However, the 
expression of IL-15 within tumors correlates with better prognosis and CD8+ T cell 
expression levels (Mlecnik et al, 2014). Thus, targeting IL-15 to OvCa and CRC tumors 
through PD-1 may provide better activation and expansion of tumor infiltrating lymphocytes 
and potentially improve upon past results with immunotherapy in these tumor types. 
High dose IL-2, which is approved for treatment of melanoma and RCC, is characterized by 
severe toxicities secondary to capillary leak syndrome, but these are not expected at lower 
doses (PROLEUKIN (aldesleukin), 2019). Second generation IL-2 therapies avoid binding to 
IL2-Rα. Bempegaldesleukin, a pegylated recombinant IL-2 is being studied in clinical trials 
with immune checkpoint inhibitors and has been well-tolerated. In a single-arm, Phase I 
dose-escalation trial of bempegaldesleukin in combination with nivolumab in advanced solid 
tumors, dose-limiting toxicities were reported in 2 of 17 patients during dose escalation and 
included the adverse events of hypotension (n=1), hyperglycemia (n=1), and metabolic 
acidosis (n=1). The most common treatment-related adverse events were flu-like symptoms 
(86.8%), rash (78.9%), fatigue (73.7%), and pruritus (52.6%). Grade 3 or 4 treatment-related 
adverse events were observed in 21.1% of patients and there were no treatment-related deaths 
(Diab et al, 2020). Response rates across tumor types (melanoma, RCC, and NSCLC) and 
dose cohorts was 59.5% (22 of 37) and 18.9% complete responses (7 of 37). Approaches to 
target a mutant IL-2 variant with reduced binding to IL2-Rα through antibodies to 
carcinoembryonic antigen in CRC and fibroblast activation protein expressed on cancer- 
associated fibroblasts have demonstrated a tolerable profile. In a biodistribution and tumor 
accumulation sub-study, 24 patients with advanced solid tumors were treated with 
cergutuzumab amunaleukin (CEA-IL2v). The most frequently observed adverse events 
related to treatment were infusion-related reactions (63%), pyrexia (54%), fatigue (46%), and 
nausea (46%). Four patients discontinued treatment due to AEs (pain, dyspnea, pulmonary 
hypertension and diarrhea) (van Brummelen & Huisman, 2018). RO6874281 (FAP-IL2v) 
was given in doses from 5 to 35 mg weekly IV to 35 patients with metastatic solid tumors 

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with most frequent adverse events (primarily Grade 1 or 2) of pyrexia, infusion related 
reactions, fatigue or asthenia, nausea, diarrhea, decreased appetite, and elevated alanine or 
aspartate transaminases in >30% of patients. Maximum tolerated dose was 20 mg. Objective 
response were observed in 3 patients with HNSCC, penile squamous cell carcinoma and 
checkpoint inhibitor-resistant melanoma (Soerensen et al, 2018). 
Recombinant human IL-15 (rhIL-15) given intravenously daily over 12 days has been linked 
to severe toxicities including grade 3 fever and DLTs of grade 3 hypotension, 
thrombocytopenia, and ALT and AST elevations at 1 and 3 μg/kg per day resulting in an 
MTD of 0.3 μg/kg per day (Conlon et al, 2015). Continuous IV infusion of rhIL-15 over 
10 days allowed for an increase in the MTD to 2 μg/kg/day (Conlon et al, 2019). In both 
studies with IV rhIL-15, no objective responses were seen. ALT-803, which is a variant of 
IL-15 with greater stability and potency than rhIL-15, has been tested intravenously and 
subcutaneously and appeared to be more tolerable as a subcutaneous monotherapy (Margolin 
et al, 2018). It has also been administered subcutaneously in combination with nivolumab 
safely (Wrangle et al, 2018). 
 
In the FIH Phase I trial of ALT-803, 24 patients with advanced solid tumors received 0.3 to 6 
μg/kg weekly IV (n=11) or 6 to 20 μg/kg weekly SC (n=13) for 4 consecutive weeks, every 6 
weeks. Overall, ALT-803 was well tolerated, with IV toxicities being primarily of low grade 
(Grades 1–2) and consistent with cytokine administration: fatigue (55%), nausea (55%), 
vomiting (36%), chills (36%) and fever (27%). For the SC administration, the most common 
adverse event occurring in 85% of patients was injection site reaction, described as a large 
wheal around the prior injection site with onset at approximately 3 days, peak intensity at 5 
days, and resolution by 7 days following the injection (Margolin et al, 2018). No clinical 
responses were observed in this study. 
 
ALT-803 IV or SC once weekly for 4 doses (dose levels of 1, 3, 6, and 10 μg/kg) was also 
studied in 33 patients with hematologic malignancies who relapsed after allogeneic 
hematopoietic cell transplantation. There were no dose-limiting toxicities or treatment- 
emergent graft-versus-host disease requiring systemic therapy. Adverse events following the 
IV administration included constitutional symptoms (infusion-related fever and chills) 
temporally related to increased serum IL-6 and interferon-γ. Patients treated with the SC 
administration experienced injection site rashes (94%) without constitutional symptoms. All 
rashes resolved without systemic therapy by day 14. Hypertension was observed following 
both the IV and SC administration in 83% of patients but was transient and not clinically 
serious. None of the patients experienced severe cytokine release syndrome or capillary leak 
syndrome. A fatal intracranial hemorrhage (n = 1) was associated with disease-related 
thrombocytopenia (Romee et al, 2018). Out of 27 patients evaluable for response, 1 had 
complete response, 1 had partial response and 3 had stable disease. 
ALT-803 in combination with nivolumab was evaluated in 21 patients with stage IIIB or IV 
NSCLC in a Phase 1b trial. Patients received nivolumab IV at 3 mg/kg or 240 mg flat dose 
every 14 days and ALT-803 SC at one of four escalating dose concentrations: 6, 10, 15, or 
20 μg/kg once per week on weeks 1–5 of four 6-week cycles for 6 months. No DLTs were 
recorded, and the maximum tolerated dose was not reached. The most common adverse 

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events were injection-site reactions (90%) and flu-like symptoms (71%). The most common 
grade 3 adverse events, occurring in two patients each, were lymphocytopenia and fatigue. A 
grade 3 myocardial infarction occurred in one patient. No grade 4 or 5 adverse events were 
recorded (Wrangle et al, 2018). Of all patients treated, objective responses were seen in 29% 
(6 of 21) patients including 3 who were PD-1 relapsed and refractory and 3 who were PD-L1 
negative. 
As PF-07209960 is designed to preferentially target IL-15 to PD-1, which is preferentially 
expressed by tumor infiltrating T cells, it is expected to have more specific stimulation of 
tumor-specific T cells rather than a generalized stimulation of multiple non-specific 
lymphocytes. Although the stimulation of CD8+ TIL appears to be dose dependent, at higher 
doses, PF-07209960 may also stimulate more non- PD-1 expressing lymphocytes such as NK 
cells, thus causing more systemic toxicity. At the RP2D, it is expected that the dose will be 
tolerated with meaningful anti-tumor activity thus providing a positive benefit/risk ratio. 
2.3. Benefit/Risk Assessment 
No human studies have been conducted to date evaluating PF-07209960, as this is the FIH 
study. For selected disease indications where participants do not have access to curative 
treatment options, the benefit/risk relationship has been carefully considered in the planning 
of this trial based on pre-clinical, toxicology studies and safety profiles of PF-07209960. 
Safety findings with PF-07209960 that were observed in the nonclinical studies include: 
fever, diarrhea, thrombocytopenia and immune cell infiltration of organs. During this Phase 1 
study, clinical assessments will include frequent safety monitoring. The participants will be 
monitored during and following their first dose with a 72-hour inpatient hospitalization 
period. This will be implemented throughout dose escalation and length of inpatient 
hospitalization will be re-assessed based on safety data prior to starting dose expansion 
cohorts. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of PF-07209960 may be found in the IB, which is the SRSD for this study. 

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2.3.1. Risk Assessment 
 
Potential Risk of Clinical Significance 
. 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Study Intervention(s) PF-07209960 
CRS 
The potential risks are based on pre-clinical 
toxicology data for PF-07209960 and prior clinical 
experience with the IL-15 and anti-PD-1 drug 
classes. 
CRS: Participants will be closely monitored with 
72 hour inpatient hospitalization on first dose at 
least for all in dose escalation. Guidelines for the 
management of CRS (Appendix 9) and irAEs 
(Appendix 14) have been incorporated. 
If the IV route is evaluated, there will be a 
minimum 72-hour interval between the first dose 
administered to each of the initial 2 participants 
enrolled at a new dose level to allow the detection 
of CRS. For C1D15 PF-07209960 IV 
administration, participants should remain at the 
investigational site for observation for at least 8- 
hours post dose. 
Thrombocytopenia including bleeding 
Thrombocytopenia: Participants must have both 
adequate hematological functions (including 
platelet counts) and coagulation functions to be 
eligible to participate in this study. Hematological 
and coagulation functions will be performed 
throughout. Anti-coagulants must be held for low 
platelet counts, and anti-platelet medications must 
be held for at least the first week of treatment. 
Abnormal liver function, abnormal kidney 
function 
Abnormal liver and kidney functions: Participants 
must have adequate liver function and kidney 
functions to be eligible to participate in this study. 
Liver and kidney function tests will be performed 
throughout the study. 

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Potential Risk of Clinical Significance 
Smnma1-y of Data/Rationale for Risk 
Mitigation Strategy 
 
 
irAEs including myocarditis 
 
 
 
 
 
Male infertility due to low sperm count 
Study Intervention(s) PF-07209960 
 
 
irAEs including myocarditis: Pa1ticipants must 
have a LVEF:?:50% by echocardio 
MUGA to be eli0ible. 
 
 
 
Male pa1ticipants should be counseled on option 
of fe1tility preservation. 
 
 
 
 
SC injection site reaction. 
There is a risk associated with any SC injection. 
ISRs will be monitored at each injection. 
 
 
 
De novo (fresh) tumor biopsy 
• 
stinging pain from injection of local 
anesthetic; 
• 
pain or discomfo1t from the biopsy 
procedure; 
• 
disco1nfo1t from lying still for an extended 
time; 
• 
bleeding, swelling, scan-ing, soreness, or 
bruising at the biopsy site; 
• 
infection of wound 
contamination of cancer cells to unaffected tissue 
when removing biopsy needle. 
Study Procedures 
 
There is a risk associated with any tumor biopsy. 
 
 
Local anesthetic will be administered. 
Sterile techniques will be used. 
Procedures will be perfonned by qualified 
medical practitioners. 
Mandatory fresh biopsies will be limited to dose 
expansion (Pait 2). 
Participants should not be subjected to a 
significant risk procedure to obtain the biopsies 
(ie, the absolute risk of mortality or major 
morbidity in the pa1ticipant's clinical setting and 
at the institution completing the procedure should 
be<2%). 

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2.3.2. Benefit Assessment 
There is a potential benefit of the pa1ticipant's tumors shrinking due to the study treatment, 
which could translate into an improvement in cancer-related symptoms or prolonged PFS or 
OS. The paiticipant would also be contributing to the development of a novel therapy in an 
ai·ea of unmet need. Medical evaluations and assessments on the study will allow for better 
monitoring of the pa1ticipants and recognition of AEs whether related to treatment or not. 
2.3.3. Overall Benefit/Risk Conclusion 
Taking into account the measmes taken to minimize risk to paiticipants in this study, the 
potential risks identified in association with PF-07209960 ai·e justified by the anticipated 
benefits that may be afforded to participants with advanced or metastatic solid tumors. 
3. OBJECTIVES AND ENDPOINTS 
 
PART 1 DOSE ESCALATION 
Objectives 
Endpoints 
Primary: 
 
• 
To assess safety and tolerability at increasing dose 
levels of PF-07209960 in participants with select 
locally advanced/metastatic solid tumors in order 
to estimate the MTD and select the RP2D/schedule. 
• 
First cycle DLTs. 
• 
 AEs as characterized by type, frequency, severity (as 
graded by NCI CTCAE version 5.0; for CRS as graded 
by ASTCT criteria), timing, seriousness, and 
relationship to study therapy. 
• 
 Laboratory abno1malities as characterized by type, 
frequency, severity (as graded by NCI CTCAE 
version 5.0), and timing. 
l' : 
• 
To chara.cterize the single and multiple dose PK of 
PF-07209960. 
.
e Single dose: Cmax, Tmax, AUCtau, If data permits, 
. 
AUCinr, CL/F, t112; 
Multiple Dose: Cma."<,Ss, Tmax,ss, AUCtau,ss, If data pe1mits, 
CLssfF, t112,ss,and Rae; 
Ctrou  at selected time oints• 
• 
To evaluate the inimunogenicity of PF-07209960. 
Incidence, titers and endogenous IL-15 cross-reactivity 
of ADA and NAb aoainst PF-07209960· 
• 
To evaluate prelimina1y anti-tumor activity. 
. 
ORR, DCR as assessed using the RECIST version 1.1. 
Time-to-event endpoints: DOR, PFS, and TTP by 
RECIST version 1.1 
Ex lorato1 : 

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PART 2 DOSE EXPANSION 
Ob"ectives 
End oints 
 
Primai-: 
• 
To confinnsafety and tolerability of 
PF-07209960 at the RP2D in participants with 
selected tumor types. 
• 
 To evaluate prelim.ina1y evidence of anti-tumor 
activity of PF-07209960 in pa1ticipants with 
selected tumor types. 
• 
 AEs as characterized by type, frequency, severity (as 
graded by NCI CTCAE version 5.0; for CRS as graded 
by ASTCT criteria), t.iniing, seriousness, and relationship 
to study therapy. 
• 
 Laboratory abno1malities as characterized by type, 
frequency, severity (as graded by NCI CTCAE 
version 5.0), and t.iniing. 
• 
ORR as detennined b RECIST version 1.1. 
Seconda1 : 
Seconda1 : 
• 
To fmther evaluate the PK of PF-07209960 at the 
RP2D. 
• 
Single dose: Cmax, Tmu, AUC1au. If data pennits, AUCinf, 
CL/F, t½; 
• 
Multiple Dose: Cmax,ss, Tmax,ss, AUCtau,ss. If data pennits, 
CLssfF, t112,ss, and Rae; 
• 
Ctrough at selected time points. 
• 
To evaluate the immunogenicity of PF-07209960. 
• 
Incidence, titers and endogenous IL-15 cross-reactivity of 
ADA and NAb against PF-07209960. 
• 
To evaluate the effect of PF-07209960 on 
immune cells in tumor biopsies. 
• 
Intra-tumor T cells (such as by CDS IHC) in on-treatment 
versus baseline tumor biopsy samples. 
• 
To evaluate prelim.ina1y anti-tumor activity 
through time to event endpoints. 
• 
DCR, DOR, PFS, and TTP by RECIST version 1.1 
• 
To assess overall survival of participants treated 
with PF-07209960. 
• 
Overall survival 
Ex 
I 
I 
 
 
 
 
 
 
 

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4. STUDY DESIGN 
4.1. Overall Design 
This is a Phase 1, open-label, multi-center, multiple-dose, dose escalation, safety, PK and PD 
study of PF-07209960 in cohoits of adult paiticipants with selected locally advanced or 
metastatic solid tumors (anti-PD-1/PD-Ll resistant- NSCLC, SCCHN, RCC, UC; or 
anti-PD-I nai:ve OvCa and MSS CRC) for whom no standard therapy is available or in the 
opinion of the paiticipant and their treating physician, that standai·d therapy would not be 
appropriate, or who have refused standai·d therapy. 
The study contains 2 paits, single agent dose escalation (Pait 1) followed by a dose 
expansion at RP2D (Pait 2). Following the detennination of the RP2D based on sequential 
dose escalation coholis with single agent PF-07209960 in Pait 1, the respective expansion 
cohoits in Pait 2 will commence. 
The Pait 2 dose expansion phase will consist of up to 5 cohoits, which will evaluate safety 
and anti-tumor activity of PF-07209960 at the RP2D determined in Pait 1. Opening of 
cohoits in Pait 2 will initially include tumor type(s) and setting(s) deemed more likely to 
demonstrate anti-tumor activity based on data from Pait 1. At this time, Pait 2 expansion 
cohoits in NSCLC, RCC and UC have been chosen due to their responsiveness to 
irmnunotherapy agents, and only if preliminaiy anti-tumor activity is seen with OvCa and 
MSS CRC in Pait 1 or in NSCLC, RCC, and UC in Pait 2, OvCa and MSS CRC expansion 
cohoits would be considered for emollment. TUillor indications for Pait 2 could be re- 
prioritized based on emerging data from Pait 1. Dose escalation and expansions combining 
PF-07209960 with anti-PD-LI or other agents may be added through protocol amendment 
based on emerging data. The overall study design is depicted in the schema (Section 1.2). 
BLRM guided by EWOC principle will be used to guide dose escalation process and 
detennine the MTD/RP2D (Pait 1). Successive cohoits of paiticipants in Pait 1 will receive 
escalating doses of PF-07209960 as a SC injection eveiy 2 weeks in 28-day cycles; the SC 
route has the potential to reduce the Cmax which is believed to be associated with CRS and 
 
 
 
 

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inflammatory responses, a common AE for agents that stimulate T cells. If excessive ISR or 
unexpected low exposure is encountered with SC dosing, an alternative IV infusion Q2W 
administration may be explored. The IV dose escalation/finding would begin at a starting 
dose based on the available emerging clinical data (including safety/tolerability, PK, PD) 
from the dose escalation cohorts with SC Q2W administration. The first and second 
participant in each dose level must be enrolled >72 hours apart. 
Approximately 14-22 participants are expected to be enrolled into Part 1 and approximately 
60-90 participants will initially enroll into the first three cohorts in Part 2. Based on emerging 
data, with the option to further enroll approximately 40-60 participants in an additional two 
cohorts in Part 2. Clinical response will be continuously monitored in each expansion cohort 
and if no clinical benefit is observed enrollment may be stopped in the respective cohort. 
All participants will complete up to 28 days of screening prior to enrollment. 
Eligible participants will receive PF-07209960 as a SC injection or IV infusion on Days 1 
and 15 as described in Section 4.3.1. A cycle will consist of 28 days and treatment with study 
intervention will continue until progression of disease, unacceptable toxicity, participant 
refusal, or whichever is earliest, unless the investigator and medical monitor agree to 
treatment beyond disease progression based on individual benefit/risk assessments or agree 
to discontinue treatment or the study is terminated. Participants will be allowed to stay on 
treatment despite initial radiological disease progression per RECIST version 1.1 (Eisenhauer 
et al, 2009) if all of the following criteria are met: 
• The investigator feels that it is in the participant’s best interest and has discussed with 
the medical monitor; 
• There is absence of symptoms and signs indicating clinically significant progression 
of disease; 
• There is no decline in performance status; 
• There is absence of symptomatic rapid disease progression requiring urgent medical 
intervention (eg, symptomatic pleural effusion, spinal cord compression); 
• It is documented that the participant consents to continued participation in the study 
even after being informed of all available approved therapies and their potential 
clinical benefit that they may be forgoing in order to continue the study intervention. 
Participants experiencing toxicity including a DLT may be managed with dose modification 
or discontinuation from treatment. The proposed doses, schedule(s) and PK time points may 
be reconsidered and amended during the study based on the emerging safety and PK data. 
Assessment of late toxicities will also be completed after the DLT observation period of 28 
days after C1D1 for all participants. Once a dose level has been declared safe following the 
post DLT observation window, participants at lower dose levels who have completed the 
DLT observation period may escalate to the next higher dose level, if criteria outlined in 
Section 4.3.2.1, Criteria for Intraparticipant Dose Escalation, have been met. 

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Participants continuing to experience AEs following discontinuation of treatment will 
continue to be followed at least every 4 weeks until resolution or determination, in the 
clinical judgment of the investigator, that no further improvement is expected. Participant 
will continue a 1-month follow-up visit after the last dose for AE and SAE follow-up if 
necessary. After the 1-month follow-up, participants will be contacted by telephone every 
8 weeks (±7 days) to obtain information on subsequent anticancer treatment, any AEs/SAEs 
experienced up to 90 days after the last dose, and survival status until the end of the study 
(Section 4.4). If the unresolved AE is considered by the investigator as possibly related to or 
associated with ADA formation, the participant will be asked to return to the clinic for ADA 
assessment at approximately 3 month intervals (if feasible given the underlying disease) until 
the AE or its sequelae return to baseline or stabilize at a level acceptable to the investigator 
and sponsor, until the last follow-up of the AE. 
The biomarker studies will be used to help understand the in vivo mechanism of action of the 
agent(s) studied as well as potential mechanisms of resistance. The studies may help in the 
future development of PF-07209960 as a single agent, or in combination with other 
compounds, and may provide information on tumor sub-types that may respond to the study 
intervention. 
4.2. Scientific Rationale for Study Design 
In this study, all participants will receive PF-07209960. No reproductive or developmental 
toxicity studies have been performed. Based on the mechanism of action, the risk of 
teratogenicity is considered possible while there is no risk of clinically relevant genotoxicity 
or transmission of drug via ejaculate. Therefore, the use of a highly effective method of 
contraception is required (see Appendix 4, Section 10.4.2 and Section 10.4.3). 
Participants may be asked to provide image-guided core needle biopsies at baseline and 
during treatment. When on-treatment biopsies are compared to baseline specimens, this 
information will enable the study of target engagement, optimal biologic dosing, and other 
genomic and translational markers of interest. Pre-treatment specimens to be collected from 
all patients as archival tissue and/or fresh tumor biopsies will enable study of baseline tumor 
markers that correlate with clinical outcomes. 
Tumor imaging will be carried out at a rate that is within the standard frequency for Phase 1 
oncology trials in solid tumors (every 8 weeks). 
Banked Biospecimens will be collected and stored for further analyses which may, for 
example, provide greater understanding of the study intervention. 
4.3. Justification for Dose 
Doses presented are projected based on nonclinical data and may be modified based on 
emerging safety, tolerability, and PK data. 

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4.3.1. Starting Dose 
4.3.1.1. Subcutaneous Dosing 
The selection of the staiiing dose and regimen for this FIH study was based on the 
nonclinical toxicology and PK results, which are in accordance with the ICH S9 Guidance 
(ICH S9 Guideline, 2009) for the intended population. For biophaimaceuticals with immune 
agonist prope1iies such as PF-07209960, selection of the FIH staiiing dose using a MABEL 
should be considered. Saber et al., concluded that the FIH doses based on 20% to 80% 
phaimacology activity from the most sensitive assays had acceptable/manageable toxicities 
for immune activatin antibodies exce t CD3 bis ecific constructs Saber et al, 2016; Saber 
et al, 2017). A 
dosing was derived 
based on the a 
at the projected 
 
 
 
 
se 1s a 
 
In addition to the MABEL approach, calculation of the staiiing dose based on 1/6 of the 
HNSTD from the definitive GLP toxici 
stud in monkeys was also considered. The 
dete1IDined 
 
2W dosing schedule), which 
conesponds to a FIH 
interspecies scaling of the 
animal doses to an equivalent human dose based on nonnalization to body surface area) SC. 
Therefore, the HNSTD derived dose for PF-07209960 would be lower com ai·ed to the 
 
The fixed-dose approach was chosen as it has been shown to provide similar PK vai·iability 
compai·ed to a body-weight adjusted dosing for monoclonal antibodies, therapeutic peptides, 
and proteins (Wang et al, 2009; Zhang et al, 2012). In addition, fixed dosing offers ease of 
prepai·ation and less chance of dosing enors. 
4.3.1.2. Alternative IV Dosing 
Based on the available emerging clinical data (including safety/tolerability, PK, PD) from the 
dose escalation coho1is with SC Q2W administi·ation, IV infusion Q2W administration may 
be explored in successive dose coho1is. If IV administration is inti·oduced, PF-07209960 will 
be administered over 1 hour (±10 minutes) without adjustment for body size at eve1y cycle as 
indicated in the IP manual. In case of change of the dosing regimen, DLT data accumulated 
during the dose escalation with the previously explored regimen may be used to fonn a prior 
disti·ibution for new BLRM paraineters. 
If the IV route is evaluated, there will also be a minimum 72-hour interval between the first 
dose administered to each of the initial 2 paiiicipants (ie, paiiicipants contributing to initial 
DLT evaluation) emolled at a new dose level to allow the detection of possible infusion 
MABEL derived dose. As a result 

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reactions or possible CRS. The participants will be monitored during and following their first 
dose with at least a 72-hour inpatient hospitalization period. This will be implemented 
throughout dose escalation and length of inpatient hospitalization will be re-assessed based 
on safety data prior to starting dose expansion cohorts. Participants should remain at the 
investigational site for observation for at least 1-hour post dose for all treatment visits after 
C1D1. Additional inpatient observation for subsequent cycles beyond C1D1 may be 
considered based on the investigator’s discretion and should be discussed with sponsor. 
As described in Section 4.3.1.1, the SC starting dose is 1.1 mg SC (rounded to 1 mg). The 
corresponding IV CCI 
 the projected exposure associated 
with the IV dose lower than the projected exposure associated with SC dosing (Table 1). 
 
Table 1. 
Projected Exposure After SC and IV Dosing 
 
Human Dose 
Cmax (µg/ml) 
AUC (µg*hr/mL) 
CCI 
The Cmax after IV dosing was calculated by the dose divided by the human plasma volume (2.8 L); the Cmax and AUC in 
human after SC, and the AUC after IV dosing were derived from the projected human PK profile extrapolated from 
monkey PK. 
The following scenarios would be used to determine the IV starting dose: 
Scenario 1: during the course of the clinical study, if the observed exposure at the highest 
safe/tolerable tested SC dose is higher than that of the projected exposure of the FIH starting 
SC dose, the IV starting dose will be adjusted using the same principle as described above to 
ensure the exposure of the IV starting dose does not exceed the exposure of the highest 
observed clinical safe/tolerable SC dose. 
Scenario 2: if the observed exposure at the highest safe/tolerable tested SC dose is lower 
than that of the projected exposure of the SC starting dose due to unexpectedly low 
bioavailability in human (bioavailability of 60% is assumed in the human PK projection), the 
IV starting dose will be the projected CCI 
 to the SC starting dose 
described above, provided that any dose limiting safety events observed in the clinical study 
following SC dosing are related to local SC injection (eg, skin toxicity at the local SC 
injection site) but not due to systemic exposure. 
4.3.2. Criteria for Dose Escalation 
In part 1, a 2-parameter BLRM guided by the EWOC principle will be used to model the 
dose-DLT relationship of PF-07209960 and guide the dose escalation. Using DLT data at all 
tested dose levels and pre-specified prior distribution of model parameters, the posterior 
distribution for probability of having a DLT falling into three dosing intervals (underdosing, 
target dosing, overdosing) will be calculated for all dose levels. A dose may only be used for 
newly enrolled participants if the risk of overdosing, ie, toxicity higher than 0.33 at that dose 
is less than 25%. 
Initially, dose escalation increases will be limited to no more than a half log increase from 
the previous dose level, which is a common approach for biologic compounds (Saber et al, 

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2016; Saber et al, 2017). Following the observation of a DLT in the current cohort, 
subsequent dose escalation increases will be limited to no more than 100%. A return to half 
log dose increases may be permitted at the discretion of the sponsor, in consultation with the 
participating investigators, if no DLT are seen at the following dose level. 
The provisional dose levels to be evaluated are listed in Table 2. 
 
Table 2. 
Provisional Dose Levels 
 
Dose Level 
SC 
IV infusion 
CCI 
a. 
The IV infusion doses are tentative IV and will be based on emerging data. 
b. 
To be determined by BLRM. 
 
The starting dose in Part 1 will be CCI 
 
Q2W as described in Section 4.3.1. In a very unlikely case of observing DLT(s) at 
the starting dose level, lower dose level (CCI 
) might be 
considered for dose de-escalation (see Section 6.6.3). The dose level will be recommended 
by BLRM in such a way that EWOC criteria is fulfilled. 
4.3.2.1. Criteria for Intraparticipant Dose Escalation 
Intraparticipant dose escalation to the next dose-level will be permitted in this study for 
participants in dose escalation phase. Toxicity data observed after intraparticipant dose 
escalation will not be included in the BLRM but will be taken into account to assess the 
overall safety of the doses the participants was administered. Intraparticipant dose-escalation 
to the next dose level is permitted if all of the following conditions are met. Further 
intraparticipant dose escalations are permitted and will be based on the same criteria for each 
escalation. 
1. The next dose level is deemed safe after at least the DLT evaluation period has been 
completed for all participants at that dose level. 
2. The candidate for intraparticipant dose-escalation tolerated the current dose level well, 
with highest drug-related toxicity observed being Grade 2 or below. 
3. Imaging for tumor response assessment can be performed within 1 week before start of 
treatment with the escalated dose if not done within the prior 28 days. 
4. A discussion between the investigator and sponsor has been completed, and it is agreed 
that this will be in the participant’s best interest. 

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4.3.3. Dose Limiting Toxicity Definition 
For the purpose of dose escalation, any of the following AEs will be classified as DLTs: 
• Occur in the first cycle of treatment, or within 28 days after the start of the study 
treatment; and 
• Are at least possibly related to PF-07209960; A participant is classified as DLT evaluable 
if he/she experiences a DLT or if he/she otherwise in the absence of a DLT receives 2 
doses of the study intervention during Cycle 1 and has received all scheduled safety 
assessments during the DLT window. If a participant fails to meet these criteria, he/she 
may be replaced. Monitoring for DLTs will occur during Part 1. 
Significant AEs considered to be related to the study intervention or treatment under 
investigation that occur after the DLT observation period will be reviewed in context of all 
safety data available. That review may result in re-evaluation of the dosing level or regimen. 
Hematologic DLTs: 
1. Grade 4 neutropenia (absolute neutrophil count [ANC] <500/mm3) lasting >7 days; 
2. Febrile neutropenia (defined as an ANC 1000/mm3, with a single temperature of 
 38.3°C [101°F], or a sustained temperature of ≥38°C [100.4°F] for more than one 
hour); 
3. Neutropenic infection (defined as an ANC 1000/mm3 with Grade ≥3 infection); 
4. Grade 3 thrombocytopenia (platelet count <50,000 mm3) with any bleeding; 
5. Grade 4 thrombocytopenia (platelet count <25,000/mm3); 
6. Grade 4 anemia (life-threatening consequences; urgent intervention indicated). 
Non-Hematologic DLTs: 
• Any Grade ≥3 non-hematologic treatment related AE is a DLT with the following 
exceptions: 
1. Grade 3 nausea, vomiting, diarrhea, or fatigue that can be controlled with or without 
medical therapy to Grade ≤2 within 72 hours; 
2. Grade ≥3 laboratory abnormalities without a clinical correlate and that do not require 
medical intervention, or are corrected to Grade ≤2 with supplementation/appropriate 
management within 72 hours; 
Immune-related AE (irAE) that meet the following criteria: 
1. Grade 4 irAE regardless of duration (for lab abnormalities without clinical correlate 
and do not require medical intervention please refer to criteria above); 

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2. Grade ≥3 colitis regardless of duration (diagnosis of colitis must be supported by 
diagnostic testing); 
3. Grade 3 non-infectious pneumonitis regardless of duration; 
4. Grade 2 non-infectious pneumonitis that does not resolve to ≤ Grade 1 within 72 
hours of the initiation of maximal supportive care; 
5. Any grade immune-mediated myocarditis; 
6. Grade 3 irAE, excluding colitis and pneumonitis, that does not improve to ≤ Grade 2 
within 72 hours after onset of the AE event despite maximal supportive care 
including systemic corticosteroids or downgrade to ≤ Grade 1 or baseline within 
14 days; 
7. Grade ≥3 immune-related endocrinopathies (eg, thyroid disorders, diabetes mellitus, 
adrenal insufficiency) that require treatment discontinuation or are not successfully 
managed with hormonal replacement therapy. 
Other cases that meet the following DLT criteria: 
1. Hy’s Law cases defined as: ALT or AST >3 x ULN if normal at baseline 
OR >3 x ULN and doubling the baseline (if >ULN at baseline) associated with total 
bilirubin >2 x ULN and an alkaline phosphatase <2 x ULN. 
2. A treatment related AE inducing a delay by ≥4 weeks in receiving the next scheduled 
cycle due to persisting toxicities attributable to PF-07209960 will be considered a 
DLT. 
3. Clinically important or persistent toxicities (eg, toxicities responsible for significant 
dose delay) that are not included in the above criteria may also be considered a DLT 
following review by the investigators and the sponsor. All DLTs need to represent a 
clinically significant shift from baseline. While the rules for adjudicating DLTs are 
specified above, an AE not listed above, or an AE meeting the DLT criteria above but 
occurring outside of the DLT observation period may be defined as a DLT following 
assessment, based on the emerging safety profile. 
4.3.4. Maximum Tolerated Dose Definition 
MTD is defined as a dose with true DLT rate from the target toxicity interval. The target 
interval for the DLT rate is defined as (0.16, 0.33). 
4.3.5. Maximum Feasible Dose Definitions 
Not applicable. 

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4.3.6. Recommended Phase 2 Dose Definition 
The recommended dose for further study (which is normally the same as the RP2D) is the 
dose chosen for further investigation based on Phase 1 dose escalation study results. If the 
MTD proves to be clinically feasible for long‑term administration in a reasonable number of 
participants, then this dose usually becomes the RP2D. Further experience with the MTD 
may result in a RP2D lower than the MTD. During escalation and prior to an MTD being 
reached, the sponsor may choose to advance a lower dose into expansion. This decision must 
be made based on safety, PK, PD, and/or efficacy. Furthermore, after reaching the MTD, up 
to approximately 6-12 participants may be enrolled in the lower doses for the purpose of 
refining the RP2D based on emerging safety data. 
Significant AEs considered to be related to the study intervention or treatment under 
investigation that occur after the DLT observation period will be reviewed in context of all 
safety data available. That review may result in re-evaluation of the MTD/RP2D for Part 2 
expansion cohort. 
4.4. End of Study Definition 
A participant is considered to have completed the study if he/she has completed all phases of 
the study, including the last visit. 
The end of the study will be the date of the last visit of the last participant or 2 years after the 
last participant receives their first dose (whichever occurs first) at which point all study 
participants will need to complete any protocol-specified post-treatment safety monitoring 
activities before final closure of the study. The study may also be terminated at any time at 
the discretion of the sponsor. 
5. STUDY POPULATION 
This study can fulfill its objectives only if appropriate participants are enrolled. The 
following eligibility criteria are designed to select participants for whom participation in the 
study is considered appropriate. All relevant medical and nonmedical conditions should be 
taken into consideration when deciding whether a particular participant is suitable for this 
protocol. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted. 
Pfizer will review eligibility criteria verified by the investigator or qualified designee to 
confirm that participants meet study eligibility criteria before they are enrolled into the study. 
The enrollment approval process will be initiated for a participant after an informed consent 
document has been signed and the investigator or qualified designee has assessed the 
participant as eligible. The enrollment approval will be based on review of CRF/system data. 

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5.1. Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Participants age ≥18 years. 
• Refer to Appendix 4 for contraceptive/reproductive criteria for male 
(Section 10.4.1) and female Section 10.4.2 participants. 
2. Histological or cytological diagnosis of locally advanced/metastatic solid tumor 
(NSCLC, SCCHN, RCC, UC, OvCa, or MSS CRC). 
a. At least 1 prior line of therapy for recurrent or metastatic disease, including either 
standards of care or investigational therapies. Participants must have progressed 
or relapsed after or be intolerant to standard therapy approved for the specific 
tumor type. Exception: participants who actively decline available standard of 
care therapies are eligible upon documentation of their refusal. 
b. Participants with NSCLC, SCCHN, RCC, or UC must have received prior 
anti-PD-1/PD-L1 either as monotherapy or in a combination regimen and had 
experienced radiographic progression. 
c. Participants with NSCLC must not have known ALK, ROS1, MET exon 14 
skipping, RET rearrangement or EGFR mutation. 
d. Participants who had received prior anti-PD-1 must be ≥90 days from their last 
anti-PD-1 dose. Participants who received prior anti-PD-L1 are not subject to this 
restriction. 
e. Participants with OvCa or MSS CRC must not have received prior anti-PD- 
1/PD-L1 therapy. 
f. Demonstrated radiographic progression on most recent tumor assessment 
imaging. 
g. For Part 2, in addition: 
a) Participants with NSCLC must have received either ≥2 prior lines of therapy 
including a ≥1 prior regimen containing chemotherapy and ≥1 prior regimen 
containing anti-PD-1/PD-L1 or a prior regimen of anti-PD-1/PD-L1 in 
combination with chemotherapy (eg, atezolizumab with chemotherapy). In 
addition, NSCLC with a BRAF V600E mutation must have also received 
BRAF inhibitor with or without MEK inhibitor 
b) Participants with RCC must have received either ≥2 prior lines of therapy 
including ≥1 prior regimen containing anti-PD-1/PD-L1 and ≥1 prior regimen 
containing a small molecule kinase inhibitor or a prior regimen of 
anti-PD-1/PD-L1 in combination with a small molecule kinase inhibitor (eg, 
pembrolizumab or avelumab with axitinib). 
c) Participants with UC must have received ≥2 prior lines of therapy including 
platinum-containing chemotherapy and anti-PD-1/PD-L1, or a single regimen 

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of platinum-containing chemotherapy followed by anti-PD-1/PD-L1 
maintenance therapy. 
d) Participants with MSS CRC must have received ≥2 prior lines of therapy 
including treatment regimens containing combinations of pyrimidine analog, 
oxaliplatin, irinotecan, anti-EGFR (RAS wild type), encorafenib (if BRAF 
V600E-positive) and anti-HER2 (if HER2-amplified and RAS and BRAF 
wild type). 
e) Participants with OvCa must have received ≥2 prior lines of therapy including 
at least 1 regimen with platinum-based chemotherapy and progressed on last 
two consecutive regimens without evidence of clinical benefit. 
3. Participants entering the study in ≥1 measurable lesion (at least 10 mm in the longest 
diameter by CT scan/MRI for non-lymph nodes and at least 15 mm in the short axis 
for lymph nodes) as defined by RECIST version 1.1 that has not been previously 
irradiated. 
4. Must have tumor tissue available for submission to the sponsor: 
a. Participants enrolled in Part 1 and Part 2 should consent to undergo biopsy during 
screening (pre-treatment) or be able to provide archival FFPE material containing 
tumor that is of diagnostic quality and representative of their diagnosed 
malignancy taken ≤1 year prior to study start. If the archival sample is older than 
1 year and a biopsy during screening cannot be performed, the investigator must 
contact the sponsor to discuss eligibility prior to enrollment. 
b. Participants enrolled in Part 2 dose expansion must have a tumor amenable to 
biopsy and consent to planned mandatory pre- and on-treatment biopsy 
procedures until the sponsor deems that an adequate number of participants (10- 
15 paired fresh biopsies per cohort) have been successfully biopsied, at which 
point participants will only be required to submit pre-treatment biopsies (either 
archival tissue or de novo biopsy as above). Special considerations will be made 
for participants with poorly accessible tumors or deemed medically unsafe as 
determined by the investigator after discussion and agreement by the sponsor. 
5. ECOG PS 0-2 for Part 1, 0-1 for Part 2. 
6. Adequate hematologic function, including: 
a. ANC 1,500/mm3 or 1.5 x 109/L; 
b. Platelets 100,000/mm3 or 100 x 109/L; 
c. Hemoglobin 9 g/dL. Limited transfusions to reach this value are allowed, after 
discussion with the sponsor’s medical monitor. There should not be chronic need 
for transfusions (>1 per month) in the recent (approximately 3 months) past. 
7. Adequate renal function, including: 
d. Estimated creatinine clearance 50 mL/min as calculated by Cockcroft-Gault 
method. In equivocal cases, a 24-hour urine collection test can be used to estimate 
the creatinine clearance more accurately. 

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8. Adequate liver function, including: 
a. Total serum bilirubin 1.5 x ULN; 
b. AST and ALT 2.5 x ULN; 5.0 x ULN if there is liver involvement by the 
tumor; 
c. Alkaline phosphatase 2.5 x ULN (5 x ULN in case of bone metastasis). 
9. Adequate coagulation function, including: 
a. INR or aPTT ≤1.5 x ULN. 
10. LVEF ≥50% by echocardiogram or MUGA. 
11. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 
except for AEs not constituting a safety risk by investigator judgment. 
12. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, 
lifestyle considerations, and other study procedures. 
13. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and in 
this protocol. 
5.2. Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Known symptomatic brain or leptomeningeal metastases requiring steroids. 
Participants with previously diagnosed brain or leptomeningeal metastases are 
eligible if they have completed their treatment and have recovered from the acute 
effects of radiation therapy or surgery prior to planned first dose, have discontinued 
corticosteroid treatment for these metastases for at least 4 weeks and are 
neurologically stable for 3 months (requires MRI confirmation). 
2. Any other active malignancy within 3 years prior to enrollment, except for adequately 
treated basal cell or squamous cell skin cancer, or carcinoma in situ. 
3. Major surgery within 4 weeks prior to planned first dose. 
4. Radiation therapy within 4 weeks prior to planned first dose. 
5. Systemic anti-cancer therapy within 4 weeks prior to planned first dose (6 weeks for 
mitomycin C or nitrosoureas). If the last immediate anti-cancer treatment contained 
an antibody-based agent(s) (approved or investigational), then an interval of 28 days 
or 5 half-life (whichever is shorter) of the agent(s) prior to receiving the study 
intervention treatment is required. Participants who received anti-PD-1 therapy (but 
not anti-PD-L1) require an interval of 90 days prior to planned first dose. 
6. Active and clinically significant bacterial, fungal, or viral infection, Hepatitis B or 
Hepatitis C infection at screening (positive HBsAg or positive HCV RNA if 
anti-HCV antibody test positive), known HIV or AIDS-related illness. HIV 
seropositive participants, who are in good health and at low-risk for AIDS-related 

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outcomes, may qualify for inclusion in the study after discussion with the sponsor, 
but AIDS is exclusionary. 
The following criteria for immune status and HIV ongoing therapy must be met for a 
HIV seropositive participant to be eligible for the study: 
a) Immune status criteria: 
a. CD4+ T-cell counts ≥350 cells/μL at the study start; 
b. No history of AIDS-defining opportunistic infections; 
c. In general, patients should be eligible if they have not had an opportunistic 
infection within the past 12 months. 
b) Ongoing HIV therapy criteria: 
d. Must be receiving recommended concurrent ART treatment according to the 
guidelines (AIDSinfo, 2020); 
e. Began ART treatment >4 weeks prior to study start (to ensure ART is 
tolerated and toxicities are not confused with study drug toxicities); 
f. HIV viral load <400 copies/mL for >4 weeks prior to study start (to ensure 
ART is tolerated and HIV controlled). 
7. Active COVID-19/SARS-CoV2: Refer to Appendix 10 for further information. 
8. Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may 
affect participant safety or interpretation of study results (eg, baseline QTc interval 
>470 msec, complete LBBB, signs of an acute or indeterminate-age myocardial 
infarction, ST-T interval changes suggestive of active myocardial ischemia, 
second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). 
If the baseline uncorrected QT interval is >470 msec, this interval should be 
rate-corrected using the Fridericia method and the resulting QTcF should be used for 
decision making and reporting. If QTc exceeds 470 msec, or QRS exceeds 120 msec, 
the ECG should be repeated 2 more times and the average of the 3 QTc or QRS 
values should be used to determine the participant’s eligibility. Computer-interpreted 
ECGs should be overread by a physician experienced in reading ECGs before 
excluding participants. Cases must be discussed in detail with sponsor’s medical 
monitor to judge eligibility. 
9. Any of the following in the previous 6 months: myocardial infarction, long QT 
syndrome, Torsade de Pointes, arrhythmias (including sustained ventricular 
tachyarrhythmia and ventricular fibrillation), serious conduction abnormalities (e.g., 
bifascicular block [defined as right bundle branch and let anterior or posterior 
hemiblock], 3rd degree AV block), unstable angina, coronary/peripheral artery bypass 
graft, symptomatic CHF, New York Heart Association class III or IV, 
cerebrovascular accident, transient ischemic attack, symptomatic pulmonary 
embolism, and/or other clinical significant episode of thrombo embolic disease. 
Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any 
grade (Grade ≥2 in the case of asymptomatic lone atrial fibrillation). If a participant 

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has a cardiac rhythm device/pacemaker placed and QTcF >470 msec, the participant 
can be considered eligible. Participants with cardiac rhythm device/pacemaker must 
be discussed in detail with sponsor’s medical monitor to judge eligibility. 
10. Abnormal cardiac valve morphology (≥grade 2) documented by echocardiogram 
(participants with grade 1 abnormalities [ie, mild regurgitation/stenosis] can be 
enrolled on study). Participants with valvular thickening should not be enrolled into 
the study. 
11. Anticoagulation with vitamin K antagonists is not allowed. Anticoagulation with low 
molecular weight heparin and Factor Xa inhibitors or use of antiplatelet therapy is 
allowed but must be held per institutional requirements for biopsies and whenever 
platelet count is <50,000/mm3. If participants are on antiplatelet therapy, they must be 
able to hold antiplatelet therapy for first week of study treatment without significantly 
increased risk of cardiovascular events. 
12. AEs from prior therapy which have not recovered to Grade ≤1 or baseline. 
13. Hypertension Grade 3 or higher (eg, ≥160/100 mmHg) that cannot be controlled by 
medications despite optimal medical therapy. 
14. Participation in other studies involving investigational drug(s) within 4 weeks prior to 
first dose. 
15. Known or suspected hypersensitivity to any PF-07209960 components, or to mAbs or 
other therapeutic proteins such as fresh frozen plasma, human serum albumin, 
cytokines, or interleukins. 
16. History of clinically significant Grade 3 immune mediated AE that was considered 
related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co 
stimulatory agents, etc.) and required immunosuppressive therapy. Patients with 
immune-mediated endocrinopathies controlled with hormonal replacement therapy 
(eg, thyroid disorders, diabetes, adrenal insufficiency) are eligible. 
17. Active autoimmune disease that might deteriorate when receiving an 
immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or 
hyperthyroid disease not requiring immunosuppressive treatment are eligible. 
18. Organ transplant requiring immunosuppressive treatment or prior allogeneic bone 
marrow or hematopoietic stem cell transplant. 
19. Current use of immunosuppressive medication at the time of randomization, 
EXCEPT for the following: a) intranasal, inhaled, topical steroids, or local steroid 
injection (eg, intra-articular injection); b) Systemic corticosteroids at physiologic 
doses ≤10 mg/day of prednisone or equivalent; c) Steroids as premedication for 
hypersensitivity reactions (eg, CT scan premedication). 
20. Active bleeding disorder, including gastrointestinal bleeding, as evidenced by 
hematemesis, significant hemoptysis or melena in the past 6 months prior to first 
dose. 
21. History of interstitial lung disease or pneumonitis. 

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22. Participants with the presence of any open, active wound. 
23. Pregnancy or breastfeeding. 
24. 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 or, in the investigator’s judgment, make the participant 
inappropriate for the study. 
25. Investigator site staff or Pfizer employees directly involved in the conduct of the 
study, site staff otherwise supervised by the investigator, and their respective family 
members. 
5.3. Lifestyle Considerations 
Not applicable, no restrictions are required. 
5.3.1. Contraception 
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected an appropriate method of contraception for the individual 
participant and his or her partner(s) from the permitted list of contraception methods (see 
Appendix 4) and will confirm that the participant has been instructed in its consistent and 
correct use. At time points indicated in the schedule of activities (SoA), 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 at least 1 
of the selected methods of contraception). In addition, the investigator or designee will 
instruct the participant to call immediately if the selected contraception method is 
discontinued or if pregnancy is known or suspected in the participant or partner. 
5.4. Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently enrolled in the study. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants to meet the CONSORT 
publishing requirements and to respond to queries from regulatory authorities. Minimal 
information includes demography, screen failure details, eligibility criteria, and any SAE. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened twice after the initial screen fail. 
6. STUDY INTERVENTION 
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, medical device(s), or study procedure(s) intended to be administered to a study 
participant according to the study protocol. 
For the purposes of this protocol, study intervention refers to PF-07209960. 

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6.1. Study Intervention(s) Administered 
 
Intervention Name 
PF-07209960 
ARM Name 
(group of participants receiving a specific 
treatment (or no treatment) 
All 
Type 
Biologic 
Dose Formulation 
Lyophilized powder for solution for injection or 
infusion 
Unit Dose Strength(s) 
10 mg/vial 
Dosage Level(s) 
Dose amount and frequency – reference the study 
scheme/figure or text below as appropriate. 
Route of Administration 
SC (or IV if necessary) 
Use 
Experimental 
IMP or NIMP 
IMP 
Sourcing 
Provided centrally by the sponsor. 
Specifics on ordering can be found in the IP manual. 
Packaging and Labeling 
Study intervention will be provided in single vials 
packaged in individual cartons. Each vial and carton 
will be labeled as required per country requirement. 
IP will be provided as open labeled material. 
Current Name 
PF-07209960, Targeted IL-15 
 
PF-07209960 10 mg/vial is presented as a sterile lyophilized powder for solution for SC or 
IV administration. Each vial contains 10 mg of PF-07209960 as a white cake essentially free 
from visible particulates in a 6 mL type I clear glass vial, sealed with a 13 mm lyo stopper 
and 13 mm aluminum flip-off seal. 
6.1.1. Administration 
PF-07209960 will be administered once every 2 weeks as a flat dose SC injection or IV 
infusion over 1 hour (±10 minutes). 
Each participant may receive PF-07209960 until disease progression, unacceptable toxicity, 
withdrawal of consent, or study termination. Treatment beyond disease progression may be 
discussed with sponsor if the investigator assesses that it is the participant’s best interest to 
continue with treatment and would not derive as much benefit from alternative therapy and 
has met the criteria for treatment beyond progression as outlined in Section 4 . 
Subcutaneous administration 
Qualified and trained investigator site personnel will administer PF-07209960 to participants 
by SC injection. Ideally, each injection may be up to 2 mLs in volume. However, if the 
maximum volume allowed per institution’s policy is lower, the number of injections may 

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increase to accommodate this difference in volume to ensure the correct final dose is 
delivered. 
Study drug should be administered to the abdomen (with preference given to the lower 
quadrants when possible). Refer to Appendix 12, for details on administration of multiple 
injections to the abdomen. Study staff should refer to the IP Manual for specific instructions 
on the handling and preparation of study drug. 
Cycle duration: A cycle is defined as 28 days, regardless of missed doses or dose delays. 
Intravenous administration 
Based on the available emerging clinical data (including safety/tolerability, PK, PD) from the 
dose escalation cohorts with SC Q2W administration, IV infusion Q2W administration may 
be explored in successive dose cohorts. If IV administration is introduced, PF-07209960 will 
be administered over 1 hour (±10 minutes) time period without adjustment for body size at 
every cycle as indicated in the IP manual. 
6.2. Preparation/Handling/Storage/Accountability 
1. The investigator or designee must confirm appropriate temperature conditions have 
been maintained during transit for all study interventions received and any 
discrepancies are reported and resolved before use of the study intervention. 
2. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention. All study 
interventions must be stored in a secure, environmentally controlled, and monitored 
(manual or automated recording) area in accordance with the labeled storage 
conditions with access limited to the investigator and authorized site staff. At a 
minimum, daily minimum and maximum temperatures for all site storage locations 
must be documented and available upon request. Data for nonworking days must 
indicate the minimum and maximum temperatures since previously documented for 
all site storage locations upon return to business. 
3. Any excursions from the study intervention label storage conditions should be 
reported to Pfizer upon discovery along with any actions taken. The site should 
actively pursue options for returning the study intervention to the storage conditions 
described in the labeling, as soon as possible. Once an excursion is identified, the 
study intervention must be quarantined and not used until Pfizer provides permission 
to use the study intervention. Specific details regarding the definition of an excursion 
and information the site should report for each excursion will be provided to the site 
in the IP manual. 
4. Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the label. 
5. Study interventions should be stored in their original containers. 
6. See the IP manual for storage conditions of the study intervention once reconstituted. 

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7. The investigator, institution, or the head of the medical institution (where applicable) 
is responsible for study intervention accountability, reconciliation, and record 
maintenance (ie, receipt, reconciliation, and final disposition records), such as the 
IPAL or sponsor-approved equivalent. All study interventions will be accounted for 
using a study intervention accountability form/record. 
8. Further guidance and information for the final disposition of unused study 
interventions are provided in the IP manual. All destruction must be adequately 
documented. If destruction is authorized to take place at the investigator site, the 
investigator must ensure that the materials are destroyed in compliance with 
applicable environmental regulations, institutional policy, and any special instructions 
provided by Pfizer. 
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IP Manual. 
6.2.1. Preparation and Dispensing 
See the IP manual for instructions on how to 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. 
Vials are single-use. 
Only qualified personnel who are familiar with procedures that minimize undue exposure to 
themselves and to the environment should undertake the preparation, handling, and safe 
disposal of biologic agents. 
6.3. Measures to Minimize Bias: Randomization and Blinding 
6.3.1. Allocation to Study Intervention 
Part 1: Dose Escalation 
Dose level allocation will be performed by the sponsor after participants have given their 
written informed consent and have completed the necessary baseline assessments. The site 
staff will fax/e-mail a complete Registration Form to the designated sponsor study team 
member or designee. The sponsor will assign a participant identification number and supply 
this number to the site. The participant identification number will be used on all study-related 
documentation at the site. 
No participant will receive study intervention until the investigator or designee has received 
the following information in writing from the sponsor: 
• Confirmation of the participant’s enrolment; 
• Specification of the dose level for that participant and; 
• Permission to proceed with dosing the participant. 

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Study intervention will be dispensed at the study visits summarized in the SoA. 
Returned study intervention must not be redispensed to the participant. 
Part 2: Dose Expansion 
If IRT will be utilized for Dose Expansion, allocation of participants to treatment groups will 
proceed through the use of an IRT system (IWR). If IRT will not be used, the Dose 
Expansion will follow the dose level allocation as indicated in the above Part 1, Dose 
Escalation section. The site personnel (study coordinator or specified designee) will be 
required to have an active or valid account and password with the IRT system, enter or select 
information including but not limited to the users’ ID and password, protocol number, 
specific protocol entrance criteria indicated in the system and the participant number. The 
site personnel will then be provided with, at a minimum, a treatment assignment, 
randomization number, and DU or container number when study intervention is being 
supplied via the IRT system. The IRT system will provide a confirmation report containing 
the participant number, randomization number, and DU or container number assigned. The 
confirmation report must be stored in the site’s files. 
Study intervention will be dispensed at the study visits as summarized in the SoA. 
Returned study intervention must not be redispensed to the participants. 
The study-specific IRT reference manual will provide the contact information and further 
details on the use of the IRT system. 
6.4. Study Intervention Compliance 
When participants are dosed at the site, they will receive study intervention directly from the 
investigator or designee, under medical supervision. The date and time of each dose 
administered in the clinic will be recorded in the source documents and recorded in the CRF. 
The dose of study intervention and study participant identification will be confirmed at the 
time of dosing by a member of the study site staff other than the person administering the 
study intervention. 
The site will complete the required dosage Preparation Record located in the IP manual. The 
use of the Preparation Record is preferred, but it does not preclude the use of an existing 
appropriate clinical site documentation system. The existing clinical site's documentation 
system should capture all pertinent/required information on the preparation and 
administration of the dose. This may be used in place of the Preparation Record after 
approval from the sponsor and/or designee. 
6.5. Concomitant Therapy 
Concomitant treatment considered necessary for the participant’s well-being may be given at 
discretion of the treating physician. 

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All concomitant treatments, blood products, as well as nondrug interventions received by 
participants from screening until the end of treatment visit will be recorded on the CRF. 
PF-07209960 has been demonstrated to transiently increase cytokine levels (eg, IL-6) in vivo 
in monkeys (also demonstrated via in vitro assays). Cytokines have been shown to result in 
modulation of the expression of some cytochrome P450 enzymes. Therefore, treatment with 
PF-07209960 may potentially result in modest increase in the exposure of concomitant 
medications that are substrates for these enzymes. Caution should be used upon concomitant 
use of sensitive substrates of cytochrome P450 enzymes with narrow therapeutic index (eg, 
CYP3A4: alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, 
quinidine, sirolimus and tacrolimus; CYP2C9: phenytoin, warfarin) especially during the 
initial treatment cycle. 
6.5.1. Other Anti-tumor/Anti-cancer or Experimental Drugs 
No additional anti-tumor treatment will be permitted while participants are receiving study 
treatment. Additionally, the concurrent use of vitamins beyond a daily multivitamin or 
supplementation for a documented vitamin deficiency or herbal supplements is not permitted. 
6.5.2. Radiation Therapy 
Palliative radiotherapy to a limited field but not to a target lesion(s) is allowed after 
consultation with sponsor’s Medical Monitor at any time during study participation, 
including during screening, unless clearly indicative of disease progression. In view of the 
current lack of data about the interaction of PF-07209960 with radiotherapy, PF-07209960 
treatment should be interrupted during palliative radiotherapy, stopping 7 days before and 
resuming treatment after 7 days. If the effects of palliative radiotherapy on overall anti-tumor 
efficacy cannot be clearly distinguished from those of PF-07209960 following radiotherapy, 
response assessments after radiotherapy should be considered as non-evaluable. 
6.5.3. Supportive Care 
Palliative and supportive care for disease related symptoms may be administered at the 
investigator’s discretion and according to the specific supportive care product Prescribing 
Information or the current ASCO guidelines (ASCO, 2020). 
6.5.4. Hematopoietic Growth Factors 
During the 14 days prior to Day 1, granulocyte colony stimulating factors are not permitted 
to qualify a participant with low WBC counts. 
Primary prophylactic use of colony stimulating factors is not permitted during the first 
28 days of Cycle 1 Part 1, but they may be used to treat treatment emergent neutropenia as 
indicated by the current ASCO guidelines (ASCO, 2020). 
Erythropoietin may be used at the investigator’s discretion for the supportive treatment of 
anemia. 

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6.5.5. Anticoagulation Therapy 
Anticoagulation therapy with vitamin K antagonists is prohibited throughout the study and 
for at least 28 days post the last dose of study treatment. Anticoagulation with low molecular 
weight heparin and Factor Xa inhibitors or use of antiplatelet therapy is allowed but must be 
held per institutional requirements for biopsies and whenever platelet count is 
<50,000/mm3 or when active bleeding occurs and resume only when platelet count is 
>50,000/mm3 and there is no bleeding. 
Antiplatelet therapy must be held during the first week of PF-07209960 and may resume if it 
is observed that the platelet count does not drop below 50,000/mm3 the first week after 
receiving PF-07209960, and the platelet count has reached a nadir and shown a subsequent 
increase. If platelet count does drop below 50,000/mm3 the first week after receiving 
PF-07209960, then antiplatelet agents should be held during the first week following every 
administration of PF-07209960. All antiplatelet therapy should be held per institutional 
requirements for biopsies and stopped when platelet count is <50,000/mm3 or when active 
bleeding occurs and resume only when platelet count is >50,000/mm3 and there is no 
bleeding. Platelet transfusions should be considered for active bleeding and platelet count 
<50,000/mm3. 
6.5.6. Anti-Diarrheal, Anti-Emetic Therapy 
Primary prophylaxis beyond the first dose is at the investigator’s discretion. The choice of 
the prophylactic drug as well as the duration of treatment is up to the investigator assuming 
there is no known or expected drug-drug interaction and assuming the drug is not listed in the 
Concomitant Therapy section. If irAE of diarrhea or colitis is suspected, please refer to 
Appendix 14 for guidance on the management of irAEs. 
6.5.7. Anti-Inflammatory Therapy 
Anti-inflammatory or narcotic analgesic may be offered as needed assuming there is no 
known or expected drug-drug interaction and assuming the drug is not included in the 
Concomitant Therapy section. 
6.5.8. Corticosteroids 
Chronic systemic corticosteroid use (prednisone >10 mg/day or equivalents) for palliative or 
supportive purposes is not permitted. Acute emergency administration (eg, for prophylaxis 
and/or management of CRS or other toxicities), topical applications, inhaled sprays, eye 
drops, or local injections of corticosteroids are allowed. 
6.5.9. Surgery 
Caution is advised on theoretical grounds for any surgical procedures during the study. The 
appropriate interval of time between surgery and PF-07209960 required to minimize the risk 
of impaired wound healing and bleeding has not been determined. Stopping PF-07209960 is 
recommended at least 7 days prior to surgery. Post-operatively, the decision to reinitiate 
PF-07209960 treatment should be based on a clinical assessment of satisfactory wound 
healing and recovery from surgery. 

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6.5.10. Transfusion Support 
Primary prophylactic use of transfusion support for anemia is allowed to treat anemia, as 
indicated by the current American Society of Clinical Oncology and American Association 
of Blood Banks guidelines (Carson et al, 2016). Primary prophylactic use of transfusion 
support for thrombocytopenia is allowed during screening if the transfusion is completed 
prior to planned study treatment start. Primary prophylactic use of transfusion support for 
thrombocytopenia is allowed to treat thrombocytopenia, as indicated by the current American 
Society of Clinical Oncology (Schiffer et al, 2018). 
6.5.11. Management of Potential Study Intervention-Related Toxicities 
6.5.11.1. Cytokine Release Syndrome 
Symptoms associated with CRS vary greatly and may be difficult to distinguish from other 
conditions. The more common symptoms include fever, nausea, headache, tachycardia, 
hypotension, rash and shortness of breath. The severity of symptoms can be mild to life 
threatening and thus there should be a high suspicion for CRS if these symptoms occur. If 
CRS is suspected, cytokines will be analyzed at central laboratories to determine if cytokine 
elevation consistent with CRS is observed (see Section 8.2.5). The severity of CRS will be 
assessed according to the modified grading described by ASTCT (Lee et al, 2019) and 
captured on the AE CRF and on the CRS CRF as described in Appendix 9. 
CRS should be managed according to the CRS Mitigation and Management guidance in 
Appendix 9 or per local institutional guidelines. 
6.5.11.2. Injection Site Reactions: 
ISR may be immediate, although it usually appears within 24-48 hours after injection. ISR, 
by definition, includes the following: erythema, pruritus, pain, inflammation, rash, 
induration, itching and edema at the injection site. To evaluate ISRs, site tolerability 
assessments will be performed per SoA. 
Topical corticosteroids and topical or systemic antihistamines may be applied to treat any 
rash or pruritis at the injection site. 
6.5.11.3. Hypersensitivity Reactions Types 1 and 3: 
Type 1 hypersensitivity or allergic (eg, shortness of breath, urticaria, anaphylaxis, 
angioedema) reactions are theoretically possible in response to any injected protein. Immune 
complex mediated Type 3 hypersensitivity reactions are similar to the AEs of Type 1 
reactions but are likely to be delayed from the time of injection and may include symptoms 
such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever, and, if severe, 
glomerulonephritis. 
All participants should be closely observed while receiving PF-07209960 injection and 
monitoring will continue thereafter for clinical signs of allergic reactions/hypersensitivity. 

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In the case of a hypersensitivity reaction, the participant will be treated symptomatically with 
supportive care, further monitoring, and treatment with anti-histamines and/or 
corticosteroids. Study intervention may be stopped, and the participant will be followed until 
the end of the study. 
6.5.11.4. Infusion Related Reactions 
IRRs are reactions that occur during or following an infusion of the study intervention. IRRs 
may present with different symptoms and are most commonly characterized by fever and 
chills, and less commonly hypotension or dyspnea. IRRs can typically be distinguished from 
CRS by their timing. IRRs usually occur during administration of the study intervention 
while CRS is delayed until several hours or days after administration of the study 
intervention. In the event of infusion related reactions, investigators should institute 
treatment measures according to best medical and nursing practice. 
Premedication is not required but may be implemented at the investigator’s discretion. If a 
participant experiences an IRR, premedication is recommended prior to subsequent infusions 
(eg, diphenhydramine and acetaminophen) approximately 0.5 to 2 hours before PF-07209960 
administration. This regimen may be modified based on local standards; however, 
corticosteroids are not recommended. The pretreatment medications will not be supplied by 
Pfizer. 
Detailed guidance on treatment, dose interruptions and potential retreatment of IRRs is 
provided in Appendix 15. 
6.5.11.5. Immune-Related Adverse Events 
irAEs are toxicities resulting from the non-specific activation of the immune system that can 
affect almost any organ system. Several irAEs have been described in association with the 
use of ICIs therapies including anti-PD-1, anti-PD-L1 and anti-CTLA-4. The most common 
irAEs described with ICIs are those involving the cutaneous, endocrine, gastrointestinal, 
pulmonary, hepatic and musculoskeletal systems. In addition, less frequent irAEs include 
those involving the cardiovascular, renal, pancreatic, neurological, ophthalmological, and 
hematological systems. In rare cases, irAEs may be life-threatening or lead to death. 
Treatment of irAEs is mainly dependent on severity. In general, Grade 1 or 2 irAEs are 
treated symptomatically with persistent Grade 2, Grade 3 or Grade 4 irAEs managed with 
moderate to high dose corticosteroids and/or hormonal therapy for immune-related 
Guidelines for the treatment of irAEs are provided in Appendix 14. 
6.6. Dose Modification 
Every effort should be made to administer study intervention on the planned dose and 
schedule. In the event of significant toxicity, dosing may be delayed and/or reduced as 
described below. In the event of multiple toxicities, dose modification should be based on the 
worst toxicity observed. Participants are to be instructed to notify investigators at the first 
occurrence of any adverse symptom. 

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In addition to dose modifications, investigators are encouraged to employ best supportive 
care according to local institutional clinical practices. 
Toxicities potentially related to PF-07209960 should be managed according to the dose 
modifications described in Table 4. 
Selected toxicities that do not resolve or worsen following supportive care and dose 
modifications and with a clinical presentation consistent with a potential irAE without a clear 
alternative explanation, may require treatment with corticosteroids or other 
immunosuppressants and should be managed according to the management of irAEs as 
described in Appendix 14. 
CRS should be managed according to the CRS Mitigation and Management guidance as 
described in Appendix 9. 
6.6.1. Dosing Interruptions 
Appropriate follow-up assessments should be done until adequate recovery occurs as 
assessed by the investigator. Doses may be held up to 4 weeks until toxicity resolution. 
Depending on when the AE resolved, a treatment interruption may lead to the participant 
missing one or more of the subsequent planned doses. 
Criteria required before treatment can resume are described in Dose Delays (Section 6.6.2), 
ISR Section 8.2.10), IRRs (Appendix 15) or in the specific toxicity management guidelines 
for CRS (Appendix 9), and irAEs (Appendix 14). 
The need for a dose reduction at the time of treatment resumption should be based on the 
criteria defined in Section 6.6.3, unless expressly agreed otherwise following discussion 
between the investigator and the sponsor. 
In the event of a treatment interruption lasting >4 weeks, treatment resumption will be 
decided in consultation with the sponsor. 
6.6.2. Dose Delays 
Re-treatment following treatment interruption for treatment-related toxicity may not occur 
until all of the following parameters have been met: 
• ANC 1,000/mm3. 
• Platelet count 50,000/mm3 
• Nonhematologic toxicities have returned to baseline or Grade 1 severity (or, at the 
investigator’s discretion, Grade 2 if not considered a safety risk for the participant). 
If a treatment delay results from worsening of hematologic or biochemical parameters, the 
frequency of relevant blood tests should be increased as clinically indicated. 

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If these conditions are met within 4 weeks of treatment interruption, PF-07209960 may be 
resumed. Refer to the Section 6.6.3 for AEs requiring dose reduction at the time of treatment 
resumption. 
If participants require discontinuation of PF-07209960 for more than 4 weeks from last dose 
(2 missed dose) at any time during the study, then study treatment should be permanently 
discontinued, unless the investigator’s benefit/risk assessment suggests otherwise after 
discussion with the sponsor’s medical monitor. 
If a treatment interruption continues beyond Day 28 of the current cycle, then the day when 
treatment is restarted will be counted as Day 1 of the next cycle. 
6.6.3. Dose Reductions 
Following dosing interruption or cycle delay due to toxicity, the PF-07209960 dose may need 
to be reduced when treatment is resumed. 
No specific dose adjustments are recommended for Grade 1/2 treatment-related toxicity. 
However, participants experiencing recurrent and intolerable Grade 2 toxicity may resume 
dosing at the next lower dose level based on investigator’s medical judgment once recovery 
to Grade 1 or baseline is achieved. 
Dose reduction of PF-07209960 by 1 dose level (with maximum reduction to dose level -1, 
0.3 mg SC, 0.06 mg IV) (Table 2) will be allowed depending on the type and severity of 
toxicity encountered. Participants requiring more than 1 dose reduction will be discontinued 
from the treatment and entered into the follow-up phase, unless otherwise agreed between the 
investigator and the sponsor. All dose modifications/adjustments must be clearly documented 
in the participant's source notes and CRF. 
Once a dose has been reduced for a given participant, all subsequent cycles should be 
administered at that reduced dose level, unless further dose reduction is required. 
Intraparticipant dose re-escalation may be allowed after discussion between the investigator 
and sponsor. Participant must not experience a Grade 2 or higher adverse event to be eligible 
for intraparticipant dose re-escalation. 
 
Table 3. 
Available Dose Reduction Levels From Starting Dose 
 
Dose Levela 
SC 
IVb 
Starting 
CCI 
a. PF-07209960 dose de-escalation below -1 dose level is not allowed. 
b. IV infusion over 1 hour (±10 minutes) 
 
Participants experiencing a DLT may resume dosing at the next lower dose level (if 
applicable) once adequate recovery is achieved, and in the opinion of the investigator and 
sponsor, the participant is benefiting from therapy. 

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For management of immune-related adverse events, please refer to Appendix 14. For all 
other toxicities, recommended dose reductions for study intervention are described in 
Table 4. 
 
Table 4. 
Treatment Dose Modifications for Study Intervention-Related Toxicity 
 
Toxicity 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Nonhematologic 
Continue at the 
Continue at the same 
Withhold dose until toxicity Withhold dose until 
same dose level. 
dose level. 
is Grade ≤1, or has returned toxicity is Grade ≤1, or 
to baseline, then resume 
has returned to 
treatment at the same dose 
baseline, then reduce 
level or reduce the dose by 
the dose by 1 level and 
1 level at the discretion of 
resume treatment, or 
the investigator*. 
discontinue at the 
discretion of the 
investigator*. 
Hematologic (except 
Continue at the 
Continue at the same 
Withhold dose until toxicity Withhold dose until 
lymphopenia) 
same dose level. 
dose level. 
is Grade ≤2, or has returned toxicity is Grade ≤2, or 
to baseline, then resume 
has returned to 
treatment at the same dose 
baseline, then reduce 
level**. 
the dose by 1 level and 
resume treatment**. 
* Nausea, vomiting, or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy to require dose modification. 
** Cycle will not be extended to cover for the missing doses. 
 
6.7. Intervention After the End of the Study 
No intervention will be provided per protocol to study participants beyond the end of the 
study. Availability of PF-07209960 following closure of the study through expanded 
access/compassionate/continued use mechanism if the investigator and participant desire to 
continue treatment would be at the discretion of the sponsor and subject to local conditions 
and regulations. 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1. Discontinuation of Study Intervention 
In rare instances, it may be necessary for a participant to permanently discontinue study 
intervention (definitive discontinuation). Reasons for definitive discontinuation of study 
intervention may include the following: 
• 
Objective disease progression; 
• 
Global deterioration of health status requiring discontinuation; 
• 
Unacceptable toxicity; 
• 
Pregnancy; 
• 
Significant protocol violation; 
• 
Lost to follow-up; 

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• 
Participant refused further treatment; 
• 
Study terminated by sponsor; 
• 
Death. 
Note that discontinuation of study intervention does not represent withdrawal from the study. 
If study intervention is definitively discontinued, the participant will remain in the study to 
be evaluated for long-term safety follow-up and survival. See the SoA for data to be collected 
at the time of discontinuation of study intervention and follow-up for any further evaluations 
that need to be completed. 
In the event of discontinuation of study intervention, it must be documented on the 
appropriate CRF/in the medical records whether the participant is discontinuing further 
receipt of study intervention or also from study procedures, posttreatment study follow-up, 
and/or future collection of additional information. 
7.2. Participant Discontinuation/Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request. Reasons for 
discontinuation from the study may include: 
• Completed study follow-up; 
• Study terminated by sponsor; 
• Lost to follow-up; 
• Refused further follow-up; 
• Death. 
At the time of discontinuing from the study, if possible, an early discontinuation visit should 
be conducted. See the SoA for assessments to be collected at the time of study 
discontinuation and follow-up and for any further evaluations that need to be completed. 
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly. 
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations should be performed and no 
additional data should be collected. The sponsor may retain and continue to use any data 
collected before such withdrawal of consent. 
Lack of completion of all or any of the withdrawal/early termination procedures will not be 
viewed as protocol deviations so long as the participant’s safety was preserved. 
7.2.1. Withdrawal of Consent 
Participants who request to discontinue receipt of study intervention will remain in the study 
and must continue to be followed for protocol-specified follow-up procedures. The only 

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exception to this is when a participant specifically withdraws consent for any further contact 
with him or her or persons previously authorized by the participant to provide this 
information. Participants should notify the investigator in writing of the decision to withdraw 
consent from future follow-up, whenever possible. The withdrawal of consent should be 
explained in detail in the medical records by the investigator, as to whether the withdrawal is 
only from further receipt of study intervention or also from study procedures and/or 
posttreatment study follow-up, and entered on the appropriate CRF page. In the event that 
vital status (whether the participant is alive or dead) is being measured, publicly available 
information should be used to determine vital status only as appropriately directed in 
accordance with local law. 
7.3. Lost to Follow-up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for/attend a 
required study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts should be documented 
in the participant’s medical record. 
• Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 
8. STUDY ASSESSMENTS AND PROCEDURES 
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures. 
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed. 
Safety issues should be discussed with the sponsor immediately upon occurrence or 
awareness to determine whether the participant should continue or discontinue study 
intervention. 
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct. 

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All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
Procedures conducted as part of the participant’s routine clinical management (eg, blood 
count) and obtained before signing of the ICD may be utilized for screening or baseline 
purposes provided the procedures met the protocol-specified criteria and were performed 
within the time frame defined in the SoA. 
Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to perform 
the test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner. 
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study. 
8.1. Efficacy Assessments 
8.1.1. Tumor Response Assessments 
Tumor assessments will include all known or suspected disease sites. Imaging will include 
contrast enhanced chest, abdomen and pelvis CT or for participants with known CT contrast 
allergy, a non-contrast CT of the chest with contrast enhanced abdominal and pelvic MRI; 
brain CT or MRI scan for participants with known or suspected brain metastases; bone scan 
and/or bone x-rays for participants with known or suspected bone metastases. CT/MRI 
imaging of other areas of tumor involvement not listed above should also be reported. The 
same imaging technique used to characterize each identified and reported lesion at baseline 
will be employed in the following tumor assessments. It is important to use the same 
technique, especially if using non-contrast computed tomography of the chest and MRI of 
abdomen and pelvis for those with contrast allergy. 
Anti-tumor activity will be assessed through radiological tumor assessments conducted at 
baseline, during treatment as specified in the SoA, whenever disease progression is suspected 
(eg, symptomatic deterioration), and at the time of withdrawal from treatment (if not done in 
the previous 6 weeks). Assessment of response will be made using RECIST version 1.1 
(Appendix 11). Tumor response assessment will be performed locally. 
All participants’ files and radiologic images must be available for source verification and for 
potential peer review. 

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For Part 2 Dose Expansion, radiologic images will be submitted to an imaging laboratory for 
the purpose of holding for possible future central review if deemed necessary. In the event 
that central review is conducted, it would not be a complete medical review of participant 
and no incidental findings will be shared with the PI, site staff, or participant. All safety 
reviews will be the sole responsibility of the site staff. 
Detailed information regarding the submission of images to the core laboratory is found in 
the Imaging Manual. 
8.2. Safety Assessments 
Planned time points for all safety assessments are provided in the SoA. Unscheduled clinical 
laboratory measurements may be obtained at any time during the study to assess any 
perceived safety issues. 
Safety assessments will include collection of AEs, SAEs, vital signs and physical 
examination, ECG (12-lead), laboratory assessments, including pregnancy tests and 
verification of concomitant treatments. 
8.2.1. Physical Examinations 
Participants will have a physical examination to include weight, assessment of ECOG 
performance status and height; height will be measured at baseline only. 
A complete physical examination will include, at a minimum, assessments of the eyes, ears, 
nose, throat, heart, lungs, abdomen, skin, and neurologic system. 
A brief physical examination will include, at a minimum, assessments of the heart, lungs, and 
abdomen including skin at injection sites. 
Investigators should pay special attention to clinical signs related to previous serious 
illnesses. 
8.2.2. Vital Signs 
Temperature (oral preferred), heart rate, and BP will be assessed. 
Blood pressure and heart rate measurements will be assessed in the sitting or semi-supine 
position with a completely automated device. Manual techniques will be used only if an 
automated device is not available. 
Blood pressure and heart rate measurements should be preceded by at least 5 minutes of rest 
for the participant. 
Vital signs (to be taken before blood collection for laboratory tests) will consist of 1 heart 
rate and 3 blood pressure measurements (during screening). The average of the 3 blood 
pressure readings will be recorded on the CRF. 

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8.2.3. Electrocardiograms 
Standard 12-lead ECGs utilizing limb leads (with a 10-second rhythm strip) should be 
collected at times specified in the SoA section of this protocol using an ECG machine that 
automatically calculates the heart rate and measures PR, QT, and QTcF intervals and QRS 
complex. Alternative lead placement methodology using torso leads (eg, Mason-Likar) is not 
recommended given the potential risk of discrepancies with ECGs acquired using standard 
limb lead placement. All scheduled ECGs should be performed after the participant has 
rested quietly for at least 10 minutes in a supine position. 
At each time point (see the schedule of activities), 3 consecutive ECGs will be performed at 
approximately 1-4 minutes apart to determine the mean QTcF interval. To ensure safety of 
the participants, a qualified individual at the investigator site will make comparisons to 
baseline measurements. Additional ECG monitoring will occur if a) the mean value from the 
triplicate measurements for any postdose QTcF interval is increased by 60 msec from the 
baseline and is >450 msec; or b) an absolute QTcF value is 500 msec for any scheduled 
ECG. If either of these conditions occurs, then a single ECG measurement must be repeated 
at least hourly until QTcF values from 2 successive ECGs fall below the threshold value that 
triggered the repeat measurement. In addition, if verified QTcF values continue to exceed the 
criteria above, immediate correction for reversible causes including electrolyte abnormalities, 
hypoxia and concomitant medications for drugs with the potential to prolong the QTcF 
interval should be performed. Consultation with a cardiologist will be performed if clinically 
warranted or if the QTcF value is >500 msec for any scheduled ECG. 
If the QTcF interval reverts to less than the threshold criteria listed above, and in the 
judgment of the investigator(s) and sponsor, it is determined that the cause(s) of QTcF 
prolongation is something other than study intervention, treatment may be continued with 
regular ECG monitoring. If in that timeframe the QTcF intervals rise above the threshold 
values, the study intervention will be held until the QTcF interval decreases to below the 
threshold values. Participants will then restart the study intervention at the next lowest dose 
level. If the QTcF interval has still not decreased to 480 msec after 2 weeks, or if at any time 
a participant has a QTcF interval >515 msec attributed to study treatment or becomes 
symptomatic due to QTcF changes, the participant will be removed from the study. 
Additional triplicate ECGs may be performed as clinically indicated. 
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality. It is important that leads be placed in the 
same positions each time in order to achieve precise ECG recordings. If a machine-read 
QTcF value is prolonged, as defined above, repeat measurements may not be necessary if a 
qualified medical provider’s interpretation determines that the QTcF values are in the 
acceptable range. 
If a participant experiences a cardiac or neurologic AE (specifically syncope, dizziness, 
seizures, or stroke), an ECG (triplicate) should be obtained at the time of the event. 
ECG values of potential clinical concern are listed in Appendix 7. 

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8.2.4. Echocardiogram or MUGA 
Participants must be in supine position in a rested and calm state for at least 5 minutes before 
LVEF assessment is conducted. If the participant is unable to be in the supine position, the 
participant should be in the most recumbent position possible. 
The investigator or designated site physician will review all echocardiograms. Once signed, 
the original echocardiogram will be retained with the participant’s source documents. At the 
request of the sponsor, a copy of the original echocardiogram will be made available to 
Pfizer. Standard echocardiogram machines should be used for all study-related 
echocardiogram requirements. 
Echocardiograms or MUGAs (preferred) will be measured at time points specified in the 
SoA or if clinically warranted. Imaging method must be consistent throughout the study for 
individual participants. 
8.2.5. Clinical Safety Laboratory Assessments 
See Appendix 2 for the list of clinical safety laboratory tests to be performed and the SoA for 
the timing and frequency. All protocol required laboratory assessments, as defined in 
Appendix 2, must be conducted in accordance with the laboratory manual and the SoA. 
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety issues. 
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF. 
Clinically significant abnormal laboratory findings are those which are not associated with 
the underlying disease, unless judged by the investigator to be more severe than expected for 
the participant's condition. 
All laboratory tests with values considered clinically significantly abnormal during 
participation in the study or within 28 days after the last dose of study intervention should be 
repeated until the values return to normal or baseline or are no longer considered clinically 
significant by the investigator or medical monitor. 
If such values do not return to normal/baseline within a period of time judged reasonable by 
the investigator, the etiology should be identified, and the sponsor notified. 
See Appendix 6 for suggested actions and follow-up assessments in the event of potential 
drug-induced liver injury. 
8.2.6. Safety Imaging Assessments 
Not applicable. Refer to Section 8.1.1 for efficacy imaging. 
8.2.7. Pregnancy Testing 
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least 
25 mIU/mL. Pregnancy tests will be performed in WOCBP at the times listed in the SoA. 
Following a negative pregnancy test result at screening, appropriate contraception must be 

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commenced, and a second negative pregnancy test result will be required at the baseline visit 
prior to the participant’s receiving the study intervention. Pregnancy tests will also be done 
whenever 1 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 (eg, an ambiguous result), a serum pregnancy test is required. In such 
cases, the participant must be excluded if the serum pregnancy result is positive. 
8.2.8. Fertility Perservation 
Male particpants planning to have children in the future should consider banking their sperm 
prior to starting the study. These discussions must take place prior to enrollment as sperm 
donations during or after the study are not recommended. Highly effective contraceptive 
precautions should be used to prevent pregnancy when either partner is receiving PF- 
07209960 as described in Appendix 4. 
8.2.9. Inpatient Monitoring 
Participants receiving PF-07209960 will be monitored (per local standard of practice) during 
and following their first dose with a 72-hour inpatient hospitalization period. This will be 
implemented throughout dose escalation, and length of inpatient hospitalization will be 
re-assessed based on safety data prior to starting dose expansion cohorts. Participants should 
remain at the investigational site for observation for at least 1-hour post dose for all treatment 
visits after C1D1. For C1D15 PF-07209960 IV administration, participants should remain at 
the investigational site for observation for at least 8-hours post dose. Participants may not be 
released until the investigator has confirmed the participant has not exhibited signs and 
symptoms of a cytokine reaction. Actual observation times for second and subsequent doses 
may be lengthened depending on clinical experience during hospitalization for previous 
doses. Participants may be released only after the investigator has confirmed the participant 
has sufficiently recovered from any CRS. Hospitalization period may be extended if the 
participant experiences abnormal laboratory findings or ongoing AEs that require further 
hospitalization. Participants should complete the required study specific laboratory 
assessments as detailed in the SoA and monitored per local standard practice for inpatient 
monitoring. 
Record AEs (AEs consist of nonserious AEs and SAEs) as described in Appendix 3. 
Refer to Appendix 9 for CRS Mitigation and Management guidance. 
8.2.10. Local Site Injection Tolerability Assessment (SC Only) 
Assessments of the injection sites in the abdominal fat fold to monitor local tolerability to 
PF-07209960 SC injections will be performed at least 1 hour following treatment 
administration in Cycle 1, and performed daily during hospitalization for first dose or until 
no skin changes are seen at injection site, whichever comes first as per the SoA. If SC 
injections in the abdominal location are not possible, SC injections can be administered in a 
distributed manner in the thighs. SC injections in the upper extremities (eg, deltoid, upper 
and lower arm) are not permitted. Refer to Appendix 12 for more details. 

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Site tolerability assessments should continue at regularly scheduled visits if injection site 
pain or ISR characteristics continue to persist after the first cycle. The assessments should 
continue until the symptoms resolve. The injection sites will be assessed for erythema, 
induration, ecchymosis, injection site pain, injection site pruritus, or other observed 
characteristics after study drug dosing. The diameter of the affected area will be measured, 
and the condition of the injection site will be recorded on the SC Injection Site Assessment 
CRF. Any observed abnormality at the injection site will be judged by the investigator to 
determine whether a corresponding AE should be reported. ISRs should be immediately 
photographed in color, with scaled ruler placed by the reaction, and these photographs should 
be included in the participant’s source documentation. Deidentified photographs of the 
affected area may be requested by the sponsor to further understand the extent of skin 
toxicity. When appropriate, at the discretion of the investigator, a participant with an ISR 
may be referred for a dermatological consultation and skin biopsy may be obtained for future 
examination of the ISR. The dermatology consultation is expected to take place at the 
dermatologist’s practice location, or may occur within the same institution where this study is 
conducted. 
Please refer to the laboratory manual. 
Record AEs as described in Appendix 3. 
8.2.11. One-Month Follow-up Visit 
For follow-up procedures see SoA and Section 8. 
At least 28 calendar days and no more than 35 calendar days, after discontinuation of study 
intervention, participants will return to undergo the assessments outlined in the SoA as well 
as a review of concomitant treatments, vital signs, and assessment for resolution of any 
treatment related AEs. Participants continuing to experience toxicity at this point following 
discontinuation of treatment will continue to be followed at least every 28 days until 
resolution or determination, in the clinical judgment of the investigator, that no further 
improvement is expected. 
In the event a participant is unable to return to the clinic for the follow-up visit, telephone 
contact with the participant to assess AEs and concomitant medications and treatment is 
expected. If laboratory assessments are needed to follow-up unresolved AEs, retrieval of 
assessments performed at an institution local to the participant is acceptable. 
8.2.12. Survival Follow-up 
Subsequent to the 1-month follow-up visit, participants survival status will be collected by 
telephone every 8 weeks (±7 days) to obtain information on subsequent anti-cancer treatment 
and overall survival until the end of the study. If the participant is seen in the clinic during 
the window of time that a scheduled telephone call is to be made to collect survival data, then 
the clinic visit may replace the survival telephone call. Any SOC tumor response assessments 
including CT/MRI imaging CCI 
 obtained 
between EOT and subsequent anti-cancer therapy will also be collected. 

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8.3. Adverse Events and Serious Adverse Events 
The definitions of an AE and an SAE can be found in Appendix 3. 
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or 
the participant's legally authorized representative). 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study intervention (see Section 7.1). 
Each participant/legally authorized representative will be questioned about the occurrence of 
AEs in a nonleading manner. In addition, the investigator may be requested by Pfizer Safety 
to obtain specific follow-up information in an expedited fashion. 
8.3.1. 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 the participant’s participation in the study (ie, before undergoing 
any study-related procedure and/or receiving study intervention), through and including a 
minimum of 90 calendar days, except as indicated below, after the last administration of the 
study intervention. 
During the long-term follow-up period in this study for survival, only SAEs will be actively 
elicited and collected after completion of the active collection period described above. The 
SAEs identified during long-term follow-up will be reported to Pfizer Safety on the CT SAE 
Report Form only if considered reasonably related to the study intervention. 
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 and Pfizer concurs with that assessment. 
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 definitively 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 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 he/she considers the event 

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to be reasonably related to the study intervention, the investigator must promptly report the 
SAE to Pfizer using the CT SAE Report Form. 
8.3.1.1. Reporting SAEs to Pfizer Safety 
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the CT SAE Report Form immediately upon 
awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 3. The investigator will submit any updated SAE data to the sponsor within 
24 hours of it being available. 
If a participant begins a new anticancer therapy, SAEs occurring during the above-indicated 
active collection period must still be reported to Pfizer Safety irrespective of any intervening 
treatment. Note that a switch to a commercially available version of the study intervention is 
considered as a new anticancer therapy for purposes of SAE reporting. Recording Nonserious 
AEs and SAEs on the CRF 
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF. 
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant. 
If a participant begins a new anticancer 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 anticancer 
therapy for the purposes of SAE reporting. 
8.3.2. Method of Detecting AEs and SAEs 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences. 
8.3.3. Follow-up of AEs and SAEs 
After the initial AE/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 (as defined in Section 7.3). 
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 

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possible causality. Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is given in Appendix 3. 
8.3.4. 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 towards 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 
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. 
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure 
Exposure to the study intervention under study during pregnancy or breastfeeding and 
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator 
awareness. 
8.3.5.1. Exposure During Pregnancy 
An EDP occurs if: 
• A female is found to be pregnant while being exposed or having been exposed to 
study intervention due to environmental exposure. Below are examples of 
environmental exposure during pregnancy: 
o A female family member or healthcare provider reports that she is pregnant 
after having been exposed to the study intervention by accidental injection or 
contact of study intervention with mucous membranes or open wounds. 
o A male family member or healthcare provider who has been exposed to the 
study intervention by accidental injection or contact of study intervention with 
mucous membranes or open wounds then exposes 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 

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should include the anticipated date of delivery (see below for information related to 
termination of pregnancy). 
• If EDP occurs in a participant or a participant’s partner, the investigator must report 
this information to Pfizer Safety 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 and until 4 months 
after the last dose. 
• If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety 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 
preprocedure 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; 
• 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. 
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 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. 

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8.3.5.2. Exposure During Breastfeeding 
An exposure during breastfeeding occurs if: 
• A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention. 
• A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure). An example of environmental 
exposure during breastfeeding is a female family member or healthcare provider who 
reports that she is breastfeeding after having been exposed to the study intervention 
by inhalation or skin contact. 
The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours 
of the investigator’s awareness, irrespective of whether an SAE has occurred. The 
information must be reported using the CT SAE Report Form. When exposure during 
breastfeeding 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 is maintained in the 
investigator site file. 
An exposure during breastfeeding report is not created when a Pfizer drug specifically 
approved for use in breastfeeding women (eg, vitamins) is administered in accord with 
authorized use. However, if the infant experiences an SAE associated with such a drug, the 
SAE is reported together with the exposure during breastfeeding. 
8.3.5.3. Occupational Exposure 
An occupational exposure occurs when a person receives unplanned direct contact with the 
study intervention, which may or may not lead to the occurrence of an AE. Such persons may 
include healthcare providers, family members, and other roles that are involved in the trial 
participant’s care. 
The investigator must report occupational exposure to Pfizer Safety within 24 hours of the 
investigator’s awareness regardless of whether there is an associated SAE. The information 
must be reported using the CT SAE Report Form. Since the information 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 is maintained in the investigator site file. 
8.3.6. Cardiovascular and Death Events 
Not Applicable 
8.3.7. Disease Related Events and/or Disease Related Outcomes Not Qualifying as AEs 
or SAEs 
Not applicable. 

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8.3.8. Adverse Events of Special Interest 
CRS, thrombocytopenia (including bleeding), abnormal liver function, abnormal renal 
function, irAEs (including myocarditis) and ISRs will be monitored as AEs of special 
interest. 
CRS and associated symptoms should be recorded within the CRF for CRS, and the overall 
CRS term should be recorded as an AE or SAE on the CRF as well using ASTCT grading 
scale. Any CRS-associated symptoms do not need to be duplicated within the AE or SAE 
CRFs. 
Information regarding ISRs should be recorded within the injection site assessment CRF. If 
any ISRs are considered AEs or SAEs, they should also be graded by CTCAE v5.0 and 
reported within the AE CRF. 
All AESIs must be reported as an AE or SAE following the procedures described in 
Sections 8.3.1 through 8.3.4. An AESI is to be recorded as an AE or SAE on the CRF. In 
addition, an AESI that is also an SAE must be reported using the CT SAE Report Form. 
8.3.8.1. Lack of Efficacy 
Lack of efficacy (see Appendix 3, Section 10.3.1) is reportable to Pfizer Safety only if 
associated with an SAE. 
8.3.9. Medical Device Deficiencies 
Not applicable. 
8.3.10. Medication Errors 
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. 
 
Safety Event 
Recorded on the CRF 
Reported on the CT SAE Report 
Form to Pfizer Safety Within 24 
Hours of Awareness 
Medication errors 
All (regardless of whether 
associated with an AE) 
Only if associated with an SAE 
 
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. 
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page. 

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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 is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF. 
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE. 
Other examples include, but are not limited to: 
• 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. 
8.4. Treatment of Overdose 
For this study, any dose of PF-07209960 greater than 50% of the assigned dose level for the 
participant within a 24-hour time period will be considered an overdose, unless this dose 
level has been declared as safe in the dose escalation phase. 
Sponsor does not recommend specific treatment for an overdose. 
In the event of an overdose, the investigator/treating physician should: 
1. Contact the medical monitor within 24 hours. 
2. Closely monitor the participant for any AEs/SAEs and laboratory abnormalities for at 
least 5 half-lives or 28 calendar days after the overdose of PF-07209960 (whichever 
is longer). 
3. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF. 
4. Overdose is reportable to Safety only when associated with an SAE. 
5. Obtain a blood sample for PK analysis within 2 weeks from the date of the last dose 
of study intervention if requested by the medical monitor (determined on a 
case-by-case basis). 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant. 

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8.5. Pharmacokinetics 
8.5.1. Analysis of PF-07209960 
Blood samples will be collected for measurement of serum concentrations of PF-07209960 
as specified in the SoA. Instructions for the collection and handling of biological samples 
will be provided in the laboratory manual or by the sponsor. The actual date and time 
(24-hour clock time) of each sample will be recorded. 
For IV administration only, the EOI (the infusion duration includes the flush duration if 
implemented) samples should be collected from the contralateral arm of PF-07209960 
infusion. 
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 of the collection is noted on the 
source document and the CRF/DCT. If a scheduled blood sample collection cannot be 
completed for any reason, the missed sample time may be re-scheduled with agreement of 
the clinical investigator, participant, and sponsor. 
Samples collected for analyses of PF-07209960 serum concentration may also be used to 
evaluate safety or efficacy aspects related to concerns arising during or after the study, for 
evaluation of the bioanalytical method, or for other internal exploratory purposes. Any such 
data generated will not be included in the CSR. 
Genetic analyses will not be performed on these samples unless consent for this was included 
in the informed consent. Participant confidentiality will be maintained. 
Samples collected for measurement of serum concentrations of PF-07209960 will be 
analyzed using a validated analytical method in compliance with applicable SOPs. 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. 
Any changes in the timing or addition of time points for any planned study assessments must 
be documented and approved by the relevant study team member and then archived in the 
sponsor and site study files, but will not constitute a protocol amendment. The IRB/EC will 
be informed of any safety issues that require alteration of the safety monitoring scheme or 
amendment of the ICD. 
8.6. Pharmacodynamics 
PD will be evaluated in this study. See Section 8.8 Biomarkers. 

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■ 
8.7. Genetics 
8.7.1. Specified Genetics 
Genetics (specified analyses) are not evaluated in this study. 
8.7.2. Banked Biospecimens for Genetics 
A 4-mL blood sample optimized for DNA isolation (Prep D1) will be collected as local 
regulations and IRBs/ECs allow. 
Banked Biospecimens may be used for research related to the study intervention(s) and 
cancer. Genes and other analytes (eg, proteins, RNA, nondrng metabolites) may be studied 
using the banked samples. 
See Appendix 5 for info1mation regarding genetic research. Details on processes for 
collection and shipment of these samples can be found in the laborato1y manual. 
8.8. Biomarkers 
Biospecimens collected for phaimacodynamic and other biomarker assessments will include 
peripheral blood, and tumor tissues which will be used to analyze DNA, RNA, and proteins, 
for achieving planned biomai·ker objectives. Refer to the SoA for sample collection time 
points and Study/Laborato1y Manual for sample processing and shipping. The following 
biospecimen types are planned to be collected in suppo1t of study objectives. Additional 
biospecimens collected over the course of pa1ticipant disease management may be submitted 
for biomai·ker analyses. 
8.8.1. Archival/De Novo Tumor Biopsies 
Tumor biospecimens from ai·chival FFPE or de novo biopsies will be used to analyze 
candidate nucleic acid and protein biomai·kers for their ability to identify those paiticipants 
who ai·e most likely to benefit from treatment with the study diugs. Biomai·kers may include, 
but ai·e not limited to tai·get expression, nucleic acid analyses, as well as cell types and 
constituents of the TME. De Novo tumor biopsies obtained upon disease progression may be 
used to investi ate  hannacod 
amic activities mode of action and ac uired mechanisms of 
 
. Additional info1mation 
on tissue collection procedures can be found in the Laborato1y/Study Manual. 
Pre-treatment ai·chival FFPE material containing tumor that is of diagnostic quality and 
representative of the diagnosed malignancy collected :SI yeai· prior to study strut is required 
of all paiticipants, and if not available, a pre-treatment de novo (fresh) tumor biopsy will be 
required. If the ai·chived sample is older than 1 yeai·and a biopsy during screening cannot be 
perfo1med, the investigator must contact the sponsor to discuss eligibility prior to emollment. 
For 10-15 aitici ants er cohort in Pait 2, a de novo tumor biopsy at pre-treatment 
will be required. An ai·chival sample collected prior to study 
strut may not be substituted for the mandato1y pre-treatment paired biopsy in Pait 2 dose 

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expansion. For all other paiiicipants, 
 biopsy is optional but 
highly encouraged. However, if paiiicipants agree to provide fresh on-ti·eatment tumor 
biopsies then they will also need to provide fresh pre-ti·eatment tumor biopsies as paired 
samples. Tumor paired biopsies should preferably be taken from the same lesion and from a 
lesion that has not been previously inadiated. Tumor tissue from cytologic sampling (eg, fine 
needle aspiration, including FFPE cell pellet material) or bone specimen, is not adequate and 
should not be submitted. 
Paiiicipants should not be subjected to a significant risk procedure to obtain the biopsies (ie, 
the absolute risk of mortality or major morbidity in the participant's clinical setting and at the 
institution completing the procedure should be <2%). 
Additional infonnation on tissue collection procedures can be found in the Laborato1y 
Manual. 
8.8.2. Whole Blood, Plasma, Serum 
 
sequencing to detect gennline mutations to serve as a nonnal conti·ol for detecting somatic 
mutations. Additional analyses may be waiTanted based on emerging data. Should the site 
require cytokine info1mation for participant management such as in the case of suspected 
CRS, the site should collect an additional blood sample for local analysis. 
 
 
in the SoA. Instmctions for sample collection, processing, storage 
shipment and detailed panels of cytokine/chemokine and immunophenotyping markers will 
be provided in the laborato1y manual. 
8.9. Immunogenicity Assessments 
Blood samples will be collected for dete1mination of ADA and NAb as specified in the SoA. 
Instructions for the collection and handling of biological samples will be provided in the 
laborato1y manual or by the sponsor. The actual date and time (24-hour clock time) of each 
sample will be recorded. 
Samples collected for detennination of ADA and NAb may also be used for additional 
chai·acterization of the immune response and/or evaluation of the bioanalytical method, or for 
other internal explorato1y pmposes. These data will be used for internal explorato1y pmposes 
and not repo1ied in CSR. 

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Genetic analyses will not be performed on these samples. Participant confidentiality will be 
maintained. 
Samples 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 
neutralization activity. 
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. 
Any changes in the timing or addition of time points for any planned study assessments must 
be documented and approved by the relevant study team member and then archived in the 
sponsor and site study files, but will not constitute a protocol amendment. The IRB/EC will 
be informed of any safety issues that require alteration of the safety monitoring scheme or 
amendment of the ICD. 
8.10. Health Economics 
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study. 
9. STATISTICAL CONSIDERATIONS 
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in the SAP, which will be maintained by the sponsor. 
The SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment. 
The data will be summarized with respect to demographic and baseline characteristics, 
efficacy observations and measurements, safety observations and measurements, 
pharmacokinetic and biomarker measurements. 
9.1. Statistical Hypotheses 
There is no formal hypothesis testing in this study. 
9.2. Sample Size Determination 
The total number of participants is estimated to be approximately 74-172 enrolled to study 
intervention. 
9.2.1. Part 1: Dose Escalation 
Approximately 14-22 participants are expected to be enrolled in Part 1 dose escalation. The 
total number of participants will depend on the number of dose levels needed to determine 

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the MTD/RP2D and the actual number of participants evaluable for DLT at each dose level. 
In general, each cohort in the dose escalation part will be approximately 2-4 participants. For 
the dose level that is estimated to be the MTD, a minimum of 6 evaluable participants will be 
treated at this dose. 
9.2.2. Part 2: Dose Expansion 
Each cohort in Part 2 will enroll 20-30 participants. Approximately 60-90 participants will be 
initially enrolled in the first three cohorts, with the option to further enroll approximately 40- 
60 participants in an additional two cohorts. 
Clinical response will be continuously monitored in each expansion cohort and if no clinical 
benefit is observed enrollment may be stopped for the respective cohort. 
A Beta-Binomial model, using a non-informative prior (ie, Jeffery’s prior), was used to 
estimate the posterior probability that the true ORR is ≤10%, 20%, or 30% based on an 
observed ORR. Enrollment of participants into a given cohort may be discontinued if 
minimal or no anti-tumor activity (eg, 0 or 1 response) is observed in the first 10 evaluable 
participants. For example, if 1 out of 10 participants have tumor response, this would 
translate into a posterior probability equal to 0.77 that the true response is inferior to 20%. 
Alternatively, if 5 out of 20 participants have tumor response, this would translate into a 
posterior probability equal to 0.725 that the true response is not inferior to 20%. The results 
for observed response rates ranging from 20-40% with 20 or 30 participants per expansion 
cohort are provided in Table 5. Posterior probabilities may be calculated by using 
informative priors based on the anti-tumor activity that may be observed during dose 
escalation. These posterior probabilities will be assessed for each indication during Part 2 
when at least 10 participants have been enrolled in a given indication/subgroup. 
 
Table 5. 
Posterior Probability that the true ORR (θ) is above or below some 
threshold, for a given observed ORR. 
 
Observed ORR 
P(θ ≤ 10%|data) 
P(θ > 20%|data) 
P(θ > 30%|data) 
4/20 (20%) 
0.078 
0.523 
0.165 
5/20 (25%) 
0.023 
0.725 
0.323 
6/20 (30%) 
0.005 
0.866 
0.513 
7/20 (35%) 
0.001 
0.946 
0.696 
8/20 (40%) 
0 
0.982 
0.836 
6/30 (20%) 
0.044 
0.519 
0.113 
7/30 (23%) 
0.014 
0.689 
0.216 

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Table 5. 
Posterior Probability that the true ORR (θ) is above or below some 
threshold, for a given observed ORR. 
 
Observed ORR 
P(θ ≤ 10%|data) 
P(θ > 20%|data) 
P(θ > 30%|data) 
8/30 (27%) 
0.004 
0.822 
0.354 
9/30 (30%) 
0.001 
0.91 
0.511 
10/30 (33%) 
0 
0.96 
0.663 
11/30 (37%) 
0 
0.984 
0.79 
12/30 (40%) 
0 
0.994 
0.882 
 
9.3. Analysis Sets 
1. Full analysis set. 
The full analysis set includes all enrolled participants. 
"Enrolled" means a participant's, or their legally authorized representative’s, 
agreement to participate in a clinical study following completion of the informed 
consent process. Potential participants who are screened for the purpose of 
determining eligibility for the study, but do not participate in the study, are not 
considered enrolled, unless otherwise specified by the protocol. 
2. Safety analysis set. 
The safety analysis set includes all enrolled participants who receive at least one dose 
of study intervention. Unless otherwise specified, the safety analysis set will be the 
default analysis set used for all analyses. 
3. Per protocol analysis set (evaluable for MTD). 
The per protocol analysis set includes all enrolled and evaluable participants who had 
at least one dose of study treatment and either experienced DLT or do not have major 
treatment deviations during the DLT observation period. 
4. mITT Population. 
The mITT is the analysis population that will follow the ITT principle and include 
participants receiving at least 1 dose of study medication with baseline assessment 
and at least 1 post baseline assessment, disease progression, or death before the first 
tumor assessment. The mITT population may be used for interim analysis and 
conference presentations when the study is still ongoing. 

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5. PK analysis sets. 
The PK parameter analysis population is defined as all enrolled participants treated 
who do not have protocol deviations influencing PK assessment, and have sufficient 
information to estimate at least 1 of the PK parameters of interest. 
The PK concentration population is defined as all enrolled participants who are 
treated and have at least 1 postdose analyte concentration. 
6. Response Evaluable Set. 
The response evaluable population will include all participants who received at least 
one dose of study treatment and had baseline disease assessment and at least one post 
baseline disease assessment. 
7. PD/Biomarker analysis set(s). 
The PD/Biomarker analysis population is defined as all enrolled participants with at 
least 1 of the PD/Biomarkers evaluated at pre and/or post dose. 
8. Immunogenicity analysis set. 
The immunogenicity analysis set includes all enrolled participants who receive at 
least one dose of study treatment and have at least one sample tested for ADA. 
9.4. Statistical Analyses 
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data. 
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints. 
Unless otherwise specified, summaries will be presented by dose group and overall. 
Descriptive statistics, such as the mean, standard deviation, coefficient of variation, median, 
minimum, and maximum values, will be provided for continuous endpoints. The rates of 
binary endpoints will be provided along with the corresponding 2-sided 95% confidence 
intervals using an exact method. Time-to-event endpoints will be summarized using the 
Kaplan-Meier method and displayed graphically when appropriate. Median event times and 
2-sided 95% confidence intervals for each time-to-event endpoint will be provided. 
9.4.1. Maximum Tolerated Dose Determination 
Determination of MTD will be performed using per protocol analysis set (evaluable for 
MTD). 
Bayesian adaptive approach: 
The dose escalation in the Part 1 of the study will be guided by a Bayesian analysis of DLT 
data for PF-07209960. Dose toxicity is modelled using two-parameter logistic regression for 
the probability of a participant experiencing a DLT at the given dose. 

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Assessment of Participant Risk: 
After each cohort of participants, the posterior distribution for the risk of DLT for new 
participants at different doses of interest for PF-07209960 will be evaluated. The posterior 
distributions will be summarized to provide the posterior probability that the risk of DLT lies 
within the following intervals: 
 
Under-dosing 
[0, 0.16] 
Targeted dosing 
[0.16, 0.33] 
Overdosing 
[0.33, 1] 
 
The EWOC principle: 
Dosing decisions are guided by the escalation with overdose control principal (Rogatko et al, 
2007). A dose may only be used for newly enrolled participants if the probability of 
overdosing at that dose is CCI 
. 
Recommendation from the BLRM, along with safety (AEs, SAEs), laboratory, PK, 
biomarker and other relevant data, will be used at the time of each dose escalation and for 
MTD/RP2D determination. 
Prior distributions: 
Weakly informative prior distributions based on pre-clinical/expert opinion information will 
be chosen for the logistic parameters, see Appendix 8. 
Starting dose: 
The starting dose is CCI 
 in Part 1 Dose Escalation. For this dose the prior risk of 
overdosing satisfies the EWOC criterion. 
9.4.1.1. Stopping Criteria 
The dose escalation will be stopped when the following criteria are met: 
• At least 6 participants have been treated at the recommended MTD/RP2D. 
• The dose d~ satisfies 1 of the following conditions: 
• The probability (π) of target toxicity at dose d~ exceeds 
50%, ie, Pr(0.16 ≤ rrd- <0.33) ≥50%. 
• A minimum of 15 participants have been treated in the trial. 
In case all doses explored appear to be overly toxic and the MTD cannot be determined, the 
dose escalation will stop. 
In case of change of the dosing regimen, DLT data accumulated during the dose escalation 
with the original regimen might be used to form a MAP prior for further BLRM analysis. 
MAP priors are derived from hierarchical models, which take into account possible 

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differences between the studies. Details of priors and general description of MAP approach is 
presented in Appendix 8 and a statistical technical supplement. 
To mitigate the risk of misclassifying DLTs, a sensitivity that uses weighted DLT/AE data 
(in equivocal cases) within the BLRM will be performed. If all investigators and the sponsor 
agree on the equivocal DLT/AE data, the DLT weighting approach could be the primary dose 
escalation method (see Appendix 8). 
9.4.2. Efficacy Analysis 
Response Evaluable Set will be used for all response related analyses including ORR, DCR, 
DOR, PFS, and TTP, and OS. 
Tumor response will be presented in the form of participant data listings that include, but are 
not limited to tumor type, dose on Day 1, tumor response at each visit. In addition, 
progression date, death date, date of first response and last assessment date, and date of last 
contact will be listed. A summary of tumor response based on RECIST 1.1 will also be 
presented. 
Progression date, date of first response, last tumor assessment date, date of last contact, and 
death date will be listed. 
The Kaplan-Meier methods will be used to analyze all time to event efficacy endpoints. The 
efficacy endpoints that will be analyzed in this study are defined as follows: 
• ORR is defined as the percentage of participants with a BOR of CR or PR. 
• DCR is defined as the percentage of participants with a BOR of CR, PR, non-CR/non PD 
or SD. 
• DOR is defined as the time from first documentation of CR or PR to date of first 
documentation of PD or death due to any cause, whichever occurs first. 
• PFS is defined as time from start date of treatment to the date of first documentation of 
PD or death due to any cause. 
• TTP is defined as the time from start date of treatment to the date of the first 
documentation of PD. 
• OS is defined as the time from start date of treatment to the date of death due to any 
cause. 
The detailed analyses will be described in the SAP. The definition of each response category 
is provided in Appendix 11. 

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9.4.3. Pharmacokinetic Analysis 
9.4.3.1. Single-Dose and Steady-State PF-07209960 Pharmacokinetic Analysis 
Sernm concentrations of PF-07209960 will be summarized descriptively (n, mean, standard 
deviation, coefficient of variation, median, minimum, maximum, geometric mean and its 
associated coefficient of variation) by dose, cycle, day and nominal time. Median profiles of 
the concentrntion-time profiles after CIDI dose and C2D15 dose will be plotted separately 
by dosing coho1i and cycle using nominal times for Pa1i 1 only. Median profiles will be 
presented on both linear-linear and log-linear scales. 
Individual participant semm concentration-time data within a dose interval after CIDI and 
C2D15 will be analyzed using noncompartmental methods to detennine single- and 
multiple- dose PK parameters. Single-dose PK parameters to be estimated will include the 
Cmax, Tmax, and AUC from time Oto AUC1ast, and if data pennit, AUC from time 0 
extrapolated to AUCnr, t112, apparent oral CI.JF, and VJF. Multiple-dose PK parameters to be 
estimated will include Cmax,ss, Tmax.ss, AUCtau.ss, sennn Ctrough.ss, CLsJF, and if data permit, 
Vz,ss!F, t112,ss, and Rae. The single dose and steady state PK parameters will be summarized 
descriptively (n, mean, standard deviation, coefficient of variation, median, minimum, 
maximum, geometric mean and its associated coefficient of variation) by dose level, cycle 
and day. 
Dose nonnalized AUCinf (AUCtau,ss), AUC1ast and Cmax will be plotted against dose (using a 
logarithmic scale) by cycle and day. These plots will include individual paiiicipant values 
and the geometric means for each dose. 
9.4.4. Analysis of Immunogenicity Data 
For the immunogenicity data, the percentage of paiiicipants with positive ADA and NAb 
each will be smnmai·ized. Listings and summaiy tabulations of the ADA and NAb data at 
baseline and post-randomization will be generated. For paiticipants with positive ADA or 
NAb, the magnitude (titer), time of onset, and duration of ADA or NAb response will also be 
described, if data pennit. The potential impact of i1nmunogenicity on PK and clinical 
response including pha1macodynainic markers, safety/tolerability and efficacy will be 
explored, if waiTanted by the data. 
9.4.5. Tertiary/Exploratory Endpoint(s) 
 
9.4.6. Other Safety Analyses 
All safety analyses will be perfo1med on the safety population. 
Smnmai·ies and analyses of safety pai·ameters will include all paiiicipants in the safety 
analysis set. 
AEs, ECGs, BP, hea1t rate, and safety laborato1y data will be reviewed on an ongoing basis 
during the study to evaluate the safety of paiiicipants. Any clinical laborato1y, ECG, BP, and 

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PR abnormalities of potential clinical concern will be described. Safety data will be presented 
in tabular and/or graphical format and summarized descriptively, where appropriate. 
Medical history and physical examination, as applicable, collected during the course of the 
study will be considered source data and will not be required to be reported, unless otherwise 
noted. However, any untoward findings identified on physical examination conducted during 
the active collection period will be captured as AEs, if those findings meet the definition of 
an AE. Demographic data collected at screening will be reported. 
9.4.6.1. Electrocardiogram Analyses 
Changes from baseline for the ECG parameters QT interval, heart rate, QTcF interval, PR 
interval, and QRS complex will be summarized by treatment and time. 
The number (%) of participants with maximum postdose QTc values and maximum increases 
from baseline in the following categories will be tabulated by treatment: 
 
Safety QTc Assessment 
 
Degree of Prolongation 
Mild (msec) 
Moderate (msec) 
Severe (msec) 
Absolute value 
>450-480 
>480-500 
>500 
Increase from baseline 
30-60 
>60 
In addition, the number of participants with uncorrected QT values >500 msec will be 
summarized. 
If more than 1 ECG is collected at a nominal time after dose administration (for example, 
triplicate ECGs), the mean of the replicate measurements will be used to represent a single 
observation at that time point. If any of the 3 individual ECG tracings has a QTcF value 
>500 msec, but the mean of the triplicates is not >500 msec, the data from the participant’s 
individual tracing will be described in a safety section of the CSR in order to place the 
>500-msec value in appropriate clinical context. However, values from individual tracings 
within triplicate measurements that are >500 msec will not be included in the categorical 
analysis unless the average from the triplicate measurements is also >500 msec. Changes 
from baseline will be defined as the change between the postdose QTcF value and the 
average of the time-matched baseline triplicate values on Day -1, or the average of the 
predose triplicate values on Day 1. 
In addition, an attempt will be made to explore and characterize the relationship between 
plasma concentration and QT interval length using a PK/PD modeling approach. If a PK/PD 
relationship is found, the impact of participant factors (covariates) on the relationship will be 
examined. 
The analysis of ECG results will be based on participants in the safety analysis set with 
baseline and on-treatment ECG data. Baseline is defined as a Cycle 1 Day 1 pre-dose. 
ECG measurements (an average of the triplicate measurements) will be used for the 
statistical analysis and all data presentations. Any data obtained from ECGs repeated for 

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safety reasons after the nominal time-points will not be averaged along with the preceding 
triplicates. Interval measurements from repeated ECGs will be included in the outlier 
analysis (categorical analysis) as individual values obtained at unscheduled time points. 
QT intervals will be corrected for HR (QTcF) using standard correction factors 
(ie, Fridericia’s (default correction), Bazett’s, and possibly a study-specific factor, as 
appropriate). Data will be summarized and listed for QT, HR, RR, PR, QRS, QTcF (and 
other correction factors, eg, QTcB as appropriate), and dose. Individual QT (all evaluated 
corrections) intervals will be listed by time and dose. The most appropriate correction factor 
will be selected and used for the following analyses of central tendency and outliers and used 
for the study conclusions. Descriptive statistics (n, mean, median, standard deviation, 
minimum, and maximum) will be used to summarize the absolute corrected QT interval and 
changes from baseline in corrected QT after treatment by dose and time point. Details of 
additional analysis (if any) will be specified in SAP. 
9.4.6.2. Adverse Events 
AEs will graded by the investigator according to the CTCAE version 5.0 and coded using 
MedDRA, except CRS, which will be graded by ASTCT criteria (Lee et al, 2019). AE data 
will be reported in tables and listings. Summaries of AEs by mapped terms, appropriate 
thesaurus level, toxicity grade, and seriousness and relationship to study treatment will be 
presented, as well as summaries of AEs leading to death and premature withdrawal from 
study treatment. The number and percentage of participants who experienced any AE, SAE, 
treatment related AE, and treatment related SAE will be summarized according to worst 
toxicity grades. The summaries will present AEs both on the entire study period and by cycle 
(Cycle 1 and Cycles beyond 1). Listings of DLTs and deaths will be provided. 
9.4.6.3. Laboratory Test Abnormalities 
The number and percentage of participants who experienced laboratory test abnormalities 
will be summarized according to worst toxicity grade observed for each laboratory assay. 
The analyses will summarize laboratory tests both on the entire study period and by cycle 
(Cycle 1 and Cycles beyond 1). For laboratory tests without CTCAE grade definitions, 
results will be categorized as normal, abnormal, or not done. 
9.4.7. Other Analyses 
Pharmacogenomic or biomarker data from Banked Biospecimens may be collected during or 
after the trial and retained for future analyses; the results of such analyses are not planned to 
be included in the CSR. 
9.4.7.1. Analysis of Biomarker Endpoints 
For blood and biopsy samples, summary statistics (eg, the mean and standard deviation, 
median, and minimum/maximum levels of continuous, and frequencies and percentages of 
categorical biomarker measures) will be determined at baseline and post-treatment (if 
available). Further analysis will be specified in the SAP. 

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Clinically relevant and interpretable biomarker assessments generated for Primary and 
Secondary objectives will be summarized in the CSR. Results from exploratory endpoint 
analyses will be reported in the CSR or will be disclosed to the scientific community through 
publication(s) at scientific conferences and/or in peer-reviewed scientific journals. Given the 
exploratory nature of exploratory objectives and endpoints, the associated data analyses may 
not be complete at the time of CSR authoring. 
9.4.7.2. Population Pharmacokinetic Analysis or PK/PD Modeling 
PF-07209960 PK and pharmacodynamic data from this study may be analyzed using 
population modeling approaches and may also be pooled with data from other future studies 
to investigate any association between PF-07209960 exposure and biomarkers or selected 
safety and/or efficacy endpoints. The results of these analyses, if performed, may be reported 
separately from the clinical study report. 
9.5. Interim Analyses 
No formal interim analysis will be conducted for this study. As this is an open-label study, 
the sponsor may conduct unblinded reviews of the data during the course of the study for the 
purpose of safety assessment, facilitating dose-escalation decisions, facilitating PK modeling, 
and/or supporting clinical development. 
9.6. Data Monitoring Committee or Other Independent Oversight Committee 
This study will not use a DMC. However, a DLRM will convene for dose escalation 
decisions. The actual dose selected at each dose decision may be at or below the model’s 
recommended dose as determined by the members of the DLRM after considering all safety 
information. The review team will composed of investigator(s), Pfizer GCL, Pfizer Study 
Clinician, and Pfizer study manager. Additional members may be added as needed (eg, 
Clinical Pharmacologist Lead, Translational Oncology, Safety Risk Lead or designee and 
Pfizer Biostatistics representative). A quorum, defined as >50% of the participating 
investigators or their qualified designee (ie, subinvestigator or research nurse or study 
coordinator possessing hard copy documentation [eg, email] of the investigator’s vote 
regarding the dose level review), must be in attendance for the DLRM. The DLRM will be 
rescheduled if a quorum is not reached. 
Voting members of the DLRM will include the Pfizer medical monitor, the Pfizer Safety 
Risk Lead or designee, and all participant investigators or their qualified medical doctor 
designee(s). The team may recommend escalation to the next planned dose, escalation to an 
intermediate dose (a dose lower than the next planned dose), continuation or delay in dosing, 
repetition or expansion or a cohort, de-escalation at a lower dose, or termination of the study. 
All available study day including demographics, medical history (including tumor history), 
concomitant medications, AEs, ECGs, vital signs, laboratory results, and emerging PK or PD 
data will be reviewed. Data to be reviewed may be unqueried. 

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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations 
10.1.1. Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with the following: 
• Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines; 
• Applicable ICH GCP guidelines; 
• Applicable laws and regulations, including applicable privacy laws. 
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor and submitted to an 
IRB/EC by the investigator and reviewed and approved by the IRB/EC before the study is 
initiated. 
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants. 
The investigator will be responsible for the following: 
• Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC. 
• Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures. 
• Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/EC, European regulation 536/2014 
for clinical studies (if applicable), and all other applicable local regulations. 
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP 
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately. 
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of ICH GCP that the investigator becomes aware 
of. 

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10.1.2. Financial Disclosure 
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study. 
10.1.3. Informed Consent Process 
The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions regarding the 
study. The participant or his/her legally authorized representative should be given sufficient 
time and opportunity to ask questions and to decide whether or not to participate in the trial. 
Participants must be informed that their participation is voluntary. Participants or their 
legally authorized representative will be required to sign a statement of informed consent that 
meets the requirements of 21 CFR 50, local regulations, ICH guidelines, HIPAA 
requirements, where applicable, and the IRB/EC or study center. 
The investigator must ensure that each study participant or his or her legally authorized 
representative is fully informed about the nature and objectives of the study, the sharing of 
data related to the study, and possible risks associated with participation, including the risks 
associated with the processing of the participant’s personal data. 
The participant must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant. 
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities. 
The investigator further must ensure that each study participant or his or her legally 
authorized representative is fully informed about his or her right to access and correct his or 
her personal data and to withdraw consent for the processing of his or her personal data. 
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was obtained. 
The authorized person obtaining the informed consent must also sign the ICD. 
Participants must be reconsented to the most current version of the ICD(s) during their 
participation in the study. 
A copy of the ICD(s) must be provided to the participant or the participant’s legally 
authorized representative. 

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A participant who is rescreened is not required to sign another ICD if the rescreening occurs 
within 28 days from the previous ICD signature date. 
Unless prohibited by local requirements or IRB/EC decision, the ICD will contain a separate 
section that addresses the use of samples for optional additional research. The optional 
additional research does not require the collection of any further samples. The investigator or 
authorized designee will explain to each participant the objectives of the additional research. 
Participants will be told that they are free to refuse to participate and may withdraw their 
consent at any time and for any reason during the storage period. A separate signature will be 
required to document a participant's agreement to allow specimens to be used for additional 
research. Participants who decline to participate in this optional additional research will not 
provide this separate signature. 
10.1.4. Data Protection 
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data. 
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible for 
determining whether a personal data breach has in fact occurred and, if so, providing breach 
notifications as required by law. 
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to his or her actual identity and medical record identification. In 
case of data transfer, the sponsor will protect the confidentiality of participants’ personal data 
consistent with the clinical study agreement and applicable privacy laws. 
10.1.5. 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, and/or 
www.pfizer.com, and other public registries 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. 

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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. 
EudraCT 
Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies in 
accordance with the format and timelines set forth by EU requirements. 
www.pfizer.com 
Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used 
to identify individual participants have been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are 
posted to www.clinicaltrials.gov. 
Documents within marketing authorization packages/submissions 
Pfizer complies with the European Union Policy 0070, the proactive publication of clinical 
data to the EMA website. Clinical data, under Phase 1 of this policy, includes clinical 
overviews, clinical summaries, CSRs, and appendices containing the protocol and protocol 
amendments, sample CRFs, and statistical methods. Clinical data, under Phase 2 of this 
policy, includes the publishing of individual participant data. Policy 0070 applies to new 
marketing authorization applications submitted via the centralized procedure since 
01 January 2015 and applications for line extensions and for new indications submitted via 
the centralized procedure since 01 July 2015. 
Data Sharing 
Pfizer provides researchers secure access to patient-level data or full CSRs for the purposes 
of “bona-fide scientific research” that contributes to the scientific understanding of the 
disease, target, or compound class. Pfizer will make available data from these trials 
24 months after study completion. Patient-level data will be anonymized in accordance with 
applicable privacy laws and regulations. CSRs will have personally identifiable information 
redacted. 
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. 
10.1.6. Data Quality Assurance 
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 

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responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF. 
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. 
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password protected or secured in a locked room to 
prevent access by unauthorized third parties. 
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents. This 
verification may also occur after study completion. It is important that the investigator(s) and 
their relevant personnel are available during the monitoring visits and possible audits or 
inspections and that sufficient time is devoted to the process. 
Monitoring details describing strategy (eg, risk-based initiatives in operations and quality 
such as risk management and mitigation strategies and analytical risk-based monitoring), 
methods, responsibilities, and requirements, including handling of noncompliance issues and 
monitoring techniques (central, remote, or on-site monitoring), are provided in the Study 
Management Plan. 
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data. 
Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements. 
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained. 
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems. 
The investigator(s) will notify the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study. Furthermore, the investigator will cooperate 
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the sponsor or its agent, whenever feasible, to be present during the inspection. The 
investigator site and investigator will promptly resolve any discrepancies that are identified 

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between the study data and the participant's medical records. The investigator will promptly 
provide copies of the inspection findings to the sponsor or its agent. Before response 
submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings. 
10.1.7. Source Documents 
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator site. 
Data reported on the CRF or entered in the eCRF that are from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available. 
Definition of what constitutes source data can be found in the Study Management Plan. 
Description of the use of computerized system is documented in the CRF Guidelines. 
10.1.8. Study and Site Start and Closure 
The study start date is the date on which the clinical study will be open for recruitment of 
participants. 
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date. 
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time upon notification to the sponsor 
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants. 
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to: 
• Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor's procedures, or GCP guidelines; 
• Inadequate recruitment of participants by the investigator; 
• Discontinuation of further study intervention development. 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 

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requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up. 
Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights. 
10.1.9. Publication Policy 
The results of this study may be published or presented at scientific meetings by the 
investigator after publication of the overall study results or 1 year after the end of the study 
(or study termination), whichever comes first. 
The investigator agrees to refer to the primary publication in any subsequent publications 
such as secondary manuscripts, and submits all manuscripts or abstracts to the sponsor 30 
days before submission. This allows the sponsor to protect proprietary information and to 
provide comments and the investigator will, on request, remove any previously undisclosed 
confidential information before disclosure, except for any study- or Pfizer 
intervention-related information necessary for the appropriate scientific presentation or 
understanding of the study results. 
For all publications relating to the study, the investigator will comply with recognized ethical 
standards concerning publications and authorship, including those established by the 
International Committee of Medical Journal Editors. 
The sponsor will comply with the requirements for publication of the overall study results 
covering all investigator sites. In accordance with standard editorial and ethical practice, the 
sponsor will support publication of multicenter studies only in their entirety and not as 
individual site data. In this case, a coordinating investigator will be designated by mutual 
agreement. 
Authorship of publications for the overall study results will be determined by mutual 
agreement and in line with International Committee of Medical Journal Editors authorship 
requirements. 
If publication is addressed in the clinical study agreement, the publication policy set out in 
this section will not apply. 
10.1.10. Sponsor’s Qualified Medical Personnel 
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the supporting study 
documentation/study portal or other electronic system. 
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, participants are provided with a contact card at the time of informed 
consent. The contact card contains, at a minimum, protocol and study intervention identifiers, 
participant numbers, contact information for the investigator site, and contact details for a 
contact center in the event that the investigator site staff cannot be reached to provide advice 

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on a medical question or problem originating from another healthcare professional not 
involved in the participant’s participation in the study. The contact number can also be used 
by investigator staff if they are seeking advice on medical questions or problems; however, it 
should be used only in the event that the established communication pathways between the 
investigator site and the study team are not available. It is therefore intended to augment, but 
not replace, the established communication pathways between the investigator site and the 
study team for advice on medical questions or problems that may arise during the study. The 
contact number is not intended for use by the participant directly, and if a participant calls 
that number, he or she will be directed back to the investigator site. 

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10.2. Appendix 2: Clinical Laboratory Tests 
The following safety laborato1y tests will be perfo1med at times defined in the SoA section of 
this protocol. Additional laborato1y results may be reported on these samples as a result of 
the method of analysis or the type of analyzer used by the clinical laborato1y, or as derived 
from calculated values. These additional tests would not require additional collection of 
blood. Unscheduled clinical laborato1y measurements may be obtained at any time during the 
study to assess any perceived safety issues. 
 
Table 6. 
Safety Laboratory Tests 
 
Hematology 
Chemistry 
Coagulation 
Urinalysis 
Pregnancy 
Test 
Other Labs 
Hemoglobin 
Platelets 
WBC 
Differential 
• Absolute 
Neutrophils 
• Absolute 
Lymphocytes 
• Absolute 
Eosinophils 
• Absolute 
Basophils 
ALT 
AST 
Bicarbonate 
CRP 
Fen-itin 
Alic Phos 
Sodium 
Potassium 
Magnesium 
Chloride 
Total Calcium 
Total bilirubinb 
Total Protein 
BUN 
Creatinine 
U1-ic Acid 
Glucose 
(nonfasted) 
LDH 
Albumin 
Phosphorus or 
Phosphate 
PT/INR 
PTT/aPTT 
TT 
Fibrinogen 
D-dimer 
pH 
Glucose (qual) 
Protein (qual) 
Blood (qual) 
Ketones 
Nitrates 
Leukocyte 
esterase 
Urobilogen 
Bilimbin 
Microscopy" 
WOCBP 
(semm 
/m-ine) 
Serology: 
HBsAg, 
Anti-HCV 
antibody! 
• HCVRNA 
(only if 
Anti-HCV is 
positive) 
n 
a. 
Only if urine dipstick is positive for blood, protein, nitrites, or leukocyte esterase. 
b. 
For potential Hy's Law cases, in addition to repeating AST and ALT, laborato1y tests should include albumin, 
creatine kinase, total bilirubin, direct and indirect bilimbin, ganuna-glutamyl transferase, PT/INR, alkaline 
phosphatase, total bile acids and acetaminophen dmg and/or protein adduct levels. 
c. 
 Cytok.ines for central labevaluation will be collected if CRS is suspected. Local labevaluation of cytokine is only 
required if the site requires this info,mation for participant management. 
d. 
Polymerase chain reaction for HCV RNA if anti-HCV antibody is positive. 
 
Investigators must document their review of each laborato1y safety report. 

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10.3. Appendix 3: Adverse Events: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting 
10.3.1. Definition of AE 
 
AE Definition 
• 
 An AE is any untoward medical occunence in a patient or clinical study 
paiiicipant, temporally associated with the use of study intervention, whether or 
not considered related to the study intervention. 
• 
NOTE: An AE can therefore be any unfavorable and unintended sign (including 
an abnonnal laborato1y finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention. 
 
 
Events Meeting the AE Definition 
• 
 Any abno1mal laborato1y test results (hematology, clinical chemistiy, or urinalysis) 
or other safety assessments (eg, ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator. Any abno1mal laborato1y test 
results that meet any of the conditions below must be recorded as an AE: 
• 
Is associated with accompanying symptoms; 
• 
Requires additional diagnostic testing or medical/surgical intervention; 
• 
 Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional 
concomitant drng tl'eatment, or other therapy. 
• 
 Exacerbation of a chronic or intennittent preexisting condition including either an 
increase in frequency and/or intensity of the condition. 
• 
New conditions detected or diagnosed after study intervention administl'ation even 
though it may have been present before the staii of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected diug-drng interaction. 
• 
 Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be repo1ied as an 
AE/SAE unless it is an intentional overdose taken with possible 
suicidal/self-haiming intent. Such overdoses should be repo1ied regai·dless of 
sequelae. 

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• 
 The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will be 
repo1ied as an AE or SAE if they fulfill the definition of an AE or SAE and meet the 
requirements as per Section 8.3.8.1. Also, "lack of efficacy" or "failure of expected 
phannacological action" does not constitute an AE or SAE. 
 
 
Events NOT Meeting the AE Definition 
• 
 Any clinically significant abnonnal laborato1y findings or other abnonnal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the paiiicipant's condition. 
• 
 The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
paiiicipant's condition. 
• 
 Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
• 
 Situations in which an untowai·d medical occunence did not occur (social and/or 
convenience admission to a hospital). 
• 
 Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present 
or detected at the sta1i of the study that do not worsen. 
• 
 Worsening of signs and symptoms of the malignancy under study should be recorded 
as AEs in the appropriate section of the CRF. Disease progression assessed by 
measurement of malignant lesions on radiographs or other methods should not be 
repo1ied as AEs. 
10.3.2. Definition of SAE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study). 
 
An SAE is defined as any untoward medical occurrence that, at any dose: 
g. Results in death 
h. Is life-threatening 
The te1m "life-threatening" in the definition of "serious" refers to an event in which the 
paiiicipant was at risk of death at the time of the event. It does not refer to an event that 
hypothetically might have caused death if it were more severe. 

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i. Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious. 
Hospitalization for elective treatment of a preexisting condition that did not worsen from 
baseline is not considered an AE. 
j. 
Results in persistent disability/incapacity 
• The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
• This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption. 
k. Is a congenital anomaly/birth defect 
l. Other situations: 
• Medical or scientific judgment should be exercised in deciding whether SAE 
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 events 
should usually 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. 
• 
Progression of the malignancy under study (including signs and symptoms of 
progression) should not be reported as an SAE 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 or within the active collection period, then the 
event leading to death must be recorded as an AE on the CRF, and as an SAE 
with CTCAE Grade 5 (see the Assessment of Intensity section). 

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• 
 Suspected trnnsmission via a Pfizer product of an infectious agent, pathogenic or 
non-pathogenic, is considered serious. The event may be suspected from clinical 
symptoms or laborato1y findings indicating an infection in a patient exposed to a 
Pfizer product. The tenns "suspected transmission" and "transmission" are 
considered synonymous. These cases are considered unexpected and handled as 
serious expedited cases by phannacovigilance personnel. Such cases are also 
considered for repo1iing as product defects, if appropriate. 
 
10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs 
 
AE and SAE Recording/Reporting 
The table below summarizes the requirements for recording adverse events on the CRF 
and for repo1iing serious adverse events on the CT SAE Repo1i Fonn to Pfizer Safety. 
These requirements are delineated for 3 types of events: (1) SAEs; (2) nonserious 
adverse events (AEs); and (3) exposure to the study intervention under study during 
pregnancy or breastfeeding, and occupational exposure. 
It should be noted that the CT SAE Repo1i Fo1m for repo1iing of SAE infonnation is not 
the same as the AE page of the CRF. When the same data are collected, the fonns must 
be completed in a consistent manner. AEs should be recorded using concise medical 
tenninology and the same AE te1m should be used on both the CRF and the CT SAE 
Repo1i Fo1m for repo1iing of SAE infonnation. 
Safety Event 
Recorded on the CRF 
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness 
SAE 
All 
All 
Nonserious AE 
All 
None 
Exposure to the study 
intervention under study 
All AEs/SAEs associated 
with exposure during 
All (and EDP supplemental 
fonn for EDP) 
during pregnancy or 
pregnancy or breastfeeding 
breastfeeding, and 
occupational exposure 
Occupational exposure is 
Note: fuclude all SAEs 
associated with exposure 
during pregnancy or 
not recorded. 
breastfeeding. fuclude all 
AEs/SAEs associated with 
occupational exposure. 

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•  When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laborato1y repo1is, and diagnostic 
repo1is) related to the event. 
• The investigator will then record all relevant AE/SAE infonnation in the CRF. 
• It is not acceptable for the investigator to send photocopies of the paiiicipant's 
medical records to Pfizer Safety in lieu of completion of the CT SAE Repo1i 
Fonn/ AE/SAE CRF page. 
• There may be instances when copies of medical records for ce1iain cases are 
requested by Pfizer Safety. In this case, all paiiicipant identifiers, with the exception 
of the paiiicipant number, will be redacted on the copies of the medical records 
before submission to Pfizer Safety. 
•  The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical infonnation. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE/SAE. 
Assessment of Intensity 
The investigator will make an assessment of intensity for each AE and SAE repo1ied 
during the study and assign it to 1 of the following NCI CTCAE grading categories: 
GRADE Clinical Description of Severity 
1 
MILD adverse event 
2 
MODERATE adverse event 
3 
SEVERE adverse event 
4 
LIFE-THREATENING consequences; urgent intervention indicated 
5 
DEATH RELATED TO adverse event 
Note: CRS will be assessed according to the modified grading described by ASTCT as 
described in Appendix 9. 
An event is defined as "serious" when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe. 

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Assessment of Causality 
• 
The investigator is obligated to assess the relationship between study inte1vention 
and each occmTence of each AE/SAE. 
• 
A "reasonable possibility" of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be mled out. 
• 
The investigator will use clinical judgment to detennine the relationship. 
• 
Alternative causes, such as underlying disease(s), conc01nitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study inte1vention 
administration, will be considered and investigated. 
• 
The investigator will also consult the IB and/or product infonnation, for marketed 
products, in his/her assessment. 
• 
For each AE/SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE/SAE and has provided an assessment of causality. 
• 
There may be situations in which an SAE has occmTed and the investigator has 
minimal infonnation to include in the initial repo1i to the sponsor. However, it is 
very important that the investigator always make an assessment of causality for 
every event before the initial transmission of the SAE data to the sponsor. 
• 
The investigator may change his/her opinion of causality in light of follow-up 
infonnation and send an SAE follow-up repo1i with the updated causality 
assessment. 
• 
The causality assessment is one of the criteria used when determining regulato1y 
reporting requirements. 
• 
 If the investigator does not know whether or not the study inte1vention caused the 
event, then the event will be handled as "related to study inte1vention" for repo1iing 
purposes, as defined by the sponsor. In addition, if the investigator detennines that 
an SAE is associated with study procedures, the investigator must record this causal 
relationship in the source documents and CRF, and repo1i such an assessment in the 
dedicated section of the CT SAE Repo1i Fo1m and in accordance with the SAE 
repo1iing requirements. 

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Follow-up of AEs and SAEs 
• 
 The investigator is obligated to perfonn or anange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the AE or SAE as fully as 
possible. This may include additional laborato1y tests or investigations, 
histopathological examinations, or consultation with other healthcare providers. 
• 
New or updated info1mation will be recorded in the originally completed CRF. 
• 
The investigator will submit any updated SAE data to the sponsor within 24 hours of 
receipt of the infonnation. 
 
10.3.4. Reporting of SAEs 
 
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool 
• 
The primaiy mechanism for repo1ting an SAE to Pfizer Safety will be the electronic 
data collection tool. 
• 
 If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to repo1t the event within 24 hours. 
• 
The site will enter the SAE data into the electronic system as soon as the data 
become available. 
• 
After the study is completed at a given site, the electronic data collection tool will be 
taken off-line to prevent the entiy of new data or changes to existing data. 
• 
 If a site receives a report of a new SAE from a study paiticipant or receives updated 
data on a previously reported SAE after the electi·onic data collection tool has been 
taken off-line, then the site can repo1t this info1mation on a paper SAE fo1m (see 
next section) or to Pfizer Safety by telephone. 
 
 
SAE Reporting to Pfizer Safety via CT SAE Report Form 
• 
Facsimile ti·ansmission of the CT SAE Repo1t Fo1m is the prefened method to 
ti·ansmit this info1mation to Pfizer Safety. 
• 
 In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the CT SAE Repo1t Fonn sent by overnight mail or courier 
service. 

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• Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Report Form pages within the designated reporting 
time frames. 

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10.4. Appendix 4: Contraceptive Guidance 
10.4.1. Male Participant Reproductive Inclusion Criteria 
Male participants are eligible to participate if they agree to the following requirements during 
the intervention period and for at least 4 months after the last dose of study intervention, 
which corresponds to the time needed to eliminate reproductive safety risk of the study 
intervention(s): 
• Refrain from donating sperm. 
PLUS either: 
• Be abstinent from heterosexual intercourse with a female of childbearing potential as 
their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and 
agree to remain abstinent. 
OR 
• Must agree to use a male condom when engaging in any activity that allows for 
passage of ejaculate to another person. 
10.4.2. Female Participant Reproductive Inclusion Criteria 
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at 
least 1 of the following conditions applies: 
• Is not a WOCBP (see definitions below in Appendix 4, Section 10.4.3). 
OR 
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure 
rate of <1% per year), preferably with low user dependency, as described below 
during the intervention period and for at least 4 months after the last dose of study 
intervention, 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. 
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 
10.4.3. Woman of Childbearing Potential 
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below). 

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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. 
Women in the following categories are not considered WOCBP: 
1. Premenopausal female with 1 of the following: 
• Documented hysterectomy; 
• Documented bilateral salpingectomy; 
• Documented bilateral oophorectomy. 
For individuals with permanent infertility due to an alternate 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. Postmenopausal female. 
• A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause. In addition, a 
• High FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years old and not using hormonal 
contraception or HRT. 
• Female on HRT and whose menopausal status is in doubt will be required to 
use one of the nonestrogen hormonal highly effective contraception methods 
if they wish to continue their HRT during the study. Otherwise, they must 
discontinue HRT to allow confirmation of postmenopausal status before study 
enrollment. 
10.4.4. Contraception Methods 
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials. 
Highly Effective Methods That Have Low User Dependency 
1. 
Implantable progestogen-only hormone contraception associated with 
inhibiton of ovulation 
2. 
Intrauterine device (IUD) 

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3. 
Intrauterine hormone-releasing system (IUS) 
4. 
Bilateral tubal occlusion 
5. 
Vasectomized partner 
• Vasectomized partner is a highly effective contraceptive method provided 
that the partner is the sole sexual partner of the WOCBP and the absence 
of spem 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 
1. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation. 
• Oral; 
• Intravaginal; 
• Transdermal; 
• Injectable. 
2. Progestogen-only hormone contraception associated with inhibition of ovulation. 
• Oral; 
• Injectable. 
3. Sexual abstinence. 
• 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. 
One of the following effective barrier methods must be used in addition to the highly 
effective methods listed above that are user dependent: 
• Male or female condom with or without spermicide; 
• Cervical cap, diaphragm, or sponge with spermicide; 

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• A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods). 

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10.5. Appendix 5: Genetics 
Use/Analysis of DNA 
• Genetic variation may impact a participant’s response to study intervention, 
susceptibility to, and severity and progression of disease. Therefore, where local 
regulations and IRBs/ECs allow, a blood sample will be collected for DNA analysis. 
• The scope of the genetic research may be narrow (eg, 1 or more candidate genes) or 
broad (eg, the entire genome), as appropriate to the scientific question under 
investigation. 
• The samples may be analyzed as part of a multistudy assessment of genetic factors 
involved in the response to PF-07209960 or study interventions of this class to 
understand treatments for the disease(s) under study or the disease(s) themselves. 
• The results of genetic analyses may be reported in the CSR or in a separate study 
summary, or may be used for internal decision making without being included in a 
study report. 
• The sponsor will store the DNA samples in a secure storage space with adequate 
measures to protect confidentiality. 
• The samples will be retained as indicated: 
• Samples for banking will be stored indefinitely or for another period as per local 
requirements. 
• Participants may withdraw their consent for the storage and/or use of their Banked 
Biospecimens at any time by making a request to the investigator; in this case, any 
remaining material will be destroyed. Data already generated from the samples will 
be retained to protect the integrity of existing analyses. 
• Banked Biospecimens will be labeled with a code. The key between the code and the 
participant’s personally identifying information (eg, name, address) will be held at the 
study site and will not be provided to the sample bank. 

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10.6. Appendix 6: Liver Safety: Suggested Actions 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 an “adaptor” or are “susceptible.” 
LFTs are not required as a routine safety monitoring procedure in this study. However, 
should an investigator deem it necessary to assess LFTs because a participant presents with 
clinical signs/symptoms, such LFT results should be managed and followed as described 
below. 
In the majority of DILI cases, elevations in AST and/or ALT precede TBili elevations (>2 × 
ULN) by several days or weeks. The increase in TBili typically occurs while AST/ALT is/are 
still elevated above 3 × ULN (ie, AST/ALT and TBili values will be elevated within the same 
laboratory sample). In rare instances, by the time TBili 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 TBili 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 TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili 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 TBili 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: 
• Preexisting 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). 

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• Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches 
>3 × ULN (whichever is smaller). 
Rises in AST/ALT and TBili 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. 
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 TBili for suspected cases of 
Hy’s law, 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 anticoagulated 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 coformulated 
product in prescription or over-the-counter medications), recreational drug, 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 and 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 
TBili 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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10.7. Appendix 7: ECG Findings of Potential Clinical Concern 
 
ECG Findings That May Qualify as AEs 
• 
Marked sinus bradycardia (rate <40 bpm) lasting minutes. 
• 
New PR interval prolongation >280 msec. 
• 
New prolongation of QTcF to >480 msec (absolute) or by60 msec from 
baseline. 
• 
New-onset atrial flutter or fibrillation, with controlled ventricular response rate: 
ie, rate <120 bpm. 
• 
New-onset type I second-degree (Wenckebach) AV block of>30 seconds' 
duration. 
• 
Frequent PVCs, triplets, or sho1i intervals (<30 seconds) of consecutive 
ventricular complexes. 
ECG Findings That May Qualify as SAEs 
• 
QTcF prolongation >500 msec. 
• 
New ST-T changes suggestive of myocardial ischemia. 
• 
New-onset left bundle branch block (QRS >120 msec). 
• 
New-onset right bundle branch block (QRS >120 msec). 
• 
Symptomatic bradycardia. 
• 
Asystole: 
• 
 In awake, symptom-free paiiicipants in sinus rhythm, with documented 
periods of asystole3.0 seconds or any escape rate <40 bpm, or with an 
escape rhythm that is below the AV node. 
• 
In awake, symptom-free paiiicipants with atrial fibrillation and bradycai·dia 
with 1 or more pauses of at least 5 seconds or longer. 
• 
Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate 
>120 bpm. 
• 
 Sustained supraventriculai·tachycai·dia (rate>120 bpm) ("sustained"= sho1i 
duration with relevant symptoms or lasting >1 minute). 

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• Ventricular rhythms >30 seconds' duration, including idioventi·icular rhythm 
(heart rate <40 bpm), accelerated idioventi·icular rhythm (HR >40 bpm to <100 
bpm), and monomorphic/polymorphic venti·icular tachycardia (HR >100 bpm 
(such as torsades de pointes)). 
• Type II second-degree (Mobitz II) AV block. 
• Complete (third-degree) herui block. 
ECG Findings That Qualify as SAEs 
• Change in pattern suggestive of new myocru·dial infru·ction. 
• Sustained venti·iculru·tachyruThythmias (>30 seconds' duration). 
• Second- or third-degree AV block requiring pacemaker placement. 
• Asystolic pauses requiring pacemaker placement. 
•  Ati·ial flutter or fibrillation with rapid venti·iculru·response requiring 
cardioversion. 
• Venti·icular fibrillation/flutter. 
•  At the discretion of the investigator, any ruThythmia classified as an adverse 
expenence. 
The enlllllerated list of major events of potential clinical concem are recollllllended as "ale1ts" or 
notifications from the core ECG laborato1y to the investigator and Pfizer study team, and not to be 
considered as all-inclusive of what to be repo1ted as AEs/SAEs. 

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10.8. Appendix 8: Detailed Dose Escalation/De-escalation Scheme for BLRM Design 
An adaptive Bayesian design using EWOC will guide the dose escalation for PF-07209960. 
The use of Bayesian response adaptive designs for Phase 1 studies has been advocated for 
and is one of the key elements of the FDA’s Critical Path Initiative (Rogatko et al, 2007; 
Neuenschwander et al, 2015). 
The BLRM will be set-up for the dose-toxicity relationship of PF-07209960 when 
administered as a single agent. This Bayesian analysis will be based on DLT data (absence or 
presence of DLT) during the first cycle (DLT observation period) accumulated throughout 
the dose escalation. This appendix provides details of the statistical models. The derivation of 
prior distributions, general description of MAP approach (in the event that alternative IV 
dosing is used), performance check of the model, some hypothetical dose escalation 
scenarios, and operating characteristics are presented in a technical supplement to this 
appendix. 
10.8.1. Statistical Models 
10.8.1.1. Prior Specifications for monotherapy BLRM 
In the dose escalation Part 1, the DLT relationship will be described by a 2-parameter BLRM 
formulated as follows: 
logit(π(d)) = log(a) + β log ( d 
 
d 
Where, π(d) is the probability that a participant has a DLT during the first cycle (28 days) 
when PF-07209960 is given as single agent. The parameter d* is the reference dose in the 
model and is used to scale the doses of PF-07209960. The α, β 0 are the parameters of the 
model such that a (>0) is the PF-07209960 odds of a DLT at d∗; and f3 (>0) is the increase in 
the log-odds of a DLT by a unit increase in log-dose. 
The Bayesian approach requires the specification of prior distributions for the model 
parameters log(a) and log(f3). Available preclinical toxicology makes it difficult to predict 
toxicity profile of PF-07209960 single agent in humans. For this reason, the priors of the 
model parameter distribution are defined using a weakly informative prior. This approach 
allows for considerable uncertainty, so that the a-priori range for the parameters covers a 
wide range of plausible values. 
Meta-Analytic-Predictive Priors Approach 
A MAP prior may be used to define the prior for any or all of the treatment arms in the dose 
escalation in order to account for heterogeneity between the available DLT data and the 
actual study protocol population and treatment regimen/schedule. For example, if alternative 
IV dosing is used a MAP prior may be used to incorporate SC dosing data. Furthermore, a 
) 
∗ 

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MAP prior maybe used instead of, or in addition to a weakly informative prior to form a 
weighted mixture prior and account for uncertainty. A mixture prior can take the form 
 
p × BVNMAP + (1 − p) × BVNWeak 
The weights of the mixture prior are driven by clinical judgement. The aim of the MAP prior 
approach for treatment i is to derive a prior distribution for the logistic parameters 
(log(a∗), log(f3∗)) using prior DLT data, available from previously conducted trial, or from 
i 
i 
the same study but with another regimen. 
 
Let ri and nibe the number of participants with a DLT, and the total number of participants at 
dose di in the DLT data available from the historical trial. The corresponding probability of a 
DLT is rrdi. The model specifications are as follows: 
ri|rrdi ~Bin(rrdi, ni) 
 
 ogit(rrdi) 
di 
= log(ai) + f3ilog(d∗) 
(log(ai) , log(f3i))|µ, 1/~BVN(µi, 1/i) 
(log(a∗) , log(f3∗))|µ, 1/~BVN(µi, 1/i) 
i 
i 
The parameter µi = (µil, µi2) is the mean for the logistic parameter, and 1/i is the between- 
regimen/study covariance matrix. Covariance matric 1/i is defined by the standard devations 
of (til, ti2), and correlation ri. 
The following priors will be used for these parameters: 
• normal priors for µil and µi2; 
• log-normal priors for til and ti2; 
• a uniform prior for ri. 
To further specify the details of these distributions the principles described in 
(Neuenschwander et al, 2015) will be followed. The MAP prior for model parameters of 
PF-07209960, is the predictive distribution. 
(log(a∗) , log(f3∗))|(ri, ni) 
i 
i 
Since the predictive distribution is not available analytically, the MCMC method is used to 
simulate values from this distribution. This is implemented using JAGS version 4.10. 
 
Sensitivity Analysis 
Despite being prespecified in the protocol, some AEs that fall into the category of DLTs may 
need to be considered differently. Conversely, some AEs that are not defined as a DLT per 
protocol should be considered by the dose escalation BLRM. Accordingly, the new concept 

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of an “equivocal” DLT or AE is introduced: most AE/DLTs are considered “unequivocal,” 
but certain types of AEs/DLTs are considered to be “equivocal.” To mitigate the risk of 
dichotomizing and misclassifying DLTs, the sensitivity analysis that uses those weighted 
equivocal DLT/AE data into the BLRM model estimation will also be performed. The 
BLRM model uses all the equivocal and unequivocal AE/DLT data, but the variability 
associated with equivocal AEs/DLTs (less interpretable) is increased. So, the model 
recommendations are more heavily weighted towards unequivocal data. See below for the 
posterior distribution of the BLRM model parameters based on the theory of power prior. 
 
Suppose n participants treated at dose d with m unequivocal DLTs and r equivocal 
DLTs/AEs, and the weight w for the equivocal data, then based on the power prior, 
Posterior(a, f3|d, m, r, w) ∝ L(m|a, f3, d, w) × L(r|a, f3, d, w) × prior(a, f3) 
∝ p(a, f3, d)m × [1 − p(a, f3, d)]n-r-mp(a, f3, d)rw × prior(a, f3), 
Where L is the likelihood of the observed DLT data, and p(a, f3, d) is the probability of DLT 
at dose d that is modeled by logistic regression in BLRM. To achieve the equality sign, 
approximate normalizing constant is required. The contribution of equivocal AEs/DLTs to 
the data (likelihood) and the Bayesian posterior estimation of the MTD are weighted; the 
weight parameter controls the influence and can be interpreted as a precision parameter for 
equivocal AE/DLT data, similar to the scale parameter in the power prior for the Bayesian 
historical borrowing. The weight for an equivocal DLT is decreased (eg, 1 decreased to 0.5) 
and the weight for an equivocal AE (non-DLT by protocol) is increased (eg, 0 increased to 
0.5). To maintain the integrity of a trial, the weights pre-specified as 0.5 in the analysis. If all 
the investigators and the sponsor agree on the equivocal DLT/AE data, the DLT weighting 
approach could be the primary dose escalation method. This DLT weighting approach 
provides a flexible and powerful tool that may incorporate the clinician’s valuable experience 
with some specific DLTs/AEs and improve MTD estimation in dose-escalation trials. 

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10.9. Appendix 9: CRS Mitigation and Management 
CRS is a non-antigen-specific cytokine-associated toxicity that occurs as a result of 
high-level immune activation. CRS is a potentially life-threatening toxicity that has been 
observed following administration of immune-base therapies for cancer (antibodies and 
adoptive T cell therapies). CRS is likely to be a common toxicity that can be managed 
through supportive care and anti-cytokine interventions. 
In cases of suspected CRS, a serum sample should be provided for cytokine release assay 
analysis by the local lab (see Section 8.2.5 ) so as long as the sampling does not interfere 
with the medical treatment of the participant. 
Early intervention should be undertaken at the first sign of CRS; signs may include pyrexia, 
tachycardia, tachypnea and/or hypotension and are temporally related to PF-07209960 in the 
absence of alternative etiologies. 
The ASTCT CRS criteria proposed by Lee et al. (Lee et al, 2019) as presented in Table 7 will 
be used for the assessment of the CRS severity grade which will be captured on the AE CRF 
and on the CRS CRF. 
 
Table 7. 
ASTCT CRS Revised Grading System 
 
CRS parameter: 
Fever* 
With Hypotension 
And/or† Hypoxia 
Grade 1 
Temp. ≥38°C 
None 
None 
Grade 2 
Temp. ≥38°C 
Not requiring vasopressors 
Requiring low-flow‡ nasal 
cannula, low-flow‡ facemask or 
blow-by 
Grade 3 
Temp. ≥38°C 
Requiring a vasopressor with or 
without vasopressin 
Requiring high-flow‡ nasal 
cannula, high-flow‡ facemask, 
nonrebreather mask, or Venturi 
mask 
Grade 4 
Temp. ≥38°C 
Requiring multiple vasopressors 
(excluding vasopressin) 
Requiring positive pressure (eg, 
CPAP, BiPAP, intubation and 
mechanical ventilation) 
Organ toxicities associated with CRS should still be graded according to CTCAE v5.0 and do not influence 
CRS grading. 
* Fever is defined as temperature ≥38°C and not attributable to any other cause. In participants who have 
CRS then receive antipyretic or anticytokine therapy such as tocilizumab or steroids, fever is no longer 
required to grade subsequent CRS severity. In this case, CRS grading is driven by hypotension and/or 
hypoxia. 
† CRS grade is determined by the more severe event: hypotension or hypoxia not attributable to any other 
cause. For example, a patient with temperature of 39.5°C hypotension requiring 1 vasopressor, and hypoxia 
requiring low-flow nasal cannula is classified as Grade 3 CRS. 
‡ Low-flow nasal cannula or facemask is defined as oxygen delivered at ≤6 L/min. Low flow also includes 
blow-by oxygen delivery, sometimes used in pediatrics. High-flow nasal cannula or facemask is defined as 
oxygen delivered at >6 L/min. This is modified from original ASTCT criteria to differentiate between low- 
flow and high-flow facemask. 

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The definitions for high-dose vasopressors are shown in Table 8. 
 
Table 8. 
Definition of High Dose Vasopressor 
 
Pressor 
High Dose 
(doses less than these would be considered low) 
Norepinephrine monotherapy 
20 g/min 
Dopamine monotherapy 
10 g/kg/min 
Phenylephrine monotherapy 
200 g/min 
Epinephrine monotherapy 
10 g/min 
If on vasopressin 
Vasopressin + norepinephrine 
equivalent of 10 g/min* 
If on combination vasopressors 
(not vasopressin) 
Norepinephrine equivalent of 
20 g/min* 
* VASST Trial vasopressor equivalent equation: norepinephrine equivalent dose = [norepinephrine (g/min)] 
+ [dopamine (g/kg/min) ÷ 2] + [epinephrine (g/min)] + [phenylephrine (g/min) ÷10 
 
CRS Management Guidelines (Neelapu et al, 2018; Neelapu, 2019): 
These may be modified as needed by the responsible Investigator according to the best 
practices at their institute. 
ASTCT Grade 1 CRS: 
• Monitor vital signs for worsening of condition. 
Fever 
• Acetaminophen/paracetamol and hypothermia blanket for the treatment of fever. 
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen can be used as 
second treatment option for fever if not contraindicated. 
• Assess for infection using blood and urine cultures, and chest radiography. 
• Empiric broad-spectrum antibiotics and filgrastim if neutropenic. 
• Maintenance IV fluids for hydration. 
• Symptomatic management of constitutional symptoms or organ toxicity. 
• Consider tocilizumab 8 mg/kg* IV or siltuximab 11 mg/kg IV for persistent (lasting 
>3 days) and refractory fever. 
ASTCT Grade 2 CRS: 
• Monitor vital signs every 4 hours for worsening of condition. 
Fever 
• Manage as in Grade 1 CRS. 

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Hypotension 
• IV fluid bolus of 500-1000 ml of normal saline. Can give second IV fluid bolus if 
systolic blood pressure remains <90 mmHg. 
• Consider tocilizumab 8 mg/kg (maximum dose 800 mg) IV or siltuximab 11 mg/kg 
IV for treatment of hypotension refractory to fluid boluses; tocilizumab can be 
repeated after 6 h if needed. 
• If hypotension persists after 2 fluid boluses and anti-IL-6 therapy, start vasopressors, 
consider transfer to ICU, obtain ECHO, and initiate other methods of hemodynamic 
monitoring. 
• In participants at high-risk (bulky disease, older age or comorbidities) or if 
hypotension persists after 1-2 doses of anti-IL-6 therapy, dexamethasone can be used 
at 10 mg IV every 6 hrs. 
Hypoxia 
• Supplemental oxygen. 
• Tocilizumab or siltuximab ± corticosteroids and supportive care, as indicated for 
hypotension. 
ASTCT Grade 3 CRS: 
• Monitor patient (including continuous ECG monitoring) in an ICU and obtain ECHO if 
not done already. 
Fever 
• Manage as in Grade 1 CRS. 
Hypotension 
• IV boluses, as needed, as recommended for Grade 2 CRS. 
• Tocilizumab and siltuximab as recommended for Grade 2 CRS if not administered 
previously. 
• Vasopressors as needed. 
• Dexamethasone 10 mg IV every 6 hrs; if refractory, increase to 20 mg IV every 6 hrs. 
Hypoxia 
• Supplemental oxygen including high-flow oxygen delivery. 
• Tocilizumab or siltuximab plus corticosteroids and supportive care, as described 
above. 
ASTCT Grade 4 CRS: 
• Monitor patient (including continuous ECG monitoring) in an ICU and obtain ECHO if 
not done already. 

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Fever 
• Manage as in Grade 1 CRS. 
Hypotension 
• IV boluses, anti-IL-6 therapy, vasopressors, and hemodynamic monitoring as 
recommended for grade 3 CRS. 
• Methylprednisolone 1 g/day IV. 
Hypoxia 
• Supplemental oxygen via positive pressure/mechanical ventilation. 
• Tocilizumab or siltuximab plus corticosteroids and supportive care, as described 
above. 

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10.10. Appendix 10: Alternative Measures During Public Emergencies 
The alternative study measures described in this section are to be followed during public 
emergencies, including the COVID-19 pandemic. This appendix applies for the duration of 
the COVID-19 pandemic and will become effective for other public emergencies only upon 
written notification from Pfizer. 
Use of these alternative study measures are expected to cease upon the return of business as 
usual circumstances (including the lifting of any quarantines and travel bans/advisories). 
10.10.1. Eligibility 
While SARS-CoV2 testing is not mandated for this study, local clinical practice standards for 
testing should be followed. A patient should be excluded if he/she has a positive test result 
for SARS-CoV2 infection, is known to have asymptomatic infection, or is suspected of 
having active SARS-CoV2. Patients with active infections are excluded from study 
participation. 
10.10.2. Telehealth Visits 
In the event that in-clinic study visits cannot be conducted, every effort should be made to 
follow-up on the safety of study participants at scheduled visits per the Schedule of 
Activities or unscheduled visits. Telehealth visits may be used to continue to assess 
participant safety and collect data points. Telehealth includes the exchange of healthcare 
information and services via telecommunication technologies (eg, audio, video, video- 
conferencing software) remotely, allowing the participant and the investigator to 
communicate on aspects of clinical care, including medical advice, reminders, education, and 
safety monitoring. The following assessments must be performed during a telehealth visit: 
• Review and record any AEs and SAEs since the last contact. Refer to Section 8.3. 
• Review and record any new concomitant medications or changes in concomitant 
medications since the last contact. 
• Review and record contraceptive method and results of pregnancy testing. Confirm that 
the participant is adhering to the contraception method(s) required in the protocol. Refer 
to Appendix 4 and Appendix 10, Section 10.10.3.1 of this appendix regarding pregnancy 
tests. 
Study participants must be reminded to promptly notify site staff about any change in their 
health status. 
10.10.3. Alternative Facilities for Safety Assessments 
An alternative facility to perform laboratory tests, imaging, or ECGs may be appropriate for 
study procedures that are standard safety assessments and are routinely performed by the 
alternative facility. 

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10.10.3.1. Laboratory Testing 
If a study participant is unable to visit the site for protocol-specified safety laboratory 
evaluations, testing may be conducted at a local laboratory if permitted by local 
regulations. The local laboratory may be a standalone institution or within a hospital. The 
following safety laboratory evaluations may be performed at a local laboratory: 
• Hematology 
• Chemistry 
• Coagulation: PT/INR, PTT/aPTT; TT, fibrinogen; D-dimer for Cycle 1 
• Thyroid Test: TSH, free T4 
CC 
 
• Pregnancy test 
• Urinalysis 
If a local laboratory is used, qualified study site personnel must order, receive, and review 
results. Site staff must collect the local laboratory reference ranges and certifications/ 
accreditations for filing at the site. Laboratory test results are to be provided to the site staff 
as soon as possible. The local laboratory reports should be filed in the participant’s source 
documents/medical records. Relevant data from the local laboratory report should 
be recorded on the CRF. 
If a participant requiring pregnancy testing cannot visit a local laboratory for pregnancy 
testing, a home urine pregnancy testing kit with a sensitivity of at least 25 mIU/mL may be 
used by the participant to perform the test at home, if compliant with local regulatory 
requirements. The pregnancy test outcome should be documented in the participant’s source 
documents/medical records and relevant data recorded on the CRF. Confirm that the 
participant is adhering to the contraception method(s) required in the protocol. 
10.10.3.2. Electrocardiograms 
If the participant is unable to visit the study site for ECGs, the participant may visit an 
alternative facility to have the ECGs performed. Qualified study site personnel must order, 
receive, and review results. 
10.10.3.3. Echocardiogram or MUGA 
If the participant is unable to visit the study site for echocardiogram or MUGA, the 
participant may visit an alternative facility to have the echocardiogram or MUGA performed. 
Qualified study site personnel must order, receive, and review results. 
CCI 

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10.10.4. Study Intervention 
If the safety of a trial participant is at risk because they cannot complete required evaluations 
or adhere to critical mitigation steps, then discontinuing that participant from study 
intervention must be considered. 
The following is recommended for the administration of PF-07209960 for participants who 
have active confirmed (positive by regulatory authority-approved test) or presumed (test 
pending/clinical suspicion) SARS-CoV2 infection: 
• For symptomatic participants with active SARS-CoV2 infection, PF-07209960 
should be delayed for at least 14 days from the start of symptoms. This delay is 
intended to allow the resolution of symptoms of SARS-CoV2 infection. 
• Prior to restarting treatment, the participant should be afebrile for 72 hours, and 
SARS-CoV2-related symptoms should have recovered to ≤Grade 1 for a minimum of 
72 hours. Notify the study team when treatment is restarted. 
• Continue to consider potential drug-drug interactions as described in Section 6.5 for 
any concomitant medication administered for treatment of SARS-CoV2 infection. 
10.10.5. Adverse Events and Serious Adverse Events 
If a participant has COVID-19 during the study, this should be reported as an adverse event 
(AE) or serious adverse events (SAE) and appropriate medical intervention provided. 
Temporary discontinuation of the study intervention may be medically appropriate until the 
participant has recovered from COVID-19. 
It is recommended that the investigator discuss temporary or permanent discontinuation of 
study intervention with the study medical monitor. 

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10.11. Appendix 11: Response Evaluation Criteria in Solid Tumors (RECIST) version 
1.1 Guidelines 
Adapted from E.A. Eisenhauer, et al: New response evaluation criteria in solid tumours: 
Revised RECIST guideline version 1.1 (Eisenhauer et al, 2009). 
CATEGORIZING LESIONS AT BASELINE 
Measurable Lesions 
• Lesions that can be accurately measured in at least one dimension. 
• Lesions with longest diameter twice the slice thickness and at least 10 mm or greater 
when assessed by CT or MRI (slice thickness 5-8 mm). 
• Lesions with longest diameter at least 20 mm when assessed by Chest X-ray. 
• Superficial lesions with longest diameter 10 mm or greater when assessed by caliper. 
• Malignant lymph nodes with the short axis 15 mm or greater when assessed by CT. 
NOTE: The shortest axis is used as the diameter for malignant lymph nodes, longest axis for 
all other measurable lesions. 
Non-Measurable Disease 
Non-measurable disease includes lesions too small to be considered measurable (including 
nodes with short axis between 10 and 14.9 mm) and truly non-measurable disease such as 
pleural or pericardial effusions, ascites, inflammatory breast disease, leptomeningeal disease, 
lymphangitic involvement of skin or lung, clinical lesions that cannot be accurately measured 
with calipers, abdominal masses identified by physical exam that are not measurable by 
reproducible imaging techniques. 
• Bone disease: Bone disease is non-measurable with the exception of soft tissue 
components that can be evaluated by CT or MRI and meet the definition of measurability 
at baseline. 
•  Previous local treatment: A previously irradiated lesion (or lesion subjected to other 
local treatment) is non-measurable unless it has progressed since completion of treatment. 
Normal Sites 
• Cystic lesions: Simple cysts should not be considered as malignant lesions and should 
not be recorded either as target or non-target disease. Cystic lesions thought to represent 

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cystic metastases can be measurable lesions, if they meet the specific definition above. If 
non-cystic lesions are also present, these are preferred as target lesions. 
• Normal nodes: Nodes with short axis <10 mm are considered normal and should not be 
recorded or followed either as measurable or non-measurable disease. 
Recording Tumor Assessments 
All sites of disease must be assessed at baseline. Baseline assessments should be done as 
close as possible prior to study start. For an adequate baseline assessment, all required scans 
must be done within 28 days prior to randomization and all disease must be documented 
appropriately. If baseline assessment is inadequate, subsequent statuses generally should be 
non-evaluable. 
Target Lesions 
All measurable lesions up to a maximum of 2 lesions per organ, 5 lesions in total, 
representative of all involved organs, should be identified as target lesions at baseline. Target 
lesions should be selected on the basis of size (longest lesions) and suitability for accurate 
repeated measurements. Record the longest diameter for each lesion, except in the case of 
pathological lymph nodes for which the short axis should be recorded. The sum of the 
diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target lesions at 
baseline will be the basis for comparison to assessments performed on study. 
• If two target lesions coalesce the measurement of the coalesced mass is used. If a large 
target lesion splits, the sum of the parts is used. 
• Measurements for target lesions that become small should continue to be recorded. If a 
target lesion becomes too small to measure, 0 mm should be recorded if the lesion is 
considered to have disappeared; otherwise a default value of 5 mm should be recorded. 
NOTE: When nodal lesions decrease to <10 mm (normal), the actual measurement should 
still be recorded. 
Non-Target Disease 
All non-measurable disease is non-target. All measurable lesions not identified as target 
lesions are also included as non-target disease. Measurements are not required but rather 
assessments will be expressed as CR, Non-CR/Non-PD, PD, Non-evaluable (NE). Multiple 
non-target lesions in one organ may be recorded as a single item on the case report form (eg, 
‘multiple enlarged pelvic lymph nodes’ or ‘multiple liver metastases’). 
OBJECTIVE RESPONSE STATUS AT EACH EVALUATION 
Disease sites must be assessed using the same technique as baseline, including consistent 
administration of contrast and timing of scanning. If a change needs to be made the case must 

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be discussed with the radiologist to determine if substitution is possible. If not, subsequent 
objective statuses might be non-evaluable. 
Target Disease 
1. Complete Response (CR): Complete disappearance of all target lesions with the 
exception of nodal disease. All target nodes must decrease to normal size (short axis <10 
mm). All target lesions must be assessed. 
2. Partial Response (PR): Greater than or equal to 30% decrease under baseline of the sum 
of diameters of all target measurable lesions. The short diameter is used in the sum for 
target nodes, while the longest diameter is used in the sum for all other target lesions. All 
target lesions must be assessed. 
3. Stable: Does not qualify for CR, PR or Progression. All target lesions must be assessed. 
Stable can follow PR only in the rare case that the sum increases by less than 20% from 
the nadir, but enough that a previously documented 30% decrease no longer holds. 
4. Objective Progression (PD): 20% increase in the sum of diameters of target measurable 
lesions above the smallest sum observed (over baseline if no decrease in the sum is 
observed during therapy), with a minimum absolute increase of 5 mm. 
5. Non-evaluable (NE): Progression has not been documented, and 
• One or more target measurable lesions have not been assessed; or 
• One or more target lesions cannot be measured accurately (eg, poorly visible unless 
due to being too small to measure); or 
• One or more target lesions were excised or irradiated. 
Non-Target Disease 
1. CR: Disappearance of all non-target lesions and normalization of tumor marker levels. 
All lymph nodes must be ‘normal’ in size (<10 mm short axis). 
2. Non-CR/Non-PD: Persistence of any non-target lesions and/or tumor marker level above 
the normal limits. 
3. PD: Unequivocal progression of pre-existing lesions. Generally, the overall tumor 
burden must increase sufficiently to merit discontinuation of therapy. In the presence of 
SD or PR in target disease, progression due to unequivocal increase in non-target disease 
should be rare. 
4. NE: Progression has not been determined and one or more non-target sites were not 
assessed or assessment methods were inconsistent with those used at baseline. 

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New Lesions 
The appearance of any new unequivocal malignant lesion indicates PD. If a new lesion is 
equivocal, for example due to its small size, continued assessment will clarify the etiology. If 
repeat assessments confirm the lesion, then progression should be recorded on the date of the 
initial assessment. A lesion identified in an area not previously scanned will be considered a 
new lesion. 
Supplemental Investigations 
• If CR determination depends on a residual lesion that decreased in size but did not 
disappear completely, it is recommended the residual lesion be investigated with biopsy 
or fine needle aspirate. If no disease is identified, objective status is CR. 
• If progression determination depends on a lesion with an increase possibly due to 
necrosis, the lesion may be investigated with biopsy or fine needle aspirate to clarify 
status. 
Subjective Progression 
Participants requiring discontinuation of treatment without objective evidence of disease 
progression should not be reported as PD on tumor assessment CRFs. This should be 
indicated on the end of treatment CRF as off treatment due to Global Deterioration of Health 
Status. Every effort should be made to document objective progression even after 
discontinuation of treatment. 
 

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If the protocol allows enrollment of patients with only non-target disease, the following table 
will be used: 
 
Best Overall Response 
The best overall response (BOR) is the best response recorded from the randomization until 
disease progression or death due to any cause. This is derived from the sequence of objective 
statuses. Objective statuses are not considered after objective progression is documented or 
after start of the first anticancer treatment post discontinuation of protocol treatment. BOR 
for each patient will be derived as one of the following categories: 
• Complete response (CR): At least one objective status of CR documented before 
progression. 
• Partial response (PR): At least one objective status of PR documented before 
progression. 
• Stable disease (SD): At least one objective status of stable documented at least 8 weeks 
after randomization date and before progression but not qualifying as CR, PR. 
• Progressive Disease (PD): Objective status of progression within 16 weeks of 
randomization, not qualifying as CR, PR or SD. 
• Non-evaluable (NE): Progression not documented within 16 weeks after randomization 
and no other response category applies. 

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10.12. Appendix 12: Subcutaneous Injection Site Locations 
 
Injection site locations include a maximum of 8 unique administration sites distributed across 
4 abdominal quadrants with a possibility of up to 2 injection locations per quadrant. Location 
1 is proximal to the umbilicus and Location 2 is distal to the umbilicus. 
Administer the required number of injections in the following order: 
1. Lower Left Quadrant Location 1; 
2. Lower Right Quadrant Location 1; 
3. Lower Left Quadrant Location 2; 
4. Lower Right Quadrant Location 2; 
5. Upper Right Quadrant Location 1; 
6. Upper Left Quadrant Location 1; 
7. Upper Right Quadrant Location 2; 
8. Upper Left Quadrant Location 2. 
Injections to the abdomen are preferred. If SC injections in the abdominal location are not 
possible, SC injections can be administered in a distributed manner in the thighs. SC 
injections in the upper extremities (eg, deltoid, upper and lower arm) are not permitted. 
Track the patient’s injection site(s) sequentially on this diagram with a red pen and mark the 
injection sites on the patient’s abdomen according to your clinic’s standard practice. 

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Record the location, time of each injection and any ISRs in the patient’s source records and 
study CRF. Complete one CRF per injection. 

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10.13. Appendix 13: ECOG Performance Status* 
 

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10.14. Appendix 14: Management for Immune-Related Adverse Events 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a 
Gastrointestinal irAEs 
Severity of Diarrhea/Colitis 
(NCI-CTCAE v5.0) 
Initial Management 
Follow-up Management 
K;rade 1 
IDian-hea: <4 stools/day over baseline 
Colitis: asymptomatic 
Continue study treatment 
Symptomatic treatment (eg 
[operarnide) 
• 
Close monitoring for worsening 
symptoms. 
Educate participant to report 
orsening illllllediately. 
If worsens: Treat as Grade 2, 3 or 
- 
K;rade 2 
IDian-hea: 4 to 6 stools per day over 
!Baseline; IV fluids indicated <24 hours;
Mt interfering with ADL 
Colitis: abdominal pain; blood in stool 
Withhold study treatment 
Symptomatic treatment 
If improves to Gradel: Resume 
study treatment. 
If persists >5-7 days or recurs: 
rTreat as Grade 3 or 4. 
K;rade 3 to 4 
PiaIThea (Grade 3):?:.7 stools per day 
pver Baseline; incontinence; IV fluids 
24 hours; interfering with ADL 
Colitis (Grade 3): severe abdominal 
in, medical intervention indicated, 
peritoneal signs 
K}rade 4: life-threatening, perforation 
Withhold for Grade 3 
Permanently discontinue study 
eatment for Grade 4 or recuITent 
Kirade 3 
1.0 to 2.0 mg/kg/day prednisone 
Irv or equivalent 
Add prophylactic antibiotics for 
ppportunistic infections 
Consider lower endoscopy 
If improves: Continue steroids until 
Kn-adel, then taper over at least 
1 month; resume study treatment 
!following steroids taper (for initial 
Kn-ade 3). 
If worsens, persists >3 to 5 days, or 
1t·ecurs after improvement. 
Add infliximab 5 mg/kg (if no 
ontraindication). 
-Note: infliximab should not be 
ed in cases of perforation or 
sepsis. 

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Dermatoloidcal irAEs 
Grade of Rash 
(NCI-CTCAE vS.O) 
Initial Management 
Follow-up Management 
rade 1 to2 
Covering90% body swface area 
Continue study treatment 
Symptomatic therapy (for 
example, antihistamines, topical 
steroids) 
n
a
If persists > I to 2 weeks or recurs: 
Withhold study treatment 
Consider skin biopsy 
Consider 0.5-1.0 mg/kg/day 
llrednisone or equivalent. Once 
!improving, taper steroids over at least I
onth, consider prophylactic antibiotics
Ifor oppo1tunistic infections, and reswne 
!study treatment following steroids 
per. 
Ifworsens: Treat as Grade 3 to 4. 
K;rade 3 to 4 
K}rade 3: Covering >30% body 
isurface area; 
K}rade 4: Life threatening 
K:onsequences 
Withhold study treatment for 
Grade 3 
Pe1manently discontinue for a
Grade 4 or recwTent Grade 3 
Consider skin biopsy 
Dennatology consult 
1.0 to 2.0 mg/kg/day prednisone 
or equivalent 
Add prophylactic antibiotics for 
oppo1tunistic infections 
If improves to GradeI: Taper 
!steroids over at least I month; reswne 
istudy treatment following steroids 
per (for initial Grade 3). 

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r 
 
 
 
 
 
 
r 
Pulmonary irAEs 
Grade of Pneumonitis 
(NCI-CTCAE v5.0) 
Initial Management 
Follow-up M.anagement 
ade 1 
!Radiographic changes only 
Consider withholding study 
treatment 
Monitor for symptoms every 2 to 
3 days 
Consider Pulmonary and 
Infectious Disease consults 
Re-assess at least every 3 weeks. 
If worsens: Treat as Grade 2 or 
Grade 3 to 4. 
ade2 
Mild to moderate new symptoms 
Withhold study treatment 
Pulmonary and Infectious Disease 
consults 
Monitor symptoms daily; 
consider hospitalization 
1.0 to 2.0 mg/kg/day prednisone 
or equivalent 
Add prophylactic antibiotics for 
opportunistic infections 
Consider bronchoscopy, lung 
biopsy 
Re-assess every 1 to 3 days If 
'mproves: 
When symptoms return to Grade 
::;I, taper steroids over at least 
1 month, and then resume study 
reatment following steroids taper. 
If not improving after 2 weeks or 
worsening: Treat as Grade 3 to 4. 
rade 3 to 4 
Kirade 3: Severe new symptoms; 
New/worsening hypoxia; 
Kirade 4: Life-threatening 
Pe1manently discontinue study 
treatment. 
Hospitalize 
Pulmonary and Infectious Disease 
consults 
1.0 to 2.0 mg/kg/day prednisone 
or equivalent 
Add prophylactic antibiotics for 
opportunistic infections 
Consider bronchoscopy, lung 
biopsy 
If improves to Grade ::;l: Taper 
steroids over at least 1 month. 
If not improving after 48 hours or 
worsening: Add additional 
'mmunosuppression (for example, 
infliximab, cyclophosphamide, IV 
mmunoglobulin, or mycophenolate 
mofetil). 

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r 
Hepatic irAEs 
Grade of Liver Test Elevation 
(NCI-CTCAE v5.0) 
Initial Management 
Follow-up Management 
ade 1 
KJrade I AST or ALT >ULN to 
.Ox ULN and/or Total bilimbin 
ULN to 1.5 x ULN 
Continue study treatment 
Continue liver function monitoring 
If worsens: Treat as Grade 2 or 3 - 4. 
K;rade 2 
ST or ALT >3.0 to5 xU L N  
nd/or total bilimbin >1.5 to 3 x 
IULN 
Withhold study treatment 
Increase frequency of monitoring 
o eve1y 3 days 
o
If returns to GradeI: Resume routine 
monitoring; resume study treatment. 
If elevation persists >5 to 7 days or 
rsens: Treat as Grade 3 to 4. 
rade 3 to 4 
ST or ALT >5 x ULN and/or total 
IJilimbin >3 x ULN 
Pennanently discontinue study 
reatment 
Increase frequency of monitoring 
o eve1y 1 to 2 days 
1.0 to 2.0 mg/kg/day prednisone 
or equivalent 
Add prophylactic antibiotics for 
opportunistic infections 
Consult gastroenterologist/ 
hepatologist 
Consider obtaining MRI/CT scan 
of liver and liver biopsy if 
clinically wa1rnnted 
If returns to GradeI: Taper steroids 
K>ver at least I month. 
If does not improve in >3 to 5 days, 
worsens or rebounds: Add 
niycophenolate mofetil I gram (g) tv.•ice 
klaily. 
If no response within an additional 3 to 
IS days, consider other 
immunosuppressants per local 
iguidelines. 

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Renal irAEs 
Grade of Creatinine Increased 
(NCI-CTCAE vS.0) 
Initial Management 
Follow-up 
Manae:ement 
K;rade 1 
K=:reatinine increased >ULN to 1.5 x 
IULN 
Continue study treatment 
Continue renal function 
nonitoring. 
If worsens: Treat as Grade 2 
o 3 or 4. 
rade 2 to3 
t:reatinine increased >I.5 and ::;6 x 
IULN 
Withhold study treatment 
Increase frequency of monitoring to 
eve1y 3 days 
1.0 to 2.0 mg/kg/day prednisone or 
equivalent. 
Add prophylactic antibiotics for 
opportunistic infections 
Consider renal biopsy 
If retums to Grade ::;I: Taper 
steroids over at least 1 month, 
and resume study treatment 
following steroids taper. 
If worsens: Treat as Grade 4. 
K;rade 4 
K=:reatinine increased >6 x ULN 
Pe1manently discontinue study 
treatment 
Monitor creatinine daily 
1.0 to 2.0 mg/kg/day prednisone or 
equivalent. 
Add prophylactic antibiotics for 
opportunistic infections 
Consider renal biopsy 
Nephrology consult 
If retums to Grade ::Sl: Taper 
steroids over at least 1 month. 

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Cardiac irAEs 
Myocarditis 
Initial Management 
Follow-up 
Mana ement 
ew onset of cardiac signs or 
m toms and / or new laboratory 
ac 
Withhold study treatment 
If symptoms improve and 
Hospitalize 
none-mediated etiology 
• s mled out, re-start study 
In the presence of life threatening cardiac 
of 
ecompensation, consider transfer to a 
If symptoms do not 
nyocarditis 
acility experienced in advanced heart failure 
nd an-hythmia management 
• mprove/worsen, viral 
yocarditis is excluded, 
Consult cardiologist to establish etiology and d irnmune-mediated 
ule-out immune-mediated myocarditis 
tiology is suspected or 
Guideline based suppo1tive treatment as per onfinned following 
ardiology consult* 
ardiology consult, manage 
illllllune-mediated 
Consider myocardial biopsy if recommende 
yocarditis. 
er cardiology consult 
none-mediated myocarditis 
Pemianently discontinue study treatment 
Once improving,  taper 
Guideline based suppo1tive treatment as 
teroids over at least 1 
ppropriate as per cardiology consult.* 1.0 to 
onth. 
.0 mg/kg/day prednisone or equivalent 
If no improvement or 
Add prophylactic antibiotics for 
rorsening, consider 
ppo1tunistic infections 
dditional 
unosuppressants (eg, 
athioprine, cyclosporine 
). 
*Local guidelines, or eg, ESC or AHA guidelines 
ESC guidelines website: https://wwv.r.escardio.org/Guidelines/Clinical-Practice-Guidelines AHA guidelines 
website: 
http://professional.heait.org/professional/GuidelinesStatements/searchresults.jsp?q=&y=&t=1001 

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Endocrine irAEs 
Endocrine Disorder 
Initial Management 
Follow-up Management 
Grade 1 or Grade 2 
endocrinopathies 
(hypothyroidism, 
hyperthyroidism, adrenal 
insufficiency, type I diabetes 
mellitus) 
-Continue study treatment 
-Endocrinology consult if needed 
-Start thyroid hormone replacement therapy 
(for hypothyroidism), 
anti-thyroid treatment (for hyperthyroidism), 
corticosteroids (for adrenal insufficiency) or 
insulin (for Type I diabetes mellitus) as 
appropriate 
-Rule-out secondary endocrinopathies (ie, 
hypopituitarism / hypophysitis) 
-Continue hormone 
replacement/suppression and 
monitoring of endocrine 
function as appropriate. 
Grade 3 or Grade 4 
endocrinopathies 
(hypothyroidism, 
hyperthyroidism, adrenal 
insufficiency, type I diabetes 
mellitus) 
-Withhold study treatment 
-Consider hospitalization 
- Endocrinology consult 
-Start thyroid hormone replacement therapy 
(for hypothyroidism), 
anti-thyroid treatment (for hyperthyroidism), 
corticosteroids (for adrenal insufficiency) or 
insulin (for type I diabetes mellitus) as 
appropriate 
-Rule-out secondary endocrinopathies (ie, 
hypopituitarism / hypophysitis) 
-Resume study treatment once 
symptoms and/or laboratory 
tests improve to Grade ≤1 
(with or without hormone 
replacement/suppression). 
-Continue hormone 
replacement/suppression and 
monitoring of endocrine 
function as appropriate. 
Hypopituitarism/ Hypophysitis 
(secondaryendocrinopathies) 
-If secondary thyroid and/or adrenal 
insufficiency is confirmed (ie, subnormal 
serum FT4 with inappropriately low TSH 
and/or low serum cortisol with inappropriately 
low ACTH): 
-Refer to endocrinologist for dynamic testing 
as indicated and measurement of other 
hormones (FSH, LH, GH/IGF-1, PRL, 
testosterone in men, estrogens in women) 
-Hormone replacement/suppressive therapy as 
appropriate 
-Perform pituitary MRI and visual field 
examination as indicated 
-If hypophysitis is confirmed: 
-Continue study treatment if mild symptoms 
with normal MRI. Repeat the MRI in 1 month 
-Withhold study treatment if moderate, severe 
or life-threatening symptoms of hypophysitis 
and/or abnormal MRI. Consider 
hospitalization. Initiate corticosteroids (1 to 2 
-Resume study treatment once 
symptoms and hormone tests 
improve to Grade ≤1 (with or 
without hormone 
replacement). 
-In addition, for hypophysitis 
with abnormal MRI, resume 
study treatment only once 
shrinkage of the pituitary 
gland on MRI/CT scan is 
documented. 
-Continue hormone 
replacement/suppression 
therapy as appropriate. 

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Endocrine irAEs 
!Endocrine Disorder 
llnitial Management 
IFollow-up Management 
ng/kg/day prednisone or equivalent) followed 
by corticosteroids taper during at least 1 montb
Add prophylactic antibiotics for opportunistic 
!infections 
 
 
Other irAEs (not described above) 
Grade of other irAEs 
<NCI-CTCAE v5.0) 
Initial Management 
Follow-up Management 
Grade 2 or Grade 3 clinical 
signs or symptoms 
suggestive of a potential 
irAE 
-Withhold study treatment pending 
clinical investigation 
-If irAE is ruled out, manage as 
appropriate according to the 
diagnosis and consider re- 
staiting study treatment 
-If irAE is confinned, treat as 
Grade 2 or 3 irAE. 
Grade 2 irAE or first 
occurrence of Grade 3 irAE 
-Withhold study treatment 
-1.0 to 2.0 mg/kg/day prednisone 
or equivalent 
-Add prophylactic antibiotics 
for oppo1tunistic infections 
-Specialty consult as aooropriate 
-If improves to Grade ::Sl: 
-Taper steroids over at least 
1 month and resume study 
treatment following steroids 
taper. 
Recurrence of same Grade 3 
irAEs 
-Pe1manently discontinue study 
treatment 
-1.0 to 2.0 mg/kg/day prednisone or 
equivalent 
-Add prophylactic antibiotics for 
oppo1tunistic infections 
-Specialty consult as aooropriate 
-If improves to Grade ::;1 : 
Taper steroids over at least 
1 month. 
Grade4 
-Pe1manently discontinue study 
treatment 
-1.0 to 2.0 mg/kg/day prednisone or 
equivalent and/or other 
illllllunosuppressant as needed 
-Add prophylactic antibiotics for 
oppo1tunistic infections 
-Specialty consult 
-If improves to Grade ::;1 : 
Taper steroids over at least 
1 month. 
Requirement for 10 mg per 
day or greater prednisone 
or equivalent for more than 
12 weeks for reasons other 
than ho1·monal replacement 
for adrenal insufficiency 
Persistent Grade 2 or 3 irAE 
lasting 12 weeks or longer 
-Pe1manently discontinue study 
treatment 
-Specialty consult 

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10.15. Appendix 15: Management of Infusion Related Reactions 
 
NCI CTCAE Severity G1·ade 
Treatment Modification 
Grade 1 - mild 
Mild transient reaction; infusion intenuption not 
indicated; intervention not indicated. 
Decrease the infusion rate by 50% and monitor closely 
for any worsening. 
Grade 2 - moderate 
Therapy or infusion intenuption indicated but 
responds promptly to symptomatic treatment (for 
example, antihistamines, NSAIDs, narcotics, IV 
fluids; prophylactic medications indicated for 
24 hours. 
Temporarily discontinue infusion. 
Resume infusion at 50% of previous rate once infusion- 
related reaction has resolved or decreased to at least 
Grade 1 in severity, and monitor closely for any 
worsening. 
Grade 3 or Grade 4 - severe01·life-threatening 
Grade 3: Prolonged (for example, not rapidly 
responsive to symptomatic medication and/or brief 
intenuption of infusion); recwTence of symptoms 
following initial improvement; hospitalization 
indicated for clinical sequelae. 
Grade 4: Life-threatening consequences; urgent 
intervention indicated. 
Stop the infusion immediately and disconnect infusion 
tubing from the patient. 
Treatment should be pennanently discontinued. 
If infusion rate has been decreased by 50% due to an infusion reaction, it must remain decreased for the next 
scheduled infusion. If no infusion reaction is observed at the next scheduled infusion, the infusion rate may be 
retwned to baseline at subsequent infusions. 

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10.16. Appendix 16: Abbreviations 
The following is a list of abbreviations that may be used in the protocol. 
 
Abbreviation 
Term 
ACTH 
adrenocorticotropic hormone 
ADA 
Anti-drug antibodies 
ADL 
activities of daily living 
AE 
adverse event 
AESI 
adverse events of special interest 
AIDS 
acquired immunodeficiency syndrome 
ALK 
anaplastic lymphoma kinase 
ALT 
alanine aminotransferase 
am 
anti-mouse 
ANC 
absolute neutrophil count 
aPTT 
activated partial prothrombin time 
ART 
antiretroviral therapy 
ASCO 
American Society of Clinical Oncology 
AST 
aspartate aminotransferase 
ASTCT 
American Society for Transplantation and Cellular Therapy 
AUC 
area under the concentration-time curve 
AUCinf 
area under the concentration-time versus time curve from time 0 to 
infinity 
AUClast 
area under the concentration-time curve from time 0 to time of last 
measurable concentration 
AUCtau,ss 
area under the steady state dose concentration-time curve over 
dosing interval tau 
AV 
atrioventricular 
BLRM 
Bayesian Logistic Regression Model 
BNP 
Brain natriuretic peptide 
BOR 
best overall response 
BP 
blood pressure 
Bpm 
beats per minute 
BUN 
blood urea nitrogen 
C1D1 
Cycle 1 Day 1 
C1D15 
Cycle 1 Day 15 
C2D15 
Cycle 2 Day 15 
C3D1 
Cycle 3 Day 1 
CD4+ 
Cluster of differentiation 8 positive 
CD8+ 
Cluster of differentiation 4 positive 
CEA 
cergutuzumab amunaleukin 
CEA-IL2v 
CEA-targeted IL-2 variant 
cfDNA 
cell free DNA 
CFR 
Code of Federal Regulations 
CHF 
congestive heart failure 

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Abbreviation 
Term 
CI 
confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CK 
creatine kinase 
CK-MB 
creatine kinase-muscle type, myocardial band 
CL 
total clearance of drug from eg, plasma 
Cmax 
maximum observed concentration 
CONSORT 
Consolidated Standards of Reporting Trials 
CR 
complete response 
CRC 
colorectal cancer 
CrCl 
creatinine clearance 
CRF 
case report form 
CRO 
contract research organization 
CRP 
C-reactive protein 
CRS 
cytokine release syndrome 
CSR 
clinical study report 
CT 
computed tomography/clinical trial 
CTC 
circulating tumor cells 
CTCAE 
Common Terminology Criteria for Adverse Events 
DCR 
disease control rate 
DCT 
data collection tool 
DILI 
drug-induced liver injury 
DLRM 
Dose Level Review Meeting 
DLT 
dose-limiting toxicity 
DMC 
Data Monitoring Committee 
DNA 
deoxyribonucleic acid 
DOR 
duration of response 
DU 
dispensable unit 
EC 
ethics committee 
ECG 
electrocardiogram 
ECHO 
echocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EC 
exclusion criteria 
EDP 
exposure during pregnancy 
EGFR 
epidermal growth factor receptor 
EMA 
European Medicines Agency 
EOI 
end of infusion 
EOS 
end of study 
EOT 
end of treatment 
EU 
European Union 
EWOC 
escalation with overdose control 
FAP 
fibroblast activation protein 
FAP-IL2v 
FAP-targeted IL-2 variant 

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Abbreviation 
Term 
FDA 
Food and Drug Administration (United States) 
FFPE 
formalin-fixed paraffin-embedded 
FIH 
first in human 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GGT 
gamma-glutamyl transferase 
GH 
Growth hormone 
GI 
gastrointestinal 
GM-CSF 
granulocyte-macrophage colony-stimulating factor 
HCV 
hepatitis C virus 
HER2 
human epidermal growth factor receptor 2 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus 
HNSTD 
highest non-severely toxic dose 
hPBMC 
human peripheral blood monmuclear cells 
hr 
hour 
HR 
heart rate 
HRT 
hormone replacement therapy 
IB 
Investigator’s Brochure 
IC 
inclusion criteria 
ICD 
informed consent document 
ICH 
International Council for Harmonisation 
ICIs 
immune checkpoint inhibitors 
ICU 
intensive care unit 
ID 
identification 
IF 
immunofluorescence 
IFN- 
interferon gamma 
IGF-1 
insulin-like growth factor 1 
IHC 
immunohistochemistry 
IL 
interleukin 
IMP 
investigational medicinal product 
IND 
Investigational New Drug 
INR 
international normalized ratio 
IP-10 
IFN-γ-inducible protein 10 
IP manual 
investigational product manual 
IPAL 
Investigational Product Accountability Log 
irAE 
immune-related adverse event 
IRB 
Institutional Review Board 
IRR 
Infusion-related reaction 
IRT 
Interactive Response Technology 
ISR 
injection site reaction 
IUD 
intrauterine device 
IUS 
intrauterine hormone-releasing system 

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Abbreviation 
Term 
IV 
intravenous 
IWR 
interactive Web-based response 
JAGS 
just another Gibbs sampler 
LBBB 
left bundle branch block 
LDH 
lactate dehydrogenase 
LFT 
liver function test 
LH 
luteinizing hormone 
LUC 
large unstained cells 
LVEF 
left ventricular ejection fraction 
mAb 
monoclonal antibody 
MABEL 
minimum anticipated biological effect level 
MAP 
meta-analytic-predictive 
MedDRA 
Medical Dictionary for Regulatory Activities 
MEK 
mitogen-activated protein kinase kinase 
MCMC 
Markov Chain Monte Carlo Methods 
mITT 
Modified-intent-to-treat 
MM 
metastatic melanoma 
MOA 
mechanism of action 
MRI 
magnetic resonance imaging 
msec 
millisecond 
MSS 
microsatellite-stable 
MTD 
maximum tolerated dose 
MUGA 
multigated acquisition scan 
N/A 
not applicable 
NAb 
neutralizing antibodies 
NCI 
National Cancer Institute 
NE 
non-evaluable 
NIMP 
non-investigational medicinal product 
NK 
natural killer 
NOAEL 
no observed adverse effect level 
NSAIDS 
nonsteroidal anti-inflammatory drugs 
NSCLC 
non-small cell lung cancer 
OR 
overall response 
ORR 
objective response rate 
OS 
overall survival 
OvCa 
ovarian cancer 
PBMC 
peripheral blood mononuclear cell 
PD 
pharmacodynamics(s)/progressive disease 
PD-1 
programmed cell death protein 1 
PD-L1 
programmed death-ligand 1 
PET 
positron emission tomography 
PFS 
progression-free survival 
PK 
pharmacokinetic(s) 

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Abbreviation 
Term 
PR 
partial response 
PRL 
prolactin 
PS 
performance status 
PT 
prothrombin time 
PTT 
partial thromboplastin time 
PVC 
premature ventricular contraction/complex 
Q1W 
once every week 
Q2W 
once every two weeks 
Q12W 
once every twelve weeks 
QTc 
corrected QT 
QTcB 
QTc corrected QT (Bazett method)using Bazett’s formula 
QTcF 
QTc corrected QT (Fridericia method)using Fridericia’s formula 
qual 
qualitative 
Rac 
accumulation ratio based on AUC (observed) 
RCC 
renal cell carcinoma 
RECIST 
Response Evaluation Criteria in Solid Tumors 
pSTAT5 
signal transducer and activator of transcription 5 (protein) 
rhIL-15 
recombinant human Interleukin-15 
RNA 
ribonucleic acid 
RO 
receptor occupancy 
RP2D 
recommended Phase 2 dose 
RR 
response rate 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SC 
subcutaneous 
SCCHN 
squamous cell head and neck carcinoma 
SD 
stable disease 
SoA 
schedule of activities 
SOC 
standard of care 
SOP 
standard operating procedure 
SRSD 
Single-reference safety document 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
t½ 
terminal phase half-life 
T4 
thyroxine 
TBili 
total bilirubin 
TGI 
tumor growth inhibition 
TIL 
tumor infiltrating lymphocytes 
TK 
toxicokinetics 
TNF 
tumor necrosis factor 
TNF- 
tumor necrosis factor- 
Tmax 
time to reach Cmax 
TME 
tumor microenvironment 
TSH 
thyroid-stimulating hormone 

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Abbreviation 
Term 
TT 
thrombin time 
TTP 
time to progression 
UC 
urothelial carcinoma 
ULN 
upper limit of normal 
US 
United States 
WBC 
white blood cell 
WOCBP 
woman of childbearing potential 

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