A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Phase: PHASE2
Conditions: Metastatic Solid Tumor
Sponsor: Gilead Sciences

CLINICAL STUDY PROTOCOL
Study Title:
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) 
in Subjects with Metastatic Solid Tumors
Study Acronym:
TROPiCS-03
Short Title:
Study of Sacituzumab Govitecan in Participants With Metastatic Solid 
Tumors
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
USA
IND Number:
115621
EU CT Number:
2024-513611-28
ClinicalTrials.gov 
Identifier:
NCT03964727
Indication:
Metastatic Solid Tumors
Protocol ID:
IMMU-132-11
Contact Information:
The medical monitor name and contact information will be provided 
on the Key Study Team Contact List.
Protocol 
Version/Date:
Amendment 5: 
17 December 2024
Amendment History:
Original:
16 January 2019 
Amendment 1:
12 September 2019
Amendment 2:
24 March 2021
Amendment 3: 
29 November 2021
Amendment 4: 
09 October 2023
Amendment 5: 
17 December 2024
A high-level summary of the changes in each amendment is 
provided in Appendix 17.11.
Country-specific 
Requirements:
Country-specific requirements, as applicable, are listed in 
Appendix 17.10.
This study will be conducted under United States Food and Drug Administration investigational 
new drug application regulations (21 Code of Federal Regulations Part 312); however, sites 
GILEAU 

located in the European Economic Area, the United Kingdom, and Switzerland are not included 
under the investigational new drug application and are not considered to be investigational new 
drug application sites.
This study will be conducted in compliance with this protocol and in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, and that are consistent with 
International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and applicable 
regulatory requirements.
The study will be conducted in accordance with European Union Clinical Trials Directive 
(2001/20/EC) and EU Regulation 536/2014.
CONFIDENTIALITY STATEMENT
The information contained in this document, particularly unpublished data, is the property or under control 
of Gilead Sciences, Inc., and is provided to you in confidence as an Investigator, potential Investigator, or 
consultant, for review by you, your staff, and an applicable institutional review board or independent ethics 
committee. The information is only to be used by you in connection with authorized clinical studies of the 
investigational drug described in the protocol. You will not disclose any of the information to others without 
written authorization from Gilead Sciences, Inc., except to the extent necessary to obtain informed consent 
from those persons to whom the drug may be administered.

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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Name of Sponsor/Company: Gilead Sciences, Inc.
Name of Investigational Product: sacituzumab govitecan (IMMU-132)
Name of Active Ingredient: sacituzumab govitecan
Protocol Number: IMMU-132-11
Phase: 2
Region(s): Global
Title of Study:
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with 
Metastatic Solid Tumors
Study Acronym: TROPiCS-03
Short Title: Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors 
Study Center(s): Up to 95 sites
Studied Period (years):
Date first subject enrolled: 12 Sep 2019
Estimated date last subject enrolled: 30 May 2023
Phase of development: 2
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Objectives and Endpoints: 
Primary Objective 
Assess the ORR of sacituzumab govitecan in 
subjects with metastatic solid tumors by 
Investigator's assessment according to the 
Response Evaluation Criteria in Solid 
Tumors Version 1.1 (RECIST 1.1) criteria. 
Secondary Objectives 
• 
Assess the ORR, dmation ofresponse 
(DOR), clinical benefit rate (CBR), and 
progression-free survival (PFS) of 
sacituzumab govitecan in subjects with 
metastatic solid tumors by blinded 
independent centrnl review (BICR) 
according to RECIST 1.1 criteria. 
• 
Assess the DOR, CBR, and PFS of 
sacituzumab govitecan in subjects with 
metastatic solid tumors by Investigator's 
assessment according to RECIST 1.1 
criteria. 
• 
Assess the OS of sacituzumab govitecan 
in subjects with metastatic solid tumors. 
• 
Assess the safety of sacituzumab 
govitecan in subjects with metastatic 
solid tumors. 
• 
Assess the PK and immunogenicity of 
sacituzumab govitecan in subjects with 
metastatic solid tumors. 
Exploratory Objectives 
Primary Endpoint 
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Objective response rate (ORR) according to 
RECIST 1.1 by Investigator's assessment. 
Secondary Endpoints 
• 
ORR, DOR, CBR, and PFS according to 
RECIST 1.1 by BICR. 
• 
DOR, CBR, and PFS, according to 
RECIST 1.1 by Investigator's 
assessment. 
• 
Overall smvival (OS). 
• 
Incidence of treatment-emergent adverse 
events (AEs) and clinical laborato1y 
abno1malities. 
• 
Semm concentrations of sacituzumab 
govitecan over time and incidence of 
anti-dmg antibody (ADA) to 
sacituzumab govitecan. 
Exploratory Endpoints 
____ ...,. __ 
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Study Design: 
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This is a multi-cohort, open-label, Phase 2 study designed to assess the efficacy and safety of 
sacituZUillab govitecan in adult subjects with metastatic solid tumors. Upon meeting the 
eligibility criteria, the subjects are treated with saciti.1Zl1Illab govitecan at 10 mg/kg via 
intravenous infusion on Days 1 and 8 of a 21-day cycle. The original protocol included the 
following coho1ts: non-small cell lung cancer (NSCLC; adenocarcinoma and squamous cell 
carcinoma [SCC]), head and neck squamous cell carcinoma (HNSCC), and endometrial 
carcmoma. 
With Amendment 3, this is a single stage coho1t evaluation for proof of concept (POC) with 
recalculation of sample sizes for all the coho1ts. An additional coho1t for small cell lung cancer 
(SCLC) has been added. The Sponsor will evaluate the totality of efficacy and safety data at 
the end of the POC stage independently for each of the coho1ts, and may potentially expand 
the HNSCC, endometrial carcinoma and SCLC coho1ts to emoll additional subjects up to a 
total sample size of 100 to 120 subjects in each selected coho1t . In addition, OS is included as 
a secondary endpoint and will be assessed for all coho1ts 
Sn.1dy modifications after implementation of Protocol Amendment 5 (PAS): 
Following implementation of PAS, subjects who are still receiving treatment may continue 
treatment as pait of the study for as long as they are deriving clinical benefit. Radiographic 
tumor assessments per protocol will be discontinued; however, treatment response should 
continue to be evaluated per standard of care. Info1mation on study diug adininistration and 
safety assessments will continue to be collected. Subjects who have discontinued treatment 
and were being followed for survival and subsequent therapy at the time of P A5 
implementation, will be discontinued from the study and survival follow-up with subsequent 
therapy info1mation will no longer be collected. 
At the completion of the study, subjects who were deriving benefit from saciti.1Zl1Illab 
govitecan may continue to receive treatment in a rollover sn.1dy (Sn.1dy IMMU-132-14) in 
locations where the study is available. 
Methodology: 
Baseline/Screening evaluations that must be perfo1med after providing written info1med 
consent and within 28 days prior to Cycle 1, Day 1 (ClDl ) include subject's medical and 
surgical histo1y, histology or cytology docUillentation, computed tomography (CT) or 
magnetic resonance imaging (MRI) imaging with intravenous (IV) contrast ( chest, abdomen, 
pelvis, and other areas of known/suspected involvement), unless known anaphylaxis to 
contrast and/or medically contraindicated (imaging options described below), complete 
physical examination with vital signs and Eastern Cooperative Oncology Group (ECOG) 
Perfonnance Score, electrocardiogram (ECG), complete blood count (CBC) with differential, 
routine sennn chemistries including liver function tests, lactate dehydi·ogenase (LDH), uric 
acid, hepatitis B and C testing, HIV testing, and pregnancy test in women of childbearing 
potential. Routine cheinistries and liver function tests need to be repeated for C 1 D 1 if they 
were obtained for Screening > 72 hours prior to ClDl dosing. In females of childbearing 
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potential, a negative sennn pregnancy test during screening and a negative urine pregnancy 
test is required at baseline prior to study treatment administrntion on ClDl . The urine 
pregnancy test at baseline (prior to study treatment administrntion on ClDl ) does not need to 
be conducted if the sernm pregnancy at screening was perfonned within 72 hours before study 
ti·eatment administi·ation on C 1 D 1. 
All subjects who previously failed screening may be rescreened only once. 
Twelve-lead ECG will be obtained at baseline and prior to the ClDl infusion. Abnonnal 
findings should be evaluated as clinically indicated, including repeated ECGs. ECGs may be 
done at other timepoints during the study if clinically indicated. 
Tumor blocks (preferably obtained within 12 months of study entiy if clinically feasible) or 
20 newly sectioned unstained slides ( 6 slides minimum) of archived biopsy/surgical specimens 
are requested. A baseline biopsy is required if archival tissue is not available. Fine needle 
aspirates and bone biopsies are not suitable samples. These specimens should be submitted 
within the 28-day screening period, after the subject provides written infonned consent. 
Sennn samples will be collected from all subjects for PK and immunogenicity assessments. A 
blood sample will be collected for UGTlAl genotype. 
Blood samples will be collected from all subjects for biomarker analyses. 
Adverse events (AEs), concomitant medications (continued, changed), and hematology and 
chemistry blood work will be obtained during eve1y study visit with appropriate follow-up of 
clinically significant abnonnal laborato1y assessments or AEs. 
Response assessments by CT or MRI scan with IV conu-ast ( chest, abdomen, and pelvis with 
scanning of other regions including brain MRI as clinically indicated) unless known 
anaphylaxis to conti·ast and/or medically contraindicated. If the use of IV conu-ast is medically 
conti·aindicated for a subject, 1 of the following options may be used (listed in order of 
preference): CT without conti·ast, MRI without conu-ast, or attempt to desensitize the subject 
with steroids. For each subject, the same imaging technique should be used throughout the 
study for tumor assessment. If a subject had brain lesions at study entiy, brain MRI will be 
needed at all assessments. The timing of imaging is based on calendar time from the date of 
ClDl. Scans will be perfonned for all subjects at baseline and eve1y 6 weeks for the first 
6 months after ClDl and then eve1y 9 weeks thereafter until the occmTence of radiologic 
progression of disease (progressive disease; PD), as per RECIST 1.1, requiring discontinuation 
of ti·eatment. Dose delays and cycle delays should not result in delays in the timing of imaging. 
For subjects with evidence of complete response (CR) or partial response (PR), a confmnato1y 
scan must be obtained at least 4 to 6 weeks after initial documentation of CR or PR. 
Subjects will be u-eated until PD (according to RECIST 1.1 by Investigator's assessment), 
unacceptable toxicity, study withdrawal, or death, whichever comes first. However, u-eatment 
may be continued beyond PD if there is evidence of clinical benefit per the Investigator and 
the subject is tolerating study u-eatment. The following clinical criteria should be met for 
subjects to continue to receive ti·eatment beyond the Investigator-assessed progression: 
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•
Absence of symptoms and signs indicating clinically significant progression of disease.
•
No decline in performance status.
•
Absence of symptomatic rapid disease progression requiring urgent medical intervention 
(eg, symptomatic pleural effusion, spinal cord compression).
Sponsor consultation is required before subjects initiate the treatment beyond progression. If 
this occurs, the subject will remain in the study and continue to be monitored according to the 
protocol schedule of assessments).
Subjects who discontinue treatment because of toxicity will continue with radiologic response 
assessments per protocol-required schedule, until PD or initiation of new therapy. The reason 
for treatment discontinuation will be documented and any treatment-related AEs or clinically 
significant abnormal laboratory values at that time will be followed until resolution or 
stabilization.
The EOT Visit will be conducted within 30 days of the date when the decision is made to 
discontinue treatment. A Safety Follow-up Visit will be conducted 30 days after the last 
treatment dose. If the EOT Visit and Safety Follow-up Visit coincide within 2 weeks of each 
other, the same assessments may be utilized for both events. Subjects will then be followed 
every 12 weeks for survival, unless the subject explicitly indicates a desire to forego survival 
follow-up to their study Investigator. Subjects will be followed until death, withdrawal of 
consent, loss to follow-up, Sponsor-terminated study or completion of survival follow-up 
(24 months after the last subject is dosed), whichever occurs first.
For subjects who are lost to follow-up, study staff may use public records (eg, public health 
records) to obtain information about survival status where allowable by local regulation.
Following implementation of PA5, subjects who previously discontinued treatment will no 
longer be followed for survival follow-up and subsequent therapy and will discontinue the 
study.
The end of study for a subject occurs when they have completed all periods of the study 
including long-term survival follow-up due to the following reasons: death, the subject 
withdraws consent, there is documented loss to follow-up of the subject, or the Sponsor 
terminated the study, whichever comes first. The end of the entire study for all subjects is 
defined as the date on which the last subject remaining on study completes the last study 
visit/call/survival follow-up or when the Sponsor decides to end the study. The Sponsor 
reserves the right to terminate the study at any time for any reason (including safety). 
National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 
(NCI-CTCAE v5.0) toxicity grades will be used to classify safety evaluations and AEs, 
including serious adverse events (SAEs). SAEs must be reported to the Sponsor’s designee 
within 24 hours of the event, and treatment-related AEs and SAEs will be followed until 
recovery or stabilization in the event of residual effects. Abnormal clinically significant 
laboratory values must be repeated within 48 hours and followed until resolution.
Following implementation of PA5:
•
Subjects may continue treatment as part of the study, for as long as they are deriving 

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clinical benefit. After they meet one of the criteria for treatment discontinuation, they will 
have an EOT visit and a 30-Day Safety Follow-up Visit. There will be no additional 
assessments including smvival follow-up and subsequent therapy collection. 
• 
Subjects will have the end of study at the same time as the EOT visit. However, if at the 
time of an EOT visit, subjects have unresolved AEs, the end of study may be delayed until 
all AEs have been resolved or stabilized. 
Number of Subjects (Planned): 
Diagnosis and Main Criteria for Inclusion: 
Target Population: 
Adult subjects with histologically documented advanced or metastatic NSCLC 
(adenocarcinoma and SCC), HNSCC, endometrial carcinoma, or SCLC. All subjects must 
meet the eligibility criteria described in the following inclusion criteria and exclusion criteria. 
Inclusion Criteria: 
Subjects meeting all the following inclusion criteria at Screening will be eligible for 
paiiicipation in the study. 
1) Female or male subjects, ~ 18 years of age, who are able to understand and give written 
info1med consent. 
2) Subjects with the following histologically documented metastatic (Ml, Stage IV) or locally 
advanced solid tumors. 
a) NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based 
chemotherapy and programmed death-(ligand) 1 (PD-(L)l) directed therapy given 
sequentially (in either order) or in combination. These agents could have been taken as 
monotherapy or in combination with other agents. If subjects have had 
recmTence/relapse or lack of response within 6 months of completing chemotherapy 
with or without PD-(L)l directed therapy for locally advanced disease, that line of 
therapy may be counted for eligibility. 
b) HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)l 
directed thera 
iven se uentiall 
in either order or in combination. These a ents 
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could have been taken as monotherapy or in combination with other agents. No more 
than 3 prior lines of systemic treatment is allowed.
c) Endometrial carcinoma that has progressed after prior platinum-based chemotherapy 
and anti- PD-(L)1 directed therapy given sequentially (in either order) or in 
combination. These agents could have been taken as monotherapy or in combination 
with other agents. No more than 3 prior lines of systemic treatment is allowed.
Endometrial carcinoma with any histology including microsatellite instability-high 
/mismatch repair deficient and microsatellite stable (MSI-h/dMMR and MSS) are 
allowed.
d) Extensive stage SCLC that has progressed after prior platinum-based chemotherapy 
and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is 
allowed (re-challenge with the same initial regimen is not allowed).
3) ECOG Performance Status score of 0 or 1 (see Appendix 17.2).
4) Adequate hematologic counts without transfusional or growth factor support within 
2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count 
(ANC) ≥ 1,500/mm3, and platelets ≥ 100,000/µL).
5) Adequate hepatic function (bilirubin ≤ 1.5 institutional upper limit of normal [IULN], 
aspartate aminotransferase [AST], and alanine aminotransferase [ALT] ≤ 2.5 × IULN or 
≤ 5 × IULN if known liver metastases and serum albumin > 3 g/dL).
6) Creatinine clearance ≥ 30 mL/min as assessed by Cockcroft-Gault (see Appendix 17.3).
7) Subjects must have at least a 3-month life expectancy.
8) Have measurable disease by CT or MRI scan as per RECIST 1.1 criteria (see 
Appendix 17.4). Tumor lesions situated in a previously irradiated area may be utilized if 
they are considered measurable and PD has been demonstrated in such lesions.
9) Male subjects and female subjects of childbearing potential who engage in heterosexual 
intercourse must agree to use protocol-specified method(s) of contraception as described in 
Appendix 17.5.
10) Tumor blocks (preferably obtained within 12 months of study entry if clinically feasible) 
or 20 newly sectioned unstained slides (6 slides minimum) of archived biopsy/surgical 
specimens are requested. A baseline biopsy is required if archival tissue is not available. 
Fine needle aspirates and bone biopsies are not suitable samples. These specimens should 
be submitted within the 28-day screening period, after the subject provides written 
informed consent.
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria at Screening will not be enrolled in 
the study.
1)  Positive serum pregnancy test (Appendix 17.5) or women who are lactating.

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2) Are currently participating in or has participated in a study of an investigational agent or 
using an investigational device within 4 weeks prior to the first dose of study drug. 
Subjects participating in observational studies are eligible.
3) Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have 
had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 
2 weeks prior to study Day 1.
4) Have not recovered (ie, ≤ Grade 1) from AEs due to a previously administered agent.
•
Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are exceptions to this 
criterion and may qualify for the study.
•
Note: If subjects underwent major surgery, they must have recovered adequately from 
the toxicity and/or complications from the intervention prior to starting study drug.
•
Note: Subjects with Grade ≤ 2 immune-mediated toxicities (except colitis) related to 
immunotherapy and/or radiation treatment that are long lasting, but stable on treatment 
and not requiring agents that are excluded by this protocol may qualify for the study.
5) Have previously received topoisomerase I inhibitors (for SCLC cohort: Etoposide with 
platinum combination in first-line setting is allowed).
6) Have an active second malignancy.
•
Note: Subjects with a history of malignancy that has been completely treated, with no 
evidence of active cancer for 3 years prior to enrollment, or subjects with surgically 
cured tumors with a low risk of recurrence, may be enrolled.
7) Have known active central nervous system (CNS) metastases and/or carcinomatous 
meningitis. Subjects with previously treated brain metastases may participate provided 
they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and 
all neurologic symptoms have returned to baseline, no evidence of new or enlarging brain 
metastases and are taking ≤ 20 mg/day of prednisone or its equivalent. All subjects with 
carcinomatous meningitis are excluded regardless of clinical stability.
8) Have active cardiac disease, defined as:
•
Myocardial infarction or unstable angina pectoris within 6 months of Day 1.
•
History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular 
fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring 
anti-arrhythmic medications (except for atrial fibrillation that is well controlled with 
anti-arrhythmic medication); history of QT interval prolongation.
•
New York Heart Association (NYHA) Class III or greater congestive heart failure or 
left ventricular ejection fraction of < 40%.
9) Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease), 
immune-mediated colitis, or gastrointestinal (GI) perforation within 6 months of C1D1.
10) Have an active infection requiring IV antibiotics.

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11) Have positive human immunodeficiency virus (HIV)-1 or HIV-2 antibody with detectable 
viral load or taking medications that may interfere with SN-38 (the active metabolite of 
sacituzumab govitecan).
12) Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), subjects with a detectable 
viral load will be excluded.
•
Subjects who test positive for hepatitis B surface antigen (HBsAg). Subjects who test 
positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by 
quantitative polymerase chain reaction (PCR) for confirmation of active disease.
•
Subjects who test positive for HCV antibody. Subjects who test positive for HCV 
antibody will require HCV RNA by quantitative PCR for confirmation of active 
disease. Subjects with a known history of HCV or a positive HCV antibody test will 
not require an HCV antibody at screening and will only require HCV RNA by 
quantitative PCR for confirmation of active disease.
13) Have other concurrent medical or psychiatric conditions that, in the Investigator’s opinion, 
may be likely to confound study interpretation or prevent completion of study procedures 
and follow-up examinations.
14)  Impending need for palliative radiation therapy or surgery for pathological fractures 
and/or for medullary compression within 4 weeks prior to initiating study treatment.
15) Additional cohort-specific exclusion criteria:
NSCLC cohort (adenocarcinoma and SCC):
a) Clinically severe pulmonary compromise resulting from intercurrent pulmonary 
illnesses including, but not limited to, any underlying pulmonary disorder (ie, 
pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic 
obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any 
autoimmune, connective tissue, or inflammatory disorders with pulmonary 
involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior 
pneumonectomy.
HNSCC cohort:
b) Subjects with nasopharynx carcinoma.
c) Subjects who had progressive disease within 6 months of completion of curative 
therapy.
Endometrial carcinoma cohort:
d) Subjects who have carcinosarcoma (malignant mixed Mullerian tumor), endometrial 
leiomyosarcoma, and/or endometrial stromal sarcomas.
Small cell lung cancer cohort:
e) Subjects who never received platinum-containing regimen for SCLC.
f)
Limited-stage subjects who are candidates for local or regional therapy.

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Investigational product, dosage, and mode of administration:
Sacituzumab govitecan will be administered at 10 mg/kg as an IV infusion on Days 1 and 8 of 
a 21-day cycle until PD, unacceptable toxicity, or withdrawal of consent. Treatment beyond 
PD is permitted if there is evidence of clinical benefit per the Investigator and the subject is 
tolerating study treatment. The clinical criteria for treatment beyond PD are described in the 
Methodology section of the Synopsis.
Statistical Methods:
This study was originally designed to limit enrollment to subjects with elevated TROP-2 
expression. In Amendment 2, the enrollment criterion for elevated TROP-2 expression was 
removed, and the study was expanded to include subjects with any level of TROP-2 
expression. Clinical activity will be correlated with TROP-2 expression assessed 
retrospectively.
In Amendment 3, the primary endpoint is ORR according to RECIST 1.1 by Investigator 
assessment. Secondary endpoints include ORR, DOR, CBR (defined as complete response + 
partial response + stable disease [CR + PR + SD] for at least 6 months), and PFS according to 
RECIST 1.1 by BICR; DOR, CBR, and PFS according to RECIST 1.1 by the Investigator 
assessment; OS; incidence of treatment-emergent AEs and clinical laboratory abnormalities; 
and serum concentrations of sacituzumab govitecan and incidence of ADAs to sacituzumab 
govitecan. Summary tables and listings will be prepared using SAS®. Continuous data will be 
summarized using descriptive statistics: n, mean, median, standard deviation, minimum, and 
maximum. Categorical data will be summarized using frequency counts and percentages. Data 
listings will be created to support tables and figures. Any statistical analyses impacted by the 
coronavirus disease 2019 (COVID-19) pandemic will be detailed in the statistical analysis plan 
(SAP).
Statistical analyses will be performed using SAS® (SAS Institute, Version 9.2 or later, Cary, 
NC) and other software.
In Amendment 3, the sample size for the POC stage was not based on formal power 
calculation but to ensure the accuracy for the estimation of ORR. For each cohort of NSCLC, 
assuming the true ORR is 25%, a sample size of 30 subjects will ensure the half-width of the 
95% CI is ≤ 0.155; for the HNSCC cohort, assuming the true ORR is 22%, a sample size of 
30 subjects in the POC stage will ensure the half-width of the 95% CI is ≤ 0.148; for the 
endometrial carcinoma cohort, assuming the true ORR is 23%, a sample size of 35 subjects 
will ensure the half-width of the 95% CI is ≤ 0.139; for the SCLC cohort, assuming the true 
ORR is 25%, a sample size of 40 subjects will ensure the half-width of the 95% CI is ≤ 0.134.
Once the minimal number of responses (CR or PR) are observed at the end of POC stage in 
any of the cohorts of HNSCC, endometrial carcinoma or SCLC, the Sponsor may evaluate the 
totality of data and choose to expand the specific cohort and enroll approximately a total of 
100 to120 subjects. This total sample size of 100 to 120 subjects in the cohort provides 
adequate power to reject the null hypothesis for ORR 𝐻0:𝑟≤𝑟0 versus the alternative 

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hypothesis H1 :r = r 1 , where r 0 is the futile response rate based on historical control data and 
r 1 is the target response rate. 
The minimal number of responses that are required to trigger the potential expansion, the 
specific power for each sample size, along with the assumed target ORR r 1 and null r 0 , are 
provided by coho1t in the table below. The power is calculated using an exact binomial test 
with a one-sided a, of 0.025. 
-
I -
- -
-
-
-
- -
-
-
- -
-
-
- - - -
-
- - - -
-
- - - -
-
- - - -
-
-
- - - -
-
- - - -
-
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TABLE OF CONTENTS
PROTOCOL SYNOPSIS................................................................................................................................................3
TABLE OF CONTENTS..............................................................................................................................................14
LIST OF IN-TEXT TABLES .......................................................................................................................................16
LIST OF IN-TEXT FIGURES......................................................................................................................................16
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS...............................................................................17
1.
INTRODUCTION................................................................................................................................................20
1.1.
Sacituzumab Govitecan Background ......................................................................................................20
1.1.1.
Mechanism of Action of Sacituzumab Govitecan.................................................................20
1.1.2.
Nonclinical Experience .........................................................................................................20
1.1.3.
Clinical Experience ...............................................................................................................22
1.1.4.
Rationale for Dose Regimen .................................................................................................26
1.2.
Study Rationale .......................................................................................................................................26
1.2.1.
Potential Benefits...................................................................................................................28
1.2.2.
Benefit-Risk Assessment.......................................................................................................29
2.
STUDY OBJECTIVES AND ENDPOINTS .......................................................................................................30
3.
INVESTIGATIONAL PLAN ..............................................................................................................................31
4.
STUDY PROCEDURES......................................................................................................................................33
4.1.
Informed Consent ....................................................................................................................................33
4.2.
Screening Evaluations .............................................................................................................................33
4.3.
Procedures During Treatment..................................................................................................................35
4.3.1.
Treatment After Progression .................................................................................................37
4.4.
End of Treatment Visit ............................................................................................................................37
4.5.
30-Day Safety Follow-Up Visit...............................................................................................................38
4.6.
Treatment Discontinuation ......................................................................................................................39
4.6.1.
Lost to Follow-up ..................................................................................................................40
4.7.
Safety/End of Treatment and Survival Follow-up...................................................................................40
4.8.
End of Study............................................................................................................................................40
4.9.
Sample Storage........................................................................................................................................41
5.
STUDY EVALUATIONS....................................................................................................................................42
5.1.
Medical History and Demographic/Baseline Characteristics..................................................................49
5.2.
Prior and Concomitant Medication Assessments....................................................................................49
5.3.
Other Study Evaluations..........................................................................................................................49
6.
TARGET POPULATION ....................................................................................................................................50
6.1.
Screen Failures ........................................................................................................................................50
6.2.
Subject Inclusion Criteria........................................................................................................................50
6.3.
Subject Exclusion Criteria.......................................................................................................................52
7.
TREATMENT OF SUBJECTS............................................................................................................................55
7.1.
Description of Study Drug.......................................................................................................................55
7.2.
Concomitant Medications........................................................................................................................55
7.3.
Treatment Compliance ............................................................................................................................55
7.4.
Randomization and Blinding...................................................................................................................56
7.5.
Treatment of Sacituzumab Govitecan-Associated Toxicities .................................................................56
7.5.1.
Preventative Medications ......................................................................................................56

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7.5.2.
Management of Sacituzumab Govitecan Toxicities..............................................................57
7.6.
Drug Interactions.....................................................................................................................................61
7.6.1.
UGT1A1 Inhibitors ...............................................................................................................61
7.6.2.
UGT1A1 Inducers .................................................................................................................61
8.
STUDY DRUG MATERIALS AND MANAGEMENT.....................................................................................62
8.1.
Study Drug...............................................................................................................................................62
8.2.
Study Drug Packaging and Labeling.......................................................................................................62
8.3.
Study Drug Storage .................................................................................................................................62
8.4.
Study Drug Preparation ...........................................................................................................................62
8.5.
Administration.........................................................................................................................................62
9.
ASSESSMENT OF EFFICACY..........................................................................................................................63
10.
ASSESSMENT OF SAFETY ..............................................................................................................................64
10.1.
Safety Parameters ....................................................................................................................................64
10.1.1.
Clinical Laboratory Investigations ........................................................................................64
10.1.2.
Vital Signs .............................................................................................................................65
10.1.3.
Electrocardiogram .................................................................................................................65
10.1.4.
Physical Examinations, Body Weight, and Height ...............................................................65
10.1.5.
ECOG Performance Status....................................................................................................65
10.2.
Adverse and Serious Adverse Events......................................................................................................65
10.2.1.
Definition of Adverse Events ................................................................................................66
10.2.2.
Adverse Event Reporting and Assessment............................................................................67
10.2.3.
Reporting Deaths...................................................................................................................71
10.2.4.
Reporting Exposure During Pregnancy.................................................................................71
10.2.5.
Investigator Immediate Reporting Requirements..................................................................72
10.2.6.
Investigator Notification to Local Institutional Review Boards............................................72
10.2.7.
Sponsor Responsibilities .......................................................................................................72
10.3.
Pharmacokinetics Evaluations.................................................................................................................73
10.4.
Immunogenicity (Anti-drug Antibodies) Evaluations.............................................................................73
10.5.
UGT1A1 Genotype .................................................................................................................................73
10.6.
Biomarker Samples to Address the Study Objectives.............................................................................73
11.
STATISTICS........................................................................................................................................................77
11.1.
Determination of Sample Size.................................................................................................................77
11.2.
Efficacy Endpoint Definitions and Analyses ..........................................................................................79
11.3.
Safety Analyses .......................................................................................................................................80
11.4.
Pharmacokinetics Analyses.....................................................................................................................81
11.5.
Immunogenicity (Anti-Drug Antibodies) Analyses ................................................................................81
12.
ADMINISTRATIVE AND ETHICAL REQUIREMENTS ................................................................................82
12.1.
Good Clinical Practice.............................................................................................................................82
12.2.
Ethical Considerations.............................................................................................................................82
12.3.
Subject Information and Consent ............................................................................................................83
12.4.
Protocol Compliance ...............................................................................................................................83
12.5.
Site Monitoring and On-Site Audits........................................................................................................84
12.6.
Subject Data Protection ...........................................................................................................................84
12.7.
Financial Disclosure ................................................................................................................................85
12.8.
Sponsor Discontinuation Criteria ............................................................................................................86
13.
QUALITY CONTROL AND QUALITY ASSURANCE ...................................................................................87
14.
DATA HANDLING AND RECORD KEEPING................................................................................................88
14.1.
Electronic Case Report Forms (eCRFs) ..................................................................................................88

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14.2.
Retention of Records ...............................................................................................................................88
15.
PUBLICATION POLICY....................................................................................................................................89
16.
REFERENCES.....................................................................................................................................................90
17.
APPENDICES......................................................................................................................................................94
17.1.
Investigator Signature Page.....................................................................................................................95
17.2.
Performance Status Criteria.....................................................................................................................96
17.3.
Cockcroft-Gault Formula ........................................................................................................................97
17.4.
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1................................................................98
17.5.
Pregnancy Precautions, Definitions of Childbearing Potential, and Contraceptive 
Requirements.........................................................................................................................................101
17.6.
UGT1A1 Inhibitors and Inducers..........................................................................................................105
17.7.
Disaster and Public Health Emergency Risk Assessment and Mitigation Plan ....................................106
17.8.
Marketing Authorization Status of Study Interventions........................................................................109
17.9.
Risk Factors for Febrile Neutropenia ....................................................................................................110
17.10. Country-Specific Requirements ............................................................................................................111
17.11. Amendment History ..............................................................................................................................112
17.11.1.
Amendment 5 (17 December 2024) ....................................................................................112
17.11.2.
Amendment 4 (09 October 2023 ).......................................................................................113
17.12. Sponsor Signature Page.........................................................................................................................114
LIST OF IN-TEXT TABLES
Table 1.
Summary of Mean Pharmacokinetic Parameters (± Standard Deviation) of 
Sacituzumab Govitecan and Free SN-38.................................................................................23
Table 2.
Schedule of Assessments/Study Calendar (Before Implementation of PA5)..........................43
Table 3.
Modified Schedule of Assessments/Study Calendar (After Implementation of PA5) ............47
Table 4.
Guidance for Premedication and Prophylaxis for Toxicities Associated With 
Sacituzumab Govitecan ...........................................................................................................56
Table 5.
Sacituzumab Govitecan Dose Reduction Schedule.................................................................60
Table 6.
Recommended Dose Modification Schedule for Sacituzumab Govitecan..............................60
Table 7.
Grading for Adverse Events Not Listed in NCI-CTCAE........................................................69
Table 8.
Expansion Stage Power Consideration for Selected Cohorts..................................................78
LIST OF IN-TEXT FIGURES
Figure 1.
Study IMMU-132-11 Schema .................................................................................................31

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
5-HT3
5-hydroxytryptamine
ADA
Anti-drug antibody
ADC
Antibody-drug conjugate
AE
Adverse event
ALP
Alkaline phosphatase
ALT
Alanine aminotransferase
ANC
Absolute neutrophil count
ASCO
American Society of Clinical Oncology
AST
Aspartate aminotransferase
AUC
Area under the plasma concentration-time curve
β-hCG
Beta-human chorionic gonadotropin
BICR
Blinded independent central review
BUN
Blood urea nitrogen
C1D1
Cycle 1, Day 1
Cmax
Maximum plasma concentration
CBC
Complete blood count
CBR
Clinical benefit rate
CFR
Code of Federal Regulation
CI
Confidence interval
CNS
Central nervous system
CO2
Carbon dioxide
CONSORT
Consolidated Standards of Reporting Trials
COVID-19
Coronavirus disease 2019
CPS
Combined positive score
CR
Complete response
CT
Computed tomography 
dMMR
Mismatch repair deficient
DNA
Deoxyribonucleic acid
DOR
Duration of response
ECG
Electrocardiogram
EDC
Electronic data collection
ECOG
Eastern Cooperative Oncology Group
eCRF
Electronic case report form
EMA
European Medicines Agency
EOI
End of infusion
EOT
End of treatment
EU
European Union
EU CT
European Clinical Trials Database 

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FDA
Food and Drug Administration
FSH
Follicle-stimulating hormone
GCP
Good Clinical Practice
G-CSF
Granulocyte-colony stimulating factor
GI
Gastrointestinal
GLP
Good Laboratory Practice
HBc
Hepatitis B core antibody
HBsAg
Hepatitis B surface antigen
HBV
Hepatitis B virus
HCO3
Bicarbonate
HCV
Hepatitis C virus
HED
Human equivalent dose
HER2−
Human epidermal growth factor receptor 2-negative
HIPAA
Health Insurance Portability and Accountability Act of 1996
HIV
Human immunodeficiency virus
HNSCC
Head and neck squamous cell carcinoma
HR+
Hormone receptor positive
IC50
Concentration of drug required for 50% inhibition
ICH
International Council for Harmonization
IEC
Independent ethics committee
IO
Immuno-oncology
IgG
Immunoglobulin G
IND
Investigational new drug
IRB
Institutional review board
IULN
Institutional upper limit of normal
IV
Intravenous
LD
Longest diameter
LDH
Lactate dehydrogenase
M1
Metastatic, Stage IV
MedDRA
Medical Dictionary for Regulatory Activities
MRI
Magnetic resonance imaging
MSI-H
Microsatellite instability-high 
MSS
Microsatellite stable
MTD
Maximum tolerated dose
mTNBC
Metastatic triple-negative breast cancer
mUC
Metastatic urothelial cancer
NCI-CTCAE
National Cancer Institute-Common Terminology Criteria for Adverse Events
NK1
Neurokinin 1
NOAEL
No-observable adverse effect level
NSCLC
Non-small cell lung cancer

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NYHA
New York Heart Association
ORR
Objective response rate
OS
Overall survival
PA5
Protocol Amendment 5
PC-3
Epithelial tumor-prostate
PCP
Primary care physician
PCR
Polymerase chain reaction
PD
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
POC
Proof of concept
PR
Partial response
PT
Preferred Term
QTc
Corrected QT interval
QTcF
Corrected QT interval using Fridericia’s formula
RBC
Red blood cell
RECIST 1.1
Response Evaluation Criteria in Solid Tumors Version 1.1
RNA
Ribonucleic acid
SAE
Serious adverse event
SAP
Statistical analysis plan
SC
Subcutaneous
SCC
Squamous cell carcinoma
SCLC
Small cell lung cancer
SD
Stable disease
SOC
System Organ Class
SUSAR
Suspected unexpected serious adverse reaction
Tmax
Maximum plasma concentration
TACSTD
Tumor-associated calcium signal transducer
TID
Three (3) times per day
TMB-H
Tumor mutational burden-high
TNBC
Triple-negative breast cancer
TROP-2
Trophoblastic cell-surface antigen-2
UC
Urothelial cancer
UGT1A1
Uridine diphosphate -glucuronosyltransferase 1A1
US
United States
USP
United States Pharmacopoeia
WBC
White blood cell

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1.
INTRODUCTION
1.1.
Sacituzumab Govitecan Background
1.1.1.
Mechanism of Action of Sacituzumab Govitecan
Sacituzumab govitecan is an antibody-drug conjugate (ADC) composed of the following 
3 components:
1) The humanized monoclonal antibody, hRS7 IgG1κ, which binds to trophoblastic cell-surface 
antigen-2 (TROP-2), a transmembrane calcium signal transducer that is overexpressed in 
many epithelial cancers, including triple-negative breast cancer (TNBC).
2) The camptothecin-derived agent SN-38, a topoisomerase I inhibitor.
3) A hydrolyzable linker, with the company designation as CL2A, that links the humanized 
monoclonal antibody to SN-38.
Binding of TROP-2 by the parental RS7 antibody has been shown to result in internalization and 
processing of the antibody by the targeted cells {Shih 1994, Stein 1995}. Because of its 
hydrolyzable linker, sacituzumab govitecan will release its SN-38 payload both intra- and 
extracellularly in the tumor microenvironment {Goldenberg 2015, Govindan 2013}. 
Sacituzumab govitecan delivers significantly greater amounts of SN-38 to a TROP-2-expressing 
tumor than conventional irinotecan chemotherapy {Sharkey 2015}. The extracellular release of 
SN-38 from sacituzumab govitecan also allows for bystander killing of TROP-2 negative tumor 
cells {Lopez 2020, Perrone 2020, Zeybek 2020}. Thus, sacituzumab govitecan can deliver 
cytotoxic chemotherapy to tumors, including adjacent cancer cells, in concentrations that are 
higher than those with standard chemotherapy and may reduce toxic effects in normal tissues that 
do not express the target.
For further information on sacituzumab govitecan, refer to the current Investigator’s Brochure.
1.1.2.
Nonclinical Experience
1.1.2.1.
Pharmacology
In vitro cytotoxicity of sacituzumab govitecan was assessed in multiple cell lines representative 
of several different epithelial tumors; PC-3 (prostate), Calu-3, COLO 205, Capan-1, SK-MES-1, 
and BxPC-3. In general, the concentration of drug required for 50% inhibition (IC50) values 
ranged from 1.95 nM to 23.14 nM {Cardillo 2011}.
The antitumor activity and significant inhibition of tumor growth was shown in various epithelial 
cancer xenograft models including non-small cell lung cancer (NSCLC), colorectal cancer, 
pancreatic cancer, and triple-negative breast cancer (TNBC) when sacituzumab govitecan was 
compared to saline or unconjugated antibody controls {Cardillo 2015, Cardillo 2011, Goldenberg 
2015}.

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1.1.2.2.
Pharmacokinetics
Toxicokinetic analysis of the 3-month repeat-dose study in cynomolgus monkeys using validated 
assays showed a dose-proportional exposure (maximum plasma concentration [Cmax] and area 
under the curve [AUC]) to sacituzumab govitecan, total antibody, total SN-38, and free SN-38 
with no relevant gender differences after the first dose. Serum half-life was estimated in recovery 
animals and ranged from 67.3 to 152 hours. On average, the amount of free SN-38 in circulation 
was low, < 3% free SN-38 compared with the total SN-38 bound to sacituzumab govitecan. This 
confirms that the majority of SN-38 administered as sacituzumab govitecan remains bound to the 
ADC in serum and is not circulating as the free cytotoxic payload. The inactive metabolite, 
SN-38G, readily appeared in serum with a mean time to the maximum plasma concentration 
(Tmax) ranging from 4 to 12 hours.
1.1.2.3.
Toxicology
In acute toxicity studies in Swiss-Webster mice, sacituzumab govitecan at doses of up to 
750 mg/kg/dose (ie, cumulative doses of up to 1,500 mg/kg) caused minimal loss (< 10%) in 
body weight. There was no evidence of hematological toxicity and no abnormal histology 
findings. Transient increases in hepatic transaminases were observed, which had returned to 
normal by the end of the study.
In cynomolgus monkeys, sacituzumab govitecan administered at 50 mg/kg/dose (human 
equivalent dose [HED] = 16 mg/kg/dose) for 4 treatment cycles (Days 1 and 8 of a 21-day cycle) 
was considered a no-observable adverse effect level (NOAEL) and 120 mg/kg/dose administered 
3 days apart was associated with lethality. In general, the observed toxicities were 
dose-dependent and considered reversible. Target organs included the female reproductive tract; 
skin (hair loss, pigmentation); kidney (periarteritis); lymphoid organs (lymphoid depletion); bone 
marrow (reduced cellularity) with concomitant reductions in red blood cells (RBCs), white blood 
cells (WBCs), and platelets; and the gastrointestinal (GI) tract (necrosis, erosions, inflammation, 
fibrosis, hemorrhage, edema).
Local tolerance was evaluated in the Good Laboratory Practice (GLP)-compliant monkey 
studies. Although changes were observed at the injection site, the study pathologist interpreted 
these findings as related to procedural trauma and not the test article. These changes consisted of 
mild to moderate perivascular hemorrhage, moderate hemorrhage in the dermis and subcutis, and 
minimal to mild perivascular mixed cell infiltration.
SN-38 was negative for mutagenicity in a bacterial reverse mutation test and was found to be 
clastogenic in an in vitro mammalian cell micronucleus test. Neither the carcinogenicity, nor 
effects of sacituzumab govitecan on fertility, early embryonic development or prenatal and 
postnatal development have been assessed. However, SN-38 is a camptothecin and hence might 
be carcinogenic. Furthermore, SN-38 is a known developmental toxicant {CAMPTOSAR 2020}.

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1.1.3.
Clinical Experience
Sacituzumab govitecan is approved in several countries and regions including the US, Canada, 
Australia, Great Britain, Europe, Asia, and Switzerland, for the treatment of adult patients with 
unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have 
received 2 or more prior therapies, at least 1 of them for metastatic disease and for the treatment 
of adult patients with unresectable locally advanced or metastatic hormone receptor positive 
(HR+)/human epidermal growth factor receptor 2-negative (HER2−; immunohistochemistry 
[IHC] 0, IHC 1+, or IHC 2+/in-situ hybridization [ISH]−) breast cancer who have received 
endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
Clinical data are available for 3 clinical studies (2 completed and 1 ongoing) in which 
795 patients were treated with sacituzumab govitecan:
•
Study IMMU-132-01, a Phase 1/2, open-label, basket study in patients with metastatic 
epithelial cancers that were either relapsed or refractory after at least 1 standard therapeutic 
regimen for their tumor type (N = 495 patients in the safety population, 402 patients received 
10 mg/kg sacituzumab govitecan). Patients were enrolled regardless of TROP-2 expression 
and treated with sacituzumab govitecan monotherapy. Doses of 8 to 18 mg/kg were tested, 
with the 10 mg/kg dose selected for further investigation. Of over 15 histologies tested, 
4 histologies were selected for further expansion because of the clinical activity noted. 
These histologies include TNBC, NSCLC, SCLC, and urothelial cancer (UC).
•
Study IMMU-132-05, a Phase 3 study of sacituzumab govitecan compared with single-agent 
chemotherapy in patients with unresectable locally advanced or mTNBC who had received at 
least 2 prior therapies (N = 582 patients in the safety population including 258 patients with 
sacituzumab govitecan and 224 patients with single-agent chemotherapy); included a 
pharmacokinetic (PK)-electrocardiogram (ECG) substudy of 29 patients from the 
sacituzumab govitecan treated group to assess the effects of sacituzumab govitecan on 
cardiac repolarization (QTc interval) and other ECG parameters.
•
Study IMMU-132-06, an ongoing Phase 2 study in patients with locally advanced or mUC 
(N = 135) that included: 1) a cohort of patients who progressed after prior platinum-based 
and PD-1/PD-L1 inhibitor therapy (N = 113) and 2) a cohort of patients who were platinum 
ineligible and received PD-1/PD-L1 inhibitor therapy in the first-line metastatic setting 
(N = 22).
1.1.3.1.
Pharmacokinetics and Immunogenicity
The serum PK of sacituzumab govitecan and free SN-38 were evaluated in a Phase 1/2 study in a 
population of subjects with mTNBC who received sacituzumab govitecan as a single agent at a 
dose of 10 mg/kg. The mean PK parameters of sacituzumab govitecan and free SN-38 as 
determined by non-compartmental analysis are presented in Table 1.

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Table 1. 
Summary of Mean Pharmacokinetic Parameters(± Standard 
Deviation) of Sacituzumab Govitecan and Free SN-38 
Sacituzumab Govitecan 
Free SN-38 
-----
Abbreviations: AUCo-!68 = area under the plasma concentration-time ctu-ve from time zero (0) through 168 hours; 
Cmax = maximum plasma concentration. 
-
-
Metabolism 
No metabolism studies with sacituzumab govitecan have been conducted. SN-38 (the small 
molecule moiety of sacituzumab govitecan) is metabolized via human 
UDP-glucuronosylti-ansferase lAl (UGTIAJ). The glucuronide metabolite of SN-38 (SN-38G) 
was detectable in the sernm of subjects. 
Excretion 
As repo1ted, SN-38 and SN-38G appear to be mainly eliminated via bilia1y excretion. 
Immunogenicity 
As with all therapeutic proteins, there is a potential for an immune response to sacituzumab 
govitecan. Based on available data in the Overall Safety Population (n 
the rate of 
u-eatment-emergent and persistent anti-mug antibodies (ADAs) is ve1y low and has been limited 
to 3 subjects (0.7%), with an additional 17 subjects (4%) having a h'ansient ADA-positive 
sample. None of the u-eatment-emergent and confnmed positive subjects experienced infusion 
reactions or adverse events (AEs) suggestive of immunogenicity. 
1.1.3.2. 
NSCLC 
Summaiy of Clinical Efficacy 
Sacituzumab govitecan has been evaluated in patients with metastatic NSCLC in a clinical study: 
Study IMMU-132-01 (based on a database cutoff date of 01 March 2019 - completed; 
54 patients enrolled). The NSCLC population in this study was heavily pretreated with a median 
of 3 prior therapies (range: 2 to 7 prior therapies) {Heist 2017}. 
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In Study IMMU-132-01, objective response rate (ORR) based on local response assessment was 
16.7% for the NSCLC population; all responses were partial responses (PRs). The majority of 
patients had at least a 30% reduction in the size of the target lesion.
Median duration of response (DOR) by local assessment was 6.0 months (range: 2.5 to 
21.0 months). The Kaplan-Meier estimate of the percentage of patients with a response of 
6 months was 44.4% (95% CI: 13.6, 71.9).
Endometrial Cancer
Sacituzumab govitecan has been evaluated in patients with metastatic endometrial cancer in a 
clinical study: Study IMMU-132-01 (based on a database cutoff date of 
01 March 2019 – completed; 18 patients enrolled).
In Study IMMU-132-01, ORR based on local response assessment was 22.2% for the 
endometrial population; all responses were PRs. The majority of patients had at least a 30% 
reduction in the size of the target lesion.
Median DOR had not been reached as of the data cutoff.
SCLC
Sacituzumab govitecan has been evaluated in patients with metastatic SCLC in a clinical study: 
Study IMMU-132-01 (based on a database cutoff date of 01 March 2019 – completed; 
62 patients enrolled). The SCLC population in this study was heavily pretreated with a median of 
2 prior therapies including patients who were chemosensitive or chemoresistant to first-line 
chemotherapy and also in patients who failed second-line topotecan therapy {Gray 2017}.
In Study IMMU-132-01, ORR based on local response assessment was 17.7% for the SCLC 
population; all responses were PRs. The majority of patients had at least a 30% reduction in the 
size of the target lesion.
Median DOR by local assessment was 5.7 months (range: 3.6 to 19.9 months). The 
Kaplan-Meier estimate of the percentage of patients with a response of 6 months was 45.5% 
(95% CI: 16.7, 70.7).
Additional information regarding the efficacy data can be found in the current edition of the 
Investigator’s Brochure.
1.1.3.3.
Summary of Sacituzumab Govitecan Safety Data
The safety profile of sacituzumab govitecan has been characterized based on 795 patients who 
received a starting dose of 10 mg/kg of sacituzumab govitecan in Studies IMMU-132-01 
(N = 402, regardless of tumor type; data cutoff date 01 March 2019), IMMU-132-05 (N = 258; 
data cutoff date 11 March 2020), and IMMU-132-06 (N = 135; data cutoff date 
18 September 2020). As of the data cutoff dates for these studies, the median treatment duration 
was 4.1 months (6 cycles). The following is a summary of the safety profile; additional details 
can be found in the current edition of the Investigator’s Brochure.

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Nearly all subjects experienced at least 1 AE; approximately 77% of subjects experienced at least 
1 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 
≥ Grade 3 AE; 37% experienced at least 1 serious adverse event (SAE). The protocol provided 
instructions for dose reduction and dose interruption, and treatment discontinuation based on 
toxicities. AEs led to treatment interruption in 55% of subjects; however, only 8% of subjects 
discontinued because of AEs. Fatal AEs (within 30 days of the last dose) occurred in 2% of 
subjects; 2 were assessed as treatment-related (sepsis in the setting of febrile neutropenia in a 
subject with UC; aspiration pneumonia in the setting of disease progression in a subject with 
NSCLC who had persistent nausea and vomiting after each infusion of sacituzumab govitecan).
The most common AEs (all grade, NCI-CTCAE Grade 3-4 frequencies) were nausea (66.3%, 
4.2%), diarrhea (64.8%, 10.6%), neutropenia (58.4%, 43.8%), fatigue (54.5%, 7.4%), alopecia 
(44.7%, 0), anemia (41.5%, 13.0%), vomiting (38.7%, 2.5%), and constipation (37.2%, 0.6%). 
The most clinically relevant Grade 3 or Grade 4 AEs with sacituzumab govitecan were 
neutropenia and diarrhea. Febrile neutropenia occurred in 6.5% of subjects. The most frequent 
AEs that led to treatment interruption (occurring in ≥ 2% of subjects) were neutropenia (34%), 
anemia (5%), leukopenia (5%), diarrhea (4%), fatigue (3%), nausea (2%), vomiting (2%), febrile 
neutropenia (2%), and upper respiratory tract infection (2%). The most frequent AEs leading to 
dose reduction (occurring in ≥ 2% of subjects) were neutropenia (5%), diarrhea (3%), and fatigue 
(2%). The most frequent AEs leading to permanent discontinuation of sacituzumab govitecan 
(occurring in ≥ 0.5% of subjects) were fatigue (0.8%), diarrhea (0.6%), pneumonia (0.6%), and 
neutropenia (0.5%).
Neutropenia typically occurred in the first cycle of treatment and resolved within approximately 
1 week of onset. Most cases of neutropenia were not febrile, were nonserious, and could be 
managed with granulocyte-colony stimulating factor (G-CSF) administration and/or dose 
reduction after Cycle 1. Fatal infections in the setting of neutropenia have been observed in 
clinical trials with sacituzumab govitecan (SG), primarily in the first 2 cycles of treatment.
Diarrhea with sacituzumab govitecan typically occurred within the first treatment cycle (median 
time of 12 days to first event) and resolved within approximately 1 week of onset. Most of the 
cases of diarrhea were nonsevere, nonserious, and did not lead to either a treatment interruption 
or dose reduction.
Hypersensitivity and infusion-related reactions have been observed. One subject in Study 
IMMU-132-01 experienced a grade 3 serious adverse event of anaphylactic reaction during 
Cycle 4 Day 1 that resolved with antihistamine, corticosteroids, and epinephrine treatment; 
sacituzumab govitecan was permanently discontinued.
As noted in Section 1.1.3.1, SN-38 (the active metabolite of irinotecan) is metabolized by 
UGT1A1. Irinotecan-treated subjects who are homozygous for the UGT1A1 *28 allele are at 
increased risk for neutropenia and diarrhea {CAMPTOSAR 2020}. Pooled data from Studies 
IMMU-132-01, IMMU-132-05, and IMMU-132-06 who received 10 mg/kg of sacituzumab 
govitecan indicate higher incidences of neutropenia, febrile neutropenia, and anemia in patients 
who were homozygous for the UGT1A1*28 allele compared with patients who were 
heterozygous for the UGT1A1*28 allele and patients who were homozygous for the wild-type 
allele.

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1.1.4.
Rationale for Dose Regimen
The proposed sacituzumab govitecan dosing regimen for this study (10 mg/kg on Day 1 and 8 of 
a continuous 21-day cycle) is the same as the labeled dosage currently approved in TNBC. 
Selection of this regimen was based on the dose-optimization performed in the Phase 1 part of 
Study IMMU-132-01, where dose escalation was performed according to a standard 3 + 3 
design, and based on planned initial dose levels of 8, 12, and 18 mg/kg. A sacituzumab govitecan 
dose of 12 mg/kg was formally identified as the maximum tolerated dose (MTD), but it was 
associated with dose delays and reductions in several subjects. To determine a maximum 
acceptable dose, additional subjects were treated at the 8 mg/kg dose level, and an intermediate 
dose cohort of 10 mg/kg was added to the study. Both dose levels were shown to be better 
tolerated in the first cycle than the previously determined MTD of 12 mg/kg, allowing for 
repeated cycles with a better safety profile. Interim analyses demonstrated that subjects receiving 
the 10 mg/kg dose achieved a treatment duration that was comparable with subjects receiving the 
8 mg/kg dose. However, compared with the 8 mg/kg dose level, there was no worsening of AE 
incidence or severity with the 10 mg/kg dose. The 10 mg/kg dose achieved a better ORR, clinical 
benefit rate (CBR), and progression-free survival (PFS) than the 8 mg/kg dose in subjects with 
TNBC, specifically {Ocean 2017}. Based on these results, 10 mg/kg was chosen as the dose for 
further study. Additional information regarding the safety and efficacy of sacituzumab govitecan 
can be found in the current edition of the Investigator’s Brochure and TRODELVY™ labeling 
information.
1.2.
Study Rationale
TROP-2, the trophoblastic cell-surface antigen-2, is a transmembrane calcium signal transducer 
glycoprotein of the TACSTD (tumor-associated calcium signal transducer) gene family, 
expressed in many normal tissues, including the epithelial barrier/lining of the stratum basale 
epidermis, breast, cervix, cornea, the epithelial secretory tissue of the endocrine and exocrine 
glands, esophagus, lung, pancreas, salivary gland, tonsils, trachea, urothelium, and uterus, in 
addition to several other tissues {Shvartsur 2015, Trerotola 2010}. In contrast to normal tissues, 
TROP-2 is overexpressed in many epithelial cancers {Alberti 2007} and has been implicated as 
an oncogene. It is thought to be a poor prognostic factor and is found in more aggressive tumors 
{Cubas 2009, Cubas 2010, Fang 2009, Fong 2008a, Fong 2008b, Guerra 2008, Kobayashi 2010, 
Köbel 2008, Ohmachi 2006, Stepan 2011, Wu 2013}. TROP-2 may confer the capability for 
proliferation and invasion to cancer cells, regulating cell growth, transformation, regeneration, 
and proliferation. Evidence of TROP-2 expression has been noted on several tumors including 
NSCLC, head and neck squamous cell carcinoma (HNSCC), SCLC, endometrial carcinoma, UC, 
and TNBC.
As described in Section 1.1.3, sacituzumab govitecan has been investigated in several clinical 
studies and has demonstrated clinical activity in a TROP-2 unselected population. While data 
indicate significant activity in a TROP-2 unselected population of TNBC {Bardia 2017, Bardia 
2021} and UC {Bardia 2021} subjects, encouraging clinical activity was demonstrated in 
multiple types of cancers {Bardia 2021} including NSCLC {Heist 2017}, SCLC {Gray 2017}, 
HNSCC, and endometrial cancer in TROP-2 unselected subjects enrolled in Study 
IMMU-132-01. Limited data are available in HNSCC.

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Despite recent approvals of novel agents like programmed death-ligand 1 (PD-L1) or 
programmed cell death protein 1 (PD-1) inhibitors in NSCLC, HNSCC, endometrial carcinoma, 
and SCLC, for subjects with advanced disease who have exhausted multiagent chemotherapy 
and PD-L1 or PD-1 therapy, the therapeutic options are often single agent chemotherapy which 
provided limited benefit.
A) NSCLC
The current treatment paradigm for patients with advanced NSCLC is the combination of 
platinum-based therapy with immune checkpoint inhibitors. Patients who do not receive this 
treatment in combination are treated with this agent sequentially. Upon progression with immune 
checkpoint inhibitors and platinum-based chemotherapy, a very few treatment options exist with 
the most common treatment being docetaxel. Other options include docetaxel + ramucirumab, 
pemetrexed (if not already given) and other single agent chemotherapy. These treatments provide 
poor outcomes with minimal benefit and overall survival (OS) less than 1 year {Hanna 2004, 
Horn 2017, Mazieres 2021, Shepherd 2000} and hence they represent a patient population of 
high unmet medical need.
TROP-2 is highly expressed in NSCLC and sacituzumab govitecan has shown encouraging 
single agent clinical activity in a heavily pretreated NSCLC patient population in Study 
IMMU-132-01. In this study, the aim is to obtain clinical data on additional NSCLC patients in 
the current clinical landscape.
B) HNSCC
Platinum agents have been the mainstay for initial treatment in patients with metastatic and 
recurrent HNSCC. Recently the addition of immune checkpoint inhibitors has revolutionized the 
treatment for patients whose tumors express PD-L1. These immune checkpoint inhibitors are 
used either alone (combined positive score [CPS] ≥ 20%) or in combination with platinum-based 
chemotherapy (CPS < 20%). However, most patients progress after these treatments. Limited 
treatment options exist after patients have exhausted platinum-based chemotherapy and immune 
checkpoint inhibitors. Current options include single agent chemotherapy such as methotrexate 
or docetaxel, or cetuximab. Efficacy results from studies using these treatments show ORR in 
range of 5.8 to 10.6%, median PFS around 2.3 months, and OS ranging from 5.1 to 6.9 months 
{Cohen 2019, Ferris 2018}. Therefore, a high unmet need exists for improved treatments in this 
setting. TROP-2 is highly expressed in HNSCC and therefore, sacituzumab govitecan provides 
an opportunity for improved clinical outcomes in this setting.
C) Endometrial carcinoma
The initial treatment for patients with advanced endometrial carcinoma is largely standardized by 
platinum chemotherapy. Upon progression on platinum agents, the subsequent treatment has 
been pembrolizumab monotherapy in a small subgroup of patients with microsatellite 
instability-high (MSI-H)/mismatch repair deficient (dMMR)/high tumor mutational burden-high 
(TMB-H). Very recently pembrolizumab in combination with lenvatinib received full approval in 
this patient population regardless of the MSI-H/dMMR status {Merck 2021}. For patients whose 

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cancer(s) has failed the aforementioned ti·eatments, single agent chemotherapy (ie, docetaxel, 
doxornbicin, or paclitaxel) remains the main stay of ti·eatment and that has ve1y poor outcomes. 
Hence, these patients represent a population of high unmet medical need. 
Sacituzumab govitecan has demonsti·ated activity in endometi·ial carcinoma in TROP-2 
unselected subjects enrolled in Study IMMU-132-01. In this study, the aim is to obtain clinical 
data on additional endometi·ial carcinoma patients in the cmTent clinical landscape. 
D) SCLC 
Single agent chemotherapy with topotecan is a common cunent standard of care ti·eatment in 
patients with extensive stage SCLC whose tumors have progressed on platinum and 
PD-(L)l combination and has been evaluated in several randomized clinical studies. Efficacy 
results from studies using these ti·eatments show ORR in the range of 16.5 to 25%, median PFS 
from 2.7 to 3.8 months, and OS ranging from 7.4 to 8.4 months {Baize 2020, Spigel 2021} 
More recently lurbinectedin has been evaluated in the post-platinum and immuno-oncology (IO) 
setting as well. Results from initial u-ial were encouraging showing ORR of 35%. However, 
subsequent confnmato1y study failed to show benefit over cmTent standard of care. In the 
Phase 3 ATLANTIS ti·ial, comparing the combination of lurbinectedin and doxornbicin versus 
chemotherapy (topotecan or cyclophosphamide, doxornbicin, and vincristine), the lurbinectedin 
aim had an ORR of 31.6% with PFS of 4 months and median OS of 8.6 months and the 
chemotherapy aim had an ORR of 29.7% with median PFS of 4 months and median OS of 
7.6 months {Paz-Ares 2021}. 
Given the lack of durable response and with the median survival is 
1 yeai·, there is a significant 
unmet medical need for additional therapeutic options in SCLC cohort Sacituzumab govitecan is 
an ADC that uses an SN-38 payload which has been proven to be an effective agent in SCLC. 
It has achieved encouraging activity in Study IMMU-132-01 and therefore, it waiTants fmt her 
evaluation in SCLC. 
This study will enroll subjects with NSCLC (adenocai·cinoma and squamous cell carcinoma 
[SCC]), HNSCC, endometi·ial cai·cinoma, and SCLC. This study will provide fmther clinical data 
to suppo1t the clinical activity of sacituzumab govitecan in the cunent landsca e and to fmther 
ex lore the relationshi between clinical data and TROP-2 ex ression levels 
1.2.1. 
Potential Benefits 
Sacituzumab govitecan has demonsti·ated encouraging activity in multiple cancer types as 
described in the eai·lier Section 1.1.3.2. Sacituzumab govitecan seems well-tolerated and induced 
durable responses in heavily preti·eated patients; therefore, the potential therapeutic benefit for 
the patient populations tai·geted in this study seems substantial and wo1t h evaluating fmther in 
additional patients. 
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1.2.2.
Benefit-Risk Assessment
Sacituzumab govitecan has a significant risk of causing fatigue, diarrhea, nausea, and cytopenia 
with an overall treatment discontinuation rate of 8%. Further, there is a potential increase in risk 
of toxicities in subjects bearing UGT1A1*1/*28 and *28/*28 genotypes as reported with the 
SN-38 metabolite of irinotecan. However, the rates of toxicity are manageable with dose 
modifications and the judicious use of dose delays. Neutropenia may be further managed with 
the addition of growth factor support. Fatal infections in the setting of neutropenia have been 
observed in clinical trials with SG, primarily in the first 2 cycles of treatment, hence primary 
prophylaxis with G-CSF is recommended starting in the first cycle in patients at increased risk of 
febrile neutropenia eg, older patients (in particular aged 65 years and older), patients with 
previous neutropenia, poor performance status, organ dysfunction (including renal, liver or 
cardiovascular dysfunction), or multiple comorbid conditions. Absolute neutrophil count must be 
monitored during treatment. Despite the risk of these toxicities, the potential therapeutic benefit 
for the patient populations targeted in this study is substantial. In patients with limited treatment 
options with little benefit, in terms of approved therapies, and a limited expectation of survival, 
sacituzumab govitecan may offer a survival benefit by targeting a protein highly expressed on 
these specific tumor types. The favorable benefit-risk profile of this product warrants further 
investigation given the high unmet medical need in the targeted patient populations.
An unanticipated event such as a disaster or public health emergency may pose additional risks 
to study drug availability, the study visit schedule, and adherence to protocol-specified safety 
monitoring or laboratory assessments. For details on the risk and mitigation strategy refer to 
Appendix 17.7.

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2 _ 
STUDY OBJECTIVES AND ENDPOINTS 
Primary Objective 
Primary Endpoint 
Assess the ORR of sacituzumab govitecan in subjects 
with metastatic solid tumors by Investigator's 
assessment according to the Response Evaluation 
Criteria in Solid Tumors Version 1.1 (RECIST 1.1) 
criteria. 
Objective response rate (ORR) according to RECIST 
1.1 by Investigator's assessment. 
Secondary Objectives 
• 
Assess the ORR, DOR, CBR, and PFS of 
• 
sacituzumab govitecan in subjects with metastatic 
solid tumors by blinded independent central review 
• 
(BICR) according to RECIST 1.1 criteria. 
• 
• 
• 
Assess the DOR, CBR, and PFS of sacituzumab 
govitecan in subjects with metastatic solid tumors 
by Investigator's assessment according to RECIST 
1 . 1 criteria. 
Assess the OS of sacituzumab govitecan in 
subjects with metastatic solid tumors. 
Assess the safety of sacituzumab govitecan in 
subjects with metastatic solid tumors. 
• 
Assess the PK and immunogenicity of sacituzumab 
govitecan in subjects with metastatic solid tumors. 
• 
• 
• 
I 
I 
I 
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Secondary Endpoints 
ORR, DOR, CBR, and PFS according to RECIST 
1.1 byBICR. 
DOR, CBR, and PFS according to RECIST 1.1 by 
Investigator's assessment. 
Overall survival (OS) . 
Incidence of treatment-emergent AEs and clinical 
laborato1y abnormalities. 
Sernm concentrations of sacituzumab govitecan 
over time and incidence of anti-dtug antibody 
(ADA) to sacituzumab govitecan. 
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3.
INVESTIGATIONAL PLAN
This is a multi-cohort, open-label, Phase 2 study designed to assess the efficacy and safety of 
sacituzumab govitecan in adult subjects with metastatic solid tumors. Upon meeting the 
eligibility criteria, the subjects are treated with sacituzumab govitecan at 10 mg/kg via 
intravenous infusion on Days 1 and 8 of a 21-day cycle. The original protocol included the 
following cohorts: NSCLC (adenocarcinoma and SCC), HNSCC, and endometrial carcinoma.
With Amendment 3, this study is a single stage cohort evaluation for proof of concept (POC) 
with recalculation of sample sizes for all the cohorts. An additional cohort for SCLC has been 
added. OS is included as a secondary objective and endpoint and will be assessed for all cohorts. 
The correlation of clinical activity to TROP-2 expression is included as an exploratory endpoint 
(see study schema in Figure 1).
Figure 1.
Study IMMU-132-11 Schema
ADA = anti-drug antibody; BICR = blinded independent central review; CBR = clinical benefit rate; D = day; DOR = duration of 
response; IO = immuno-oncology; IV = intravenous; m = metastatic; mHNSCC = metastatic head and neck squamous cell 
carcinoma; mNSCLC = metastatic non-small cell lung cancer; mSCLC = metastatic small cell lung cancer; ORR = objective 
response rate; OS = overall survival; PA5 = Protocol Amendment 5; POC = proof of concept; PD = progressive disease; PFS = 
progression-free survival; PK = pharmacokinetic; RECIST v1.1 = Response Evaluation Criteria in Solid Tumors Version 1.1; 
SCC = squamous cell carcinoma; s/p = status post
a.
Exact sample size calculations for each of the cohorts for POC stage are outlined in Section 11.1.
b.
Expansion stage planned only for HNSCC, endometrial, and SCLC cohorts (if efficacy signal met in the POC stage).
Following implementation of PA5, subjects who previously discontinued treatment will no longer be followed for survival 
follow-up and subsequent therapy and will discontinue the study as per sponsor’s decision.
mN!SCLC; 
Treatment 
(Adenocarcinoma and 
until PD or 
sec cohorts) -
unacceptable 
sip 10 and platirium-based 
toxicity 
regimen 
l 
Efficac~ 
m HNSCC: 
Sacituzumab 
Continue 
Survival 
sip 10 and platinum-based 
: lialbilit\ 
Govltecan 
enrollment to 
follow-
regimen 
met 
10 mg/kg IV (D1 and 
slgnalmv 
total NI -100-
DB every 21 days) 
120/cohortb 
up 
mEndometrlal 
N -30-40/cohorta 
carcinoma: 
Signal seeking for POC 
Expansion stage 
s/p 10 and platinum-based 
regimen 
Primary endpoint: ORR (by Investigator-assessed REC I ST v1 .'1) 
Seconda!)l endpoints: 
mSCLC: 
-
ORR, DOR, CBR, PFS (by BICR RECIST v1.1) 
sip 10 arid platinum-based 
-
DOR, CBR, PFS (by Investigator-assessed REC I ST v1 .1) 
,--
-
regimeri 
OS 
-
-
Safety assessment 
-
PK & ADA assessment 

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Approximately, a total of 165 subjects will be enrolled for the initial POC stage, that is, 
30 subjects for each of the NSCLC (adenocarcinoma and SCC) and HNSCC cohorts, 35 subjects 
for the endometrial carcinoma cohort, and 40 subjects for the SCLC cohort. Once the efficacy 
bars are reached in any of the endometrial carcinoma, HNSCC, or SCLC cohorts, the Sponsor 
may choose to expand the specific cohort(s) and continue to enroll additional subjects, so that 
approximately a total of 100 to 120 subjects (including subjects enrolled in the initial stage) in 
each selected cohort will be accrued. If one or more cohorts are expanded, the total study sample 
size combining subjects in both the POC and the expansion stage can be up to approximately 
225 to 
 subjects.
Subjects will be treated until PD (according to RECIST 1.1 by Investigator’s assessment), 
unacceptable toxicity, study withdrawal, or death, whichever comes first. However, treatment 
may be continued beyond PD if there is evidence of clinical benefit per the Investigator and the 
subject is tolerating study treatment. The clinical criteria for subjects to continue to receive 
treatment beyond the Investigator-assessed progression are defined in Section 4.3.1.
Subjects will then be followed every 12 weeks for survival, unless the subject explicitly indicates 
a desire to forego survival follow-up to their study Investigator. Subjects will be followed until 
death, withdrawal of consent, lost to follow-up, Sponsor-terminated study or completion of 
survival follow-up (24 months after the last subject is dosed), whichever occurs first.
The end of study for a subject occurs when there is a death event, withdrawal of consent, or loss 
to follow-up is documented. The end of the entire study for all subjects is defined as the date on 
which the last subject remaining on study completes the last study visit/call/survival follow-up or 
when the Sponsor decides to end the study. The Sponsor reserves the right to terminate the study 
at any time for any reason (including safety). At the completion of the study, subjects who are 
deriving benefit from sacituzumab govitecan may continue to receive treatment in a rollover 
study (Study IMMU-132-14) in locations where the study is available.
Study modifications after implementation of Protocol Amendment 5 (PA5):
Following implementation of PA5, subjects who are still receiving treatment may continue 
treatment as part of the study for as long as they are deriving clinical benefit. Radiographic 
tumor assessments per protocol will be discontinued; however, treatment response should 
continue to be evaluated per standard of care. Information on study drug administration and 
safety assessments will continue to be collected. Subjects who have discontinued treatment and 
were being followed for survival and subsequent therapy at the time of PA5 implementation, will 
be discontinued from the study and survival follow-up with subsequent therapy information will 
no longer be collected.
CCI

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All subjects must be dosed within 28 days of providing written info1med consent. Unless 
othe1wise specified, visit windows are within - 1 and +2 days for the treatment schedule and 
± 7 days for response assessments. Absolutely no waivers for subject eligibility will be 
pe1mitted. 
Samples for PK, ADA, and biomarker analyses will be collected according to the protocol 
schedule of assessments and are to be shipped to the Sponsor's designee. Othe1wise, all other 
laborato1y procedures are to be perfo1med locally at each study site (Table 2). 
The schedule of assessments for all subjects before implementation of PAS is presented in 
Table 2. The schedule of assessments for all subjects who continue treatment following 
implementation of PAS is presented in Table 3. 
4.1. 
Informed Consent 
No study-specific procedure or alteration of subject care will be undertaken until info1med 
consent has been obtained from the subject or their legally authorized representative. However, 
procedures such as laborato1y work or imaging that were perfo1med per standard of care may be 
utilized for Screening if they were perfo1med within the proposed screening window with the 
subject's consent. The Investigator will explain the nature and scope of the study, potential risks 
and benefits of participation, and answer all questions for the subject or their legally authorized 
representative. Subjects must be info1med of available alternative treatment options prior to 
consenting to pa1ticipate in this study. 
If the subject agrees to paiticipate, the infonned consent fo1m must be signed, dated, and 
witnessed, with a copy given to the subject. The consenting process must be well documented by 
each investigational site. 
4.2. 
Screening Evaluations 
Screening evaluations conducted to establish eligibility will be peifonned within 28 days prior to 
Cycle 1, Day 1 (ClDl ) (Table 2): 
• 
Signed infonned consent (prior to any screening evaluations). 
• 
Tumor blocks (preferably obtained within 12 months of study entiy if clinically feasible) or 
20 newly sectioned unstained slides (6 slides minimum) of ai·chived biopsy/surgical 
specimens are requested. A baseline biopsy is required if archival tissue is not available. 
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Fine needle aspirates and bone biopsies are not suitable samples. These specimens should be 
submitted within the 28-day screening period, after the subject provides written info1med 
consent. 
• 
• 
Eligibility (inclusion/exclusion criteria). 
• 
Medical/surgical histo1y review with treatment histo1y to include treatment response and 
time to progressive disease (PD) from the last therapy regimen. 
• 
Complete physical examination including, height, weight, and Eastern Cooperative Oncology 
Group (ECOG). 
• 
12-lead electrocardiogram (ECG). 
• 
Vital signs defined as heali rate, blood pressure, respirato1y rate, and body temperature, taken 
after the subject has been resting for at least 5 minutes. 
• 
Sernm beta-human chorionic gonadotropin (~-hCG), in women of childbearing potential 
during screening, and urine pregnancy test at baseline (prior to study treatment 
administration on ClDl). The urine pregnancy test at baseline does not need to be conducted 
if the sennn pregnancy test at screening was perfo1med within 72 hours before study 
treatment administration on C 1 D 1. 
• 
Sernm follicle-stimulating ho1mone (FSH) testing will be conducted as needed per 
Appendix 17.5 for dete1mination of childbearing potential. 
• 
Complete blood count (CBC) with differential. If the baseline sample was collected 
> 72 hours prior to ClDl, then it must be repeated to confom eligibility prior to dosing. 
• 
HIV antibody test. 
• 
Hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) test. Subjects 
who test positive for the anti-HBc test will require hepatitis B vims (HBV) DNA by 
quantitative polymerase chain reaction (PCR). 
• 
Hepatitis C (HCV) antibody test. Subjects with a known histo1y ofHCV or a positive HCV 
antibody test will not require an HCV antibody at Screening and will only require HCV 
ribonucleic acid (RNA) by quantitative PCR for confomation of active disease. 
• 
Routine sernm cheinistries including liver function tests, glucose, creatinine, blood urea 
nitrogen (BUN), total bilirnbin, aspaiiate aininotransferase (AST), alanine aminotransferase 
(ALT), alkaline phosphatase, sennn albumin, total protein, sodium, potassium, calcium, 
chloride, bicai·bonate, magnesium, and phosphorns, lactate dehydrogenase (LDH), and uric 
acid. If routine chemistries and liver function tests were collected > 72 hours prior to ClDl , 
then it must be repeated to confmn eligibility prior to dosing. 
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•
Urinalysis only for Screening.
•
Brain MRI in subjects with known central nervous system (CNS) disease or with suspicion of 
CNS disease. Target and non-target lesions must be determined by the study site at baseline.
•
Computed tomography (CT) or magnetic resonance imaging (MRI) scan with intravenous 
(IV) contrast as appropriate (chest, abdomen, pelvis, and other regions of known/suspected 
involvement) unless there is a known anaphylaxis to contrast and/or medically 
contraindicated as described in Section 9.
•
Record AEs.
•
Prior/concomitant medications review.
•
All subjects who previously failed screening may be rescreened only once (Section 6.1).
4.3.
Procedures During Treatment
Note: CBC with differential, serum chemistries, and liver function tests, as well as pregnancy 
tests in women of childbearing potential need not be repeated for C1D1 if they were obtained for 
Screening within 72 hours prior to dosing.
•
Sacituzumab govitecan dosing is based on the subject’s body weight at enrollment (C1D1). 
The dose is to remain constant throughout the study unless there is a > 10% change in body 
weight from enrollment (C1D1) (Table 2).
•
Vital signs including blood pressure, heart rate, pulse, respiratory rate, and body temperature 
on C1D1 prior to infusion. Additional collection of vital signs will be needed in the event of 
suspected infusion-related reaction.
•
Blood samples prior to infusion for:
CBC with differential on Days 1 and 8 of each cycle. CBC does not need to be repeated 
at C1D1 if the screening sample was collected within the previous 72 hours. If the 
baseline sample was collected > 72 hours prior to C1D1, then it must be repeated to 
confirm eligibility prior to dosing. Hematology tests may be performed and reviewed up 
to 24 hours prior to scheduled study treatment administration.
Serum chemistry panel including liver function tests, glucose, creatinine, BUN, total 
bilirubin, AST, ALT, alkaline phosphatase, serum albumin, total protein, sodium, 
potassium, calcium, chloride, bicarbonate, magnesium, and phosphorus. Serum 
chemistries are required for all subjects on Days 1 and 8 of every subsequent cycle 
(repeated assessment at C1D1 is not required if the screening sample was collected 
within the previous 72 hours). These laboratory assessments may be performed more 
frequently at the discretion of the treating physician if abnormal results warrant 
follow-up. Serum chemistries may be performed and reviewed up to 24 hours prior to 
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• 
Blood for PK sennn samples will be collected from all subjects at pre-sacituzumab govitecan 
infusion and at End of Infusion (EOI) on Day 1 of Cycles 1, 2, 3, 7, 11, and eve1y 6 cycles 
thereafter (17, 23, etc), EOT with sacituzumab govitecan, and at the 30-Day Safety 
Follow-up Visit. There will be an additional collection pre-dose on C1D8. The collection 
window for PK samples is -30 minutes for predose (prior to the sta1t of infusion), 
+ 10 minutes for postdose samples (at EOI), and ±10 minutes for all other timepoints. PK 
sernm samples for subjects continuing sacituzumab govitecan treatment following 
implementation of P A5 will not be collected. 
• 
Blood for immunogenicity samples (ADA) will be collected from all subjects at 
pre-sacituzumab govitecan infusion on Day 1 of Cycles 1, 2, 3, 7, 11, and eve1y 6 cycles 
thereafter (17, 23, etc), EOT with sacituzumab govitecan, and at the 30-Day Safety 
Follow-up Visit. All ADA samples will be collected predose with a collection window of 
-30 minutes prior to the sta1t of infusion. ADA samples for subjects continuing sacituzumab 
govitecan treatment following implementation of P A5 will not be collected. 
• 
Blood for biomarker samples will be collected from all subjects receiving sacituzumab 
govitecan before infusion on Day 1 of Cycles 1, 3, 5, 7, 9, 11, and eve1y 3 cycles thereafter 
(Cycles 14, 17, etc) and at EOT. Biomarker samples for subjects continuing sacituzumab 
govitecan treatment following implementation of P A5 will not be collected . 
• 
• 
Blood sample collection for UGTlAl genotyping. This sample should be collected at the 
ClDl visit. If the sample is not collected at ClDl, then it can be collected at any other visit. 
UGTlAl genotyping blood samples for subjects continuing treatment following 
implementation of P A5 will not be collected. 
• 
A 12-lead ECG will be obtained prior to the ClDl infusion. Abno1mal findings should be 
evaluated as clinically indicated, including repeated ECGs. ECGs may be done at other 
timepoints during the study if clinically indicated. 
• 
Urinalysis will be perfonned only if clinically indicated with abnonnal results captured on 
the electronic case repo1t fo1m ( eCRF). 
• 
Clinically targeted physical examination including weight. 
• 
Record AEs (at eve1y visit). 
• 
Record conc01nitant medications; continued, changed (at eve1y visit). 
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•
CT or MRI scan with IV contrast (chest, abdomen, and pelvis with scanning of other regions 
including brain MRI as clinically indicated) examinations, unless known anaphylaxis to 
contrast and/or medically contraindicated as described in Section 9. Subjects who continue 
treatment following implementation of PA5 will be expected to have scans performed per 
standard of care, as indicated by local practice. Tumor response data will no longer be 
collected for this study; however, disease status should still be monitored by the treating 
physician to determine if progression has occurred, and whether the subject is continuing to 
derive clinical benefit.
•
•
Pregnancy testing at monthly intervals.
4.3.1.
Treatment After Progression
Subjects will be treated until PD (according to RECIST 1.1 by Investigator’s assessment), 
unacceptable toxicity, study withdrawal, or death, whichever comes first. However, treatment 
may be continued beyond PD if there is evidence of clinical benefit per the Investigator and the 
subject is tolerating study treatment. The following clinical criteria should be met for subjects to 
continue to receive treatment beyond the Investigator-assessed progression:
•
Absence of symptoms and signs indicating clinically significant progression of disease.
•
No decline in performance status.
•
Absence of symptomatic rapid disease progression requiring urgent medical intervention (eg, 
symptomatic pleural effusion, spinal cord compression).
Sponsor consultation is required before subjects initiate the treatment beyond progression. If this 
occurs, the subject will remain in the study and continue to be monitored according to the 
protocol schedule of assessments (Table 2).
4.4.
End of Treatment Visit
The End of Treatment (EOT) Visit should be conducted within 30 days after the decision has 
been made to discontinue treatment. If this is scheduled for 30 days (± 14 days) after the last 
dose, the results from these assessments may also be used for the 30-Day Safety Follow-up Visit. 
Subjects who discontinue treatment because of toxicity will continue with radiologic response 
assessments at the protocol-required schedule, until PD or initiation of new therapy with capture 
of radiologic evidence of PD if clinically feasible. The reason for treatment discontinuation will 
be documented and any treatment-related AEs or clinically significant abnormal laboratory 
values at that time will be followed until resolution or stabilization.
•
Complete physical examination including weight.
•
Blood samples for:
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CBC with differential.
Serum chemistry panel and liver function tests, glucose, creatinine, BUN, total bilirubin, 
AST, ALT, alkaline phosphatase, serum albumin, sodium, potassium, calcium, chloride, 
bicarbonate, magnesium, and phosphorus.
•
Urine pregnancy test.
•
Tumor assessment: CT or MRI scan with IV contrast as appropriate (chest, abdomen, pelvis, 
and other regions of known/suspected involvement), unless known anaphylaxis to contrast or 
medically contraindicated as described in Section 9. If imaging was obtained within 2 weeks 
of the EOT Visit, imaging does not need to be repeated.
•
Blood collection for PK and ADA serum samples.
•
Blood collection for biomarker samples.
•
Record AEs.
•
Concomitant medications.
•
For subjects continuing treatment following implementation of PA5, EOT assessments will be 
performed according to Table 3.
4.5.
30-Day Safety Follow-Up Visit
A single Safety Follow-up Visit will occur 30 days (± 3 days) after the last dose of study drug 
and will include:
•
Complete physical examination including weight.
•
Urine pregnancy test.
•
Blood samples for:
CBC with differential.
Serum chemistry panel and liver function tests, glucose, creatinine, BUN, total bilirubin, 
AST, ALT, alkaline phosphatase, serum albumin, sodium, potassium, calcium, chloride, 
bicarbonate, magnesium, and phosphorus.
•
Blood collection for PK and ADA serum samples.
•
Concomitant medications.
•
Record AEs.
•
Collection of subsequent anti-cancer treatment.
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If the EOT Visit occurs at the same time or within 14 days of the scheduled 30-Day Safety 
Follow-up Visit, the same assessments may be utilized for both visits.
For subjects continuing treatment following implementation of PA5, the 30-Day Safety 
Follow-up Visit assessments will be performed according to Table 3.
4.6.
Treatment Discontinuation
Subjects may discontinue the study drug under any of the following conditions:
1) Withdrawal of consent from further treatment with study drug.
2) Lost to follow-up (see Section 4.6.1).
3) An AE that, in the opinion of the Investigator or the Sponsor, contraindicates further dosing.
4) Initiation of alternative anti-tumor therapy, including any other investigational product.
5) Pregnancy.
6) More than a 3-week dose delay from the planned treatment date due to treatment-related 
toxicity or 5-week dose delay for all other reasons.
7) PD without evidence of clinical benefit with continued therapy.
8) Subject non-compliance.
9) Suspension of the study by the Sponsor.
10) Death.
11) Investigator’s or treating physician decision in the absence of any of the above.
Study drug discontinuation should not result in subject discontinuation from the study, and the 
subject should continue to be followed up in the study for disease progression and survival per 
Section 4.7. Reasons for discontinuation from the study are described in Section 4.8.
If a subject discontinues study treatment (eg, as a result of an AE), every attempt should be made 
to keep the subject in the study and continue to perform the required study-related follow-up 
procedures (see Section 4.7). If this is not possible or acceptable to the subject or Investigator, 
the subject may be withdrawn from the study.

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4.6.1.
Lost to Follow-up
A subject will be considered lost to follow-up if the subject 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 subject fails to return to the clinic for a required study 
visit:
•
The site must attempt to contact the subject and reschedule the missed visit as soon as 
possible, counsel the subject on the importance of maintaining the assigned visit schedule 
and ascertain whether the subject wishes to and/or should continue in the study.
•
Before the subject is deemed lost to follow-up, the Investigator or designee must make every 
effort to regain contact with the subject (where possible, 2 telephone calls, and if necessary, a 
certified letter to the subject’s last known mailing address or local equivalent methods). 
These contact attempts should be documented in the subject’s source documents.
•
Should the subject continue to be unreachable, the subject will be considered lost to 
follow-up.
For subjects who are lost to follow-up, study staff may use public records (eg, public health 
records) to obtain information about survival status where allowable by local regulation.
4.7.
Safety/End of Treatment and Survival Follow-up
After discontinuation of treatment (see Section 4.6), all subjects must complete an EOT Visit 
30 days after the last dose of study drug and a 30-Day Safety Follow-up Visit (Table 2). Subjects 
will then be followed every 12 weeks for survival, unless the subject explicitly indicates a desire 
to forego survival follow-up to their study Investigator. Subjects will be followed until death, 
withdrawal of consent, lost to follow-up, Sponsor-terminated study or completion of survival 
follow-up (24 months after the last subject is dosed), whichever occurs first. This follow-up 
assessment may be conducted by telephone or in-clinic visit and will include documentation of 
any subsequent therapy for their cancer.
For subjects who are lost to follow-up, study staff may use public records (eg, public health 
records) to obtain information about survival status where allowable by local regulation.
Following implementation of PA5, subjects who previously discontinued treatment will no 
longer be followed for survival follow-up and subsequent therapy and will discontinue the study 
as per sponsor’s decision.
4.8.
End of Study
The end of the study for a subject’s participation occurs when they have completed all periods of 
the study including long-term or survival follow-up due to the following reasons: death, the 
subject withdraws consent, there is documented loss to follow-up of the subject, or the Sponsor 
terminated the study, whichever comes first.

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Please note, the End-of-Study page is also expected to be entered into the Electronic Data 
Collection (EDC) system once a subject completes the study even if there was no death event, 
withdrawal of consent, or loss to follow-up. The End-of-Study page is required to be completed 
in addition to the End-of-Treatment page. 
Following implementation of P A5: 
• 
Subjects may continue ti·eatment as paii of the study, for as long as they are deriving clinical 
benefit. After they meet one of the criteria for ti·eatment discontinuation (Section 4.6), they 
will have an EOT visit and a 30-Day Safety Follow-up Visit. There will be no additional 
assessments including survival follow-up and subsequent therapy collection. 
• 
Subjects will have the end of study at the same time as the EOT visit (Section 4.4). However, 
if at the time of an EOT visit, subjects have unresolved AEs, the end of study for that subject 
may be delayed until all AEs have been resolved or stabilized per Section 10.2.2.1. 
The end of the entire study for all subjects is defined as the date on which the last subject 
remaining on study completes the last study visit/call/survival follow-up or when the Sponsor 
decides to end the study. The Sponsor reserves the right to terminate the study at any time for 
any reason (including safety). 
At the completion of the study, subjects who ai·e deriving benefit from sacituzumab govitecan 
monotherapy may continue to receive u-eatment in a rollover study (Study IMMU-132-14) in 
locations where the study is available. This rollover study is designed to provide continued 
access to sacituzumab govitecan for eligible subjects who have previously paiiicipated in a 
Gilead-sponsored pai·ent study, who ai·e tolerating sacituzumab govitecan, have no evidence of 
PD, or are still deriving clinical benefit despite progression (as assessed by the Investigator). 
Subjects may receive the dose of sacituzumab govitecan cmTently receiving in the pai·ent study at 
the time of consenting to pa1iicipate in the rollover study, if applicable. 
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5.
STUDY EVALUATIONS
All subjects must be dosed within 28 days of providing written informed consent. No subject 
may be dosed until the Sponsor or their representative has approved the eligibility packet. Clear 
documentation as to the reason the subject was not dosed should be provided on the relevant 
eCRF. Unless otherwise specified, visit windows are permitted either 1 day before or + 2 days 
after scheduled visits and ± 7 days for response assessments. Treatment delays for reasons other 
than required for resolution of treatment-related toxicity are not permitted.

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Table 3.
Modified Schedule of Assessments/Study Calendar (After Implementation of PA5)
Visit
Treatment
Cycle
ALL Cycles
Daya
1
8
EOT Visitb
30-Day Safety 
Follow-up Visitc
Weightd
X
X
X
Physical examinatione
Per standard of care
X
X
Vital signsf
As needed
Study drug administration
X
X
Urine Pregnancy test (if applicable)g
X
X
X
Serum Follicle-Stimulating Hormone (FSH)h
As needed
Hematologyi
X
X
X
X
Serum chemistry including liver function testsj
X
X
X
X
Tumor assessment (CT or MRI scan)k
Per standard of care
AE reportingl
X
X
X
X
Prior/concomitant medications
X
X
X
X
Subsequent anti-cancer treatment
X
Abbreviations: AE = adverse event; ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; BUN = blood urea nitrogen ; CBC = 
complete blood count; CT = computed tomography; eCRF = electronic case report form; EOT = end of treatment; MRI = magnetic resonance imaging; PA5 = Protocol 
Amendment 5; SAE = serious adverse event.
a
Unless otherwise specified, visit windows are within −1 to +2 days of the schedule visits and ±7 days for response assessments.
b
The EOT Visit should occur within 30 days of the decision to discontinue treatment. If the EOT Visit and 30-Day Safety Follow-up Visit occur within 14 days of each other, 
the same assessment results may be utilized for both study visits.
c
The Safety Follow-up Visit should be conducted 30 days (± 3 days) after the last dose of study drug.
d
During treatment, subject’s body weight will be measured on Day 1 of each treatment cycle (or more frequently if the subject’s body weight changed by >10% since the 
previous administration), at the EOT Visit, and at the 30-Day Safety Follow-up Visit.
e
Complete physical examinations will be performed at the EOT Visit and the 30-Day Safety Follow-up Visit. At study visits during the Treatment Phase, physical 
examinations should be performed per institutional practice.
f
Collection of vital signs will be needed in the event of suspected infusion-related reaction. Vital signs will include blood pressure, heart rate, pulse, respiratory rate, and body 
temperature and will be taken after the subject has been resting for at least 5 minutes.

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g
In females of childbearing potential, pregnancy testing will be performed on Day 1 of each treatment cycle, and every 28 days after the last dose of study drug up to 6 months 
after the last dose of study drug per the duration of required contraception, as described in Appendix 17.5. Testing during the posttreatment period may be performed at home 
and the result is to be self-reported by the subject. If the urine test is positive or equivocal, a confirmatory serum pregnancy test will be required.
h
Conduct as needed per Appendix 17.5.
i
CBC with differential for all subjects is required at Days 1 and 8 of each cycle, and the EOT Visit and 30-Day Safety Follow-up Visit. Hematology tests may be performed 
and reviewed up to 24 hours prior to scheduled study treatment administration. See Section 7.5.2.5 for when sacituzumab govitecan should be administered based on ANC.
j
Serum chemistries include liver function test, glucose, creatinine, BUN, total bilirubin, AST, ALT, alkaline phosphatase, serum albumin, total protein, sodium, potassium, 
calcium, chloride, bicarbonate, magnesium, and phosphorus. Serum chemistries are required in all subjects at Days 1 and 8 of every cycle, the EOT Visit, and 30-Day Safety 
Follow-up Visit. These laboratory assessments may be obtained more frequently at the discretion of the treating physician if abnormal results warrant follow-up. Serum 
chemistries may be performed and reviewed up to 24 hours prior to scheduled study treatment administration. 
k
Subjects who continue treatment following implementation of PA5 will be expected to have scans performed per standard of care, as indicated by local practice. Tumor 
response data will no longer be collected for this study; however, disease status should still be monitored by the treating physician to determine if progression has occurred, 
and whether the subject is continuing to derive clinical benefit.
l
All AEs and SAEs must be reported in eCRF and to Gilead Global Patient Safety from first dose of study drug until 30 days after last dose of study drug or initiation of 
alternative therapy for underlying disease in accordance with instructions in Section 10.2.5. SAEs that occur after initiation of a new anticancer therapy will not be reported.

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5.1.
Medical History and Demographic/Baseline Characteristics
Basic demographic and baseline characteristics will be collected during Screening. In addition to 
the evaluation of a subject’s medical history to determine study eligibility, all relevant medical 
conditions will be documented on the appropriate eCRF. Events that occur after signing of 
informed consent but prior to initiation of study drug(s), unless it was due to a 
protocol-mandated procedure, should be recorded on the Medical History eCRF.
The subject’s entire oncology history for the tumor of interest will be collected on the 
appropriate eCRF including cancer histology, stage, and date of diagnosis, prior 
surgeries/treatments received for cancer, dates of treatment administration, intent of administered 
regimen (neoadjuvant, adjuvant, or metastatic), best response achieved, and date of PD.
5.2.
Prior and Concomitant Medication Assessments
Medications administered prior to the first dose of study drug will be recorded as prior 
medications, whereas medications initiated after administration of the first dose of study drug 
until 30 days after treatment discontinuation will be captured as concomitant medications. 
Medication information will be entered in the appropriate eCRF with information regarding 
dose, indication, route of administration, and dates of administration. Medications used for 
prophylaxis of anticipated study drug AEs as outlined in the protocol should be documented 
along with the rationale for prophylactic intent.
5.3.
Other Study Evaluations
For other study evaluation parameters, please refer to the following sections:
•
Efficacy evaluation (Section 9).
•
Safety evaluations (Section 10.1 and Section 10.2).
•
PK evaluations (Section 10.3).
•
Immunogenicity (ADA) evaluations (Section 10.4).
•
Biomarker evaluations (Section 10.6).

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6.
TARGET POPULATION
Adult subjects with histologically documented advanced or metastatic NSCLC (adenocarcinoma 
or SCC), HNSCC, endometrial carcinoma, or SCLC histology. All subjects must meet the 
eligibility criteria as described in Section 6.2 and Section 6.3.
6.1.
Screen Failures
Subjects who consent to participate in the clinical study, and who do not meet at least 1 criterion 
required for participation in the study during the screening procedures are considered screen 
failures. All subjects who have signed informed consent and were deemed ineligible will be 
recorded in a log with the reason for ineligibility. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants, to meet the Consolidated 
Standards of Reporting Trials (CONSORT) publishing requirements, and to respond to queries 
from regulatory authorities. Minimal information includes demography, informed consent date, 
screen failure details, eligibility criteria, screen failure date, and any AEs and SAEs.
All subjects who previously failed screening may be rescreened only once.
All screening tests must be obtained during the 28-day screening period after the subject 
provides written informed consent and prior to C1D1. Subjects who are rescreened are 
considered previous screen failures and they will be enrolled in the study and assigned a new 
subject number at the time of rescreening.
6.2.
Subject Inclusion Criteria
Subjects meeting all the following inclusion criteria at Screening will be eligible for participation 
in the study.
1) Female or male adults, > 18 years of age, who are able to understand and give written 
informed consent.
2) Subjects with the following histologically documented metastatic (M1, Stage IV) or locally 
advanced solid tumors.
a) NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based 
chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy given 
sequentially (in either order) or in combination. These agents could have been taken as 
monotherapy or in combination with other agents. If subjects have had recurrence/relapse 
or lack of response within 6 months of completing chemotherapy with or without 
PD-(L)1 directed therapy for locally advanced disease, that line of therapy may be 
counted for eligibility.
b) HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 
directed therapy given sequentially (in either order) or in combination. These agents 
could have been taken as monotherapy or in combination with other agents. No more 
than 3 prior lines of systemic treatment is allowed.

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c) Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and 
anti-PD-(L)1 directed therapy given sequentially (in either order) or in combination. 
These agents could have been taken as monotherapy or in combination with other agents. 
No more than 3 prior lines of systemic treatment is allowed. Endometrial carcinoma with 
any histology including MSI-h/dMMR and MSS are allowed.
d) Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and 
PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed 
(re-challenge with the same initial regimen is not allowed).
3) ECOG Performance Status score of 0 or 1 (see Appendix 17.2).
4) Adequate hematologic counts without transfusional or growth factor support within 2 weeks 
of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count 
(ANC) ≥ 1,500/mm3, and platelets ≥ 100,000/µL).
5) Adequate hepatic function [bilirubin ≤ 1.5 institutional upper limit of normal (IULN), AST 
and ALT ≤ 2.5 × IULN or ≤ 5 × IULN if known liver metastases and serum albumin 
≥ 3 g/dL].
6) Creatinine clearance ≥ 30 mL/min as assessed by Cockcroft-Gault (see Appendix 17.3).
7) Subjects must have at least a 3-month life expectancy.
8) Have measurable disease by CT or MRI scan as per RECIST 1.1 criteria (see 
Appendix 17.4). Tumor lesions situated in a previously irradiated area may be utilized if they 
are considered measurable and PD has been demonstrated in such lesions.
9) Male subjects and female subjects of childbearing potential who engage in heterosexual 
intercourse must agree to use protocol-specified method(s) of contraception as described in 
Appendix 17.5.
10) Tumor blocks (preferably obtained within 12 months of study entry if clinically feasible) or 
20 newly sectioned unstained slides (6 slides minimum) of archived biopsy/surgical 
specimens are requested. A baseline biopsy is required if archival tissue is not available. 
Fine needle aspirates and bone biopsies are not suitable samples. These specimens should be 
submitted within the 28-day screening period, after the subject provides written informed 
consent.

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6.3.
Subject Exclusion Criteria
Subjects meeting any of the following exclusion criteria at Screening will not be enrolled in the 
study.
1) Positive serum pregnancy test (Appendix 17.5) or women who are lactating.
Article I.
Are currently participating in or have participated in a study of an investigational 
agent or using an investigational device within 4 weeks prior to the first dose of 
study drug. Subjects participating in observational studies are eligible.
Article II.
Have had a prior anti-cancer biologic agent within the 4 weeks prior to Day 1 or 
have had prior chemotherapy, targeted small molecule therapy, or radiation therapy 
within 2 weeks prior to study Day 1.
Article III. Have not recovered (ie, ≤ Grade 1) from AEs caused by a previously administered 
agent.
•
Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are exceptions to this 
criterion and may qualify for the study.
•
Note: If subjects underwent major surgery, they must have recovered adequately from the 
toxicity and/or complications from the intervention prior to starting study drug.
•
Note: Subjects with Grade ≤ 2 immune-mediated toxicities (except colitis) related to 
immunotherapy and/or radiation treatment that are long lasting, but stable on treatment 
and not requiring agents that are excluded by this protocol may qualify for the study.
2) Have previously received topoisomerase I inhibitors (for SCLC cohort: Etoposide with 
platinum combination in first-line setting is allowed).
3) Have an active second malignancy.
•
Note: Subjects with a history of malignancy that has been completely treated, with no 
evidence of active cancer for 3 years prior to enrollment, or subjects with surgically cured 
tumors with a low risk of recurrence may be enrolled.
4) Have known active CNS metastases and/or carcinomatous meningitis. Subjects with 
previously treated brain metastases may participate provided they have stable CNS disease 
for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have 
returned to baseline, have no evidence of new or enlarging brain metastases, and are taking 
≤ 20 mg/day of prednisone or its equivalent. All subjects with carcinomatous meningitis are 
excluded regardless of clinical stability.

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5) Have active cardiac disease, defined as:
•
Myocardial infarction or unstable angina pectoris within 6 months of Day 1.
•
History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular 
fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring 
anti-arrhythmic medications (except for atrial fibrillation that is well controlled with 
anti-arrhythmic medication); history of QT interval prolongation.
•
New York Heart Association (NYHA) Class III or greater congestive heart failure or left 
ventricular ejection fraction of < 40%.
6) Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease), 
immune-mediated colitis, or GI perforation within 6 months of C1D1.
7) Have an active infection requiring IV antibiotics.
8) Have positive HIV-1 or HIV-2 antibody with detectable viral load or taking medications that 
may interfere with SN-38 metabolism (the active metabolite of sacituzumab govitecan).
9) Have active HBV or HCV, subjects with a detectable viral load will be excluded.
•
Subjects who test positive for HbsAg. Subjects who test positive for anti-HBc will 
require HBV DNA by quantitative PCR for confirmation of active disease.
•
Subjects who test positive for HCV antibody. Subjects who test positive for HCV 
antibody will require HCV RNA by quantitative PCR for confirmation of active disease. 
Subjects with a known history of HCV or a positive HCV antibody test will not require 
an HCV antibody at screening and will only require HCV RNA by quantitative PCR for 
confirmation of active disease.
10) Have other concurrent medical or psychiatric conditions that, in the Investigator’s opinion, 
may be likely to confound study interpretation or prevent completion of study procedures and 
follow-up examinations.
11) Impending need for palliative radiation therapy or surgery for pathological fractures and/or 
for medullary compression within 4 weeks prior to initiating study treatment.
12)  Additional cohort-specific exclusion criteria:
NSCLC cohort (adenocarcinoma and SCC):
a) Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses 
including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli 
within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary 
disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective 
tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, 
Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.

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HNSCC cohort:
a) Subjects with nasopharynx carcinoma.
b) Subjects who had progressive disease within 6 months of completion of curative therapy.
Endometrial carcinoma cohort:
a) Subjects who have carcinosarcoma (malignant mixed Mullerian tumor), endometrial 
leiomyosarcoma, and/or endometrial stromal sarcomas.
Small cell lung cancer cohort:
a) Subjects who never received platinum-containing regimen for SCLC.
b) Limited-stage subjects who are candidates for local or regional therapy.

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7.
TREATMENT OF SUBJECTS
7.1.
Description of Study Drug
Sacituzumab govitecan is an ADC composed of hRS7, a humanized immunoglobulin G (IgG)1κ 
monoclonal antibody, which binds to TROP-2 (trophoblast cell-surface antigen-2), SN-38, a 
camptothecin analog which is an inhibitor of topoisomerase I, and CL2A, a linker that couples 
SN-38 to hRS7.
7.2.
Concomitant Medications
No anti-cancer therapies, aside from the study drug (sacituzumab govitecan) are permitted during 
this study. However, palliative and/or supportive medications, such as pain medications, 
bone-modifying medications (bisphosphonates or denosumab), anti-emetics or anti-diarrheal 
medications, transfusions, and growth factor support are allowed at the Investigator’s discretion. 
Palliative radiotherapy of non-target lesions is permitted, but presence of new or worsening 
metastases will be considered PD. Palliative radiation of target lesions should be avoided and 
will make the subject unevaluable per protocol. However, if there is clear evidence of clinical 
benefit, treatment may be continued after completion of palliative radiotherapy to lesions that are 
not target lesions. In this case, sacituzumab govitecan administration should be interrupted 
1 week before the procedure and reinstated no earlier than 2 weeks after the procedure. If a 
subject requires surgery, administration of sacituzumab govitecan should be interrupted 1 week 
before the procedure if clinically feasible and dosing should be held for 2 weeks after the 
procedure. Dosing may resume thereafter if the subject is clinically stable. Extensive surgical 
procedures, such as abdominal, or cranial surgeries, may require suspension of dosing for 
4 weeks to allow for an adequate period for healing before the subject may resume treatment. 
The medical monitor for the study must approve continuation of therapy with sacituzumab 
govitecan prior to resumption of dosing.
There is not substantial safety data regarding the concurrent administration of the COVID‑19 
vaccine and sacituzumab govitecan. Subjects are allowed to receive the COVID‑19 vaccine to 
reduce the risk and complications of COVID‑19 infection. The study visits should continue as 
planned if vaccination occurs while the subject is on the study. For details on the risk and 
mitigation strategy for concurrent administration of the COVID-19 vaccine, refer to 
Appendix 17.7.
7.3.
Treatment Compliance
Sacituzumab govitecan will be administered at scheduled study sites under the supervision of the 
Investigator or sub-Investigator(s). The pharmacist will maintain records of study drug receipt, 
preparation, and dispensing, including the applicable lot numbers, subject’s height and weight, 
and total study drug administered in milligrams. Any discrepancy between the calculated dose 
and dose administered and the reason for the discrepancy must be recorded in the source 
documents.

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Randomization and Blinding 
Not applicable. 
7.5. 
Treatment of Sacituzumab Govitecan-Associated Toxicities 
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Instiuctions for the preparation and administration of the infusion of sacituzumab govitecan are 
provided in Section 8.4 and Section 8.5, respectively. The following sections provide guidance 
for sacituzumab govitecan administi·ation and management of ti·eatment-related toxicities, 
including modification of dosing and ti·eatment discontinuation. Toxicities should be assessed 
and managed in accordance with standard clinical and institutional practices and accepted 
ti·eatment guidelines. 
7.5.1. 
Preventative Medications 
Guidance for premedication for prevention of toxicities associated with sacituzumab govitecan is 
presented in Table 4. 
-
-
I 
I 
I 
I 
I 
ANC = absolute neutrophil count; ASCO = American Society of Clinical Oncology; ESMO = European Society for Medical 
Oncology; G-CSF = granulocyte-colony stimulating factor; IV = intravenous; NCCN = National Comprehensive Cancer 
Institute; PO = orally; SG = sacituzumab govitecan 
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All patients should be given medications to take home with clear instructions for the prevention 
and treatment of nausea, vomiting, and diarrhea. At the onset of diarrhea, promptly initiate 
treatment with anti-diarrheals (eg, loperamide at 4 mg initially followed by an additional 2 mg 
with every episode of diarrhea for a maximum of 16 mg daily or follow local label guidelines for 
loperamide). Discontinue anti-diarrheals 12 hours after diarrhea resolves. Additional supportive 
measures (eg, fluid and electrolyte substitution) may also be employed as clinically indicated. 
Subjects who exhibit an excessive cholinergic response to treatment with sacituzumab govitecan 
(eg, abdominal cramping, diarrhea, salivation) can receive appropriate premedication 
(eg, anti-cholinergics such as atropine) for subsequent infusions.
Additional details of recommended treatment of infusion-related reactions are described in 
Section 7.5.2.1 The recommended treatment of delayed nausea and vomiting is described in 
Section 7.5.2.2.
7.5.2.
Management of Sacituzumab Govitecan Toxicities
NCI-CTCAE v5.0 is used to grade the severity of all AEs. The guidelines for management of 
toxicities associated with sacituzumab govitecan are based on the assessment of severity 
according to these criteria. Toxicities should be managed in accordance with standard medical 
practice and treatment guidelines. All clinically appropriate imaging or laboratory testing should 
be utilized to fully assess a toxicity to determine the appropriate treatment. Appropriate 
follow-up studies should be utilized to follow all toxicities to resolution. Subjects with known 
UGT1A1 *28 polymorphisms may have a higher risk of developing treatment-related toxicities. 
Additional monitoring may be required in those subjects. Subjects suspected of having 
underlying UGT1A1 *28 polymorphisms because of increased episodes of diarrhea or 
neutropenia, should have their polymorphism assessed. If found to have the *1/*28 or 
*28/*28 polymorphism, this data should be recorded in the eCRF with dosing adjusted per 
institutional standards. Instructions for sacituzumab govitecan dose reduction for 
treatment-related toxicities are provided in Section 7.5.2.5.
7.5.2.1.
Infusion-Related Reactions
Infusion-related reactions are defined as symptoms that occur during and within the first 6 hours 
after the infusion of sacituzumab govitecan. Symptoms can include fever, chills, rigors, 
arthralgias, myalgias, urticaria, pruritus, rash, diaphoresis, hypotension, dizziness, syncope, 
hypertension, dyspnea, cough, and wheezing, as well as severe hypersensitivity reactions 
including anaphylactic reactions. Infusion-related reactions should be treated in accordance with 
best clinical practices and standard institutional guidelines. Because of the potential for 
life-threatening infusion-related reactions, sacituzumab govitecan should only be administered in 
a setting in which appropriately trained medical staff, emergency equipment, and medications are 
available if resuscitation is required. NCI-CTCAE v5.0 is used to grade the severity of all 
infusion-related AEs. Premedication for the prevention of infusion-related reactions is described 
in Section 7.5.1.

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Grade 4 Events
Grade 4 reactions include potentially life-threatening reactions, requiring urgent intervention. If 
Grade 4 infusion-related reactions occur, sacituzumab govitecan should be permanently 
discontinued (Table 6).
Grade 2 and Grade 3 Events
Grade 2 infusion-related reactions are defined as those that require infusion interruption and 
respond to symptomatic treatment; prophylactic medications are indicated for ≤ 24 hours. For 
Grade 2 infusion-related reactions, the infusion should be interrupted until symptoms resolve. 
After symptoms resolve, the infusion should be resumed at a slower infusion rate determined by 
the managing physician. Grade 3 infusion-related reactions are defined as those which are 
prolonged and do not improve with symptomatic treatment and/or brief interruption of treatment, 
reactions that recur following treatment, and reactions that require hospitalization. For recurrent 
Grade 2 and Grade 3 infusion-related reactions despite optimal management, sacituzumab 
govitecan should be permanently discontinued (Table 6).
7.5.2.2.
Gastrointestinal Toxicities
Nausea, vomiting, and diarrhea are toxicities that are frequently associated with sacituzumab 
govitecan. Appropriate treatment, including fluid and electrolyte replacement, is required to 
minimize the risk of serious consequences such as dehydration. Instructions for sacituzumab 
govitecan dose reduction for treatment-related GI toxicities are provided in Section 7.5.2.5.
Nausea and Vomiting
Instructions for the use of pre-medications for prophylactic treatment of nausea and vomiting and 
anticipatory nausea are provided in Section 7.5.1. Withhold sacituzumab govitecan for Grade 3 
nausea or Grade 3 or 4 vomiting at the time of scheduled treatment administration and resume 
with additional supportive measures when resolved to Grade ≤ 1. Subjects may be treated for 
delayed nausea and vomiting on Days 2 and 3 with 5-HT3 receptor antagonist (ondansetron or 
palonosetron) monotherapy and other agents if needed. Steroids may be added if symptoms do 
not resolve with these agents. Consider olanzapine for persistent or anticipatory nausea; an 
olanzapine dose of 2.5 mg or 5 mg at bedtime is recommended. Neurokinin 1 (NK1) receptor 
antagonists (fosaprepitant and aprepitant) may be administered.
Diarrhea
Dietary modification should be recommended for the management of diarrhea, including 
adequate fluid intake to maintain hydration. Loperamide can be administered at the onset of 
treatment-related Grade 1 or Grade 2 diarrhea, at an initial dose of 4 mg, followed by 2 mg with 
every episode of diarrhea to a maximum dose of 16 mg/day. If diarrhea is not resolved after 
24 hours, the Investigator (or treating physician) should consider adding diphenoxylate/atropine 
and/or opium tincture, as clinically indicated.

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Consider adding octreotide 100 to 150 µg subcutaneous (SC) 3 times per day (TID) if diaIThea 
persists. Withhold sacituzumab govitecan for Grade 3 or Grade 4 diaIThea at the time of 
scheduled treatment administration and resume when resolved to Grade :'.S 1. For Grade 3 or 
Grade 4 diaiThea, the subject may be hospitalized, and treated with IV fluids and octi·eotide. 
Antibiotics can be administered as clinically indicated. 
Subjects who exhibit an excessive cholinergic response to treatment with sacituzumab govitecan 
( eg, abdominal cramping, diaiThea, salivation) can receive appropriate premedication 
( eg, ati·opine) for subsequent ti·eatment with sacituzumab govitecan. 
7.5.2.3. 
N euti·openia 
Info1mation regai·ding the prophylaxis and management of neuti·openia and febrile neutropenia 
with G-CSF are included in Table 4. Fever, fatigue, lethai·gy, malaise, loss of appetite, and 
decreased production of mine ai·e potential early symptoms of febrile neuti·openia. In subjects 
who develop neuti·openia or febrile neuti·openia, treat with G-CSF and consider prophylaxis in 
subsequent cycles as clinically indicated. Initiation of anti-infective treatment in subjects with 
febrile neuti·openia without delay is strongly recommended. SG dosing should be intenupted and 
modified in accordance with Table 6. 
7.5.2.4. 
Overdose 
Overdose is defined as administi·ation of more than 10% higher dose than the calculated dose. In 
the event of an overdose, closely monitor the subject per standard institutional guidelines. Any 
AE resulting from overdose should be repo1ied as described in Section 10.2.2. 
7.5.2.5. 
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Sacituzumab Govitecan Dose Delays, Dose Reductions, and Discontinuation 
Guidelines 
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Event
NCI-CTCAE v5.0
Occurrence
Recommended dose 
reduction or action
Any Grade 3 or Grade 4 nausea, vomiting or diarrhea due to 
treatment that is not controlled with anti-emetics and 
anti-diarrheal agents
OR
Other Grade 3 or Grade 4 non-hematologic toxicity persisting 
> 48 hours despite optimal medical management
OR
At time of scheduled treatment, Grade 3 or Grade 4 non-
neutropenic hematologic or non-hematologic toxicity, that delays 
dosing by 2 or 3 weeks for recovery to ≤ Grade 1
Third
Discontinue treatment
In the event of Grade 3 or Grade 4 non-neutropenic hematologic 
or non-hematologic toxicity that does not recover to ≤ Grade 1 
within 3 weeks
First
Discontinue treatment
Infusion-Related Toxicities
Grade 2 or Grade 3 infusion-related reactions despite optimal 
management
Recurrent
Discontinue treatment
Grade 4 infusion-related reaction
First
Discontinue treatment
Abbreviations: G-CSF = granulocyte-colony stimulating factor; NCI-CTCAE = National Cancer Institute-Common Terminology 
Criteria for Adverse Events.
7.6.
Drug Interactions
No formal drug-drug interaction studies with sacituzumab govitecan have been conducted. 
SN-38 (the active metabolite of sacituzumab govitecan) is metabolized via human UGT1A1. 
Concomitant administration of inhibitors or inducers of UGT1A1 (Appendix 17.6), with 
sacituzumab govitecan, should be avoided because of the potential to either increase (inhibitors) 
or decrease (inducers) the exposure to SN-38, unless there are no therapeutic alternatives.
7.6.1.
UGT1A1 Inhibitors
Co-administration of sacituzumab govitecan with inhibitors of UGT1A1 may increase systemic 
exposure to the active metabolite, SN-38. Do not administer UGT1A1 inhibitors with 
sacituzumab govitecan unless there are no therapeutic alternatives. A list of example UGT1A1 
inhibitors is provided in Appendix 17.6.
7.6.2.
UGT1A1 Inducers
Exposure to SN-38 may be substantially reduced in subjects concomitantly receiving UGT1A1 
enzyme inducers. Do not administer UGT1A1 inducers with sacituzumab govitecan unless there 
are no therapeutic alternatives. A list of example UGT1A1 inducers is provided in 
Appendix 17.6.

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8.
STUDY DRUG MATERIALS AND MANAGEMENT
8.1.
Study Drug
Sacituzumab govitecan is supplied as a sterile, off-white to yellowish lyophilized powder in 
single-dose glass vials. It is formulated in 2-(N-morpholino) ethane sulfonic acid buffer 
containing trehalose and polysorbate 80 and contains no preservatives. Following reconstitution, 
the concentration of sacituzumab govitecan is 10 mg/mL. The pH of the reconstituted solution is 
approximately 6.5.
8.2.
Study Drug Packaging and Labeling
Sacituzumab govitecan is packaged in single-use, 50R, glass vials, closed with coated 
elastomeric stoppers and capped with flip-off caps with aluminum over seals. Study drug to be 
distributed to centers in the US and other participating countries shall be labeled to meet 
applicable requirements of the US Food and Drug Administration (FDA), European Union (EU) 
Guideline to Good Manufacturing Practice–Annex 13 (Investigational Medicinal Products), 
and/or other local regulations.
8.3.
Study Drug Storage
The glass vials of sacituzumab govitecan must be stored under refrigeration (2-8 °C) and 
protected from light until use. Since the formulated drug product contains no preservative, vials 
should be used only once. Refer to the current version of the Pharmacy Manual for additional 
details.
8.4.
Study Drug Preparation
Calculate the prescribed dose in mg based on the subject’s body weight at enrollment (C1D1) 
(unless there is a > 10% change in body weight from enrollment or if required by institutional 
policy). Calculate the number of vials required for a dose, based on maximum concentration of 
10 mg/mL after reconstitution.
The Pharmacist is required to follow the appropriate steps regarding the reconstitution and 
dilution of the drug product per the Pharmacy Manual.
8.5.
Administration
Do not administer as an IV push or bolus. Sacituzumab govitecan is administered via IV infusion 
as described below with additional information available in the current version of the Pharmacy 
Manual.
•
Administer the first infusion over 3 hours (±15 minutes). Subsequent infusions may be 
administered over 1 to 2 hours if previous infusions were well tolerated. Monitor the subject 
during the infusion, and for at least 30 minutes after infusion.

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9.
ASSESSMENT OF EFFICACY
CT or MRI scans with IV contrast of the chest, abdomen, pelvis, and any other involved disease 
sites (including brain MRI if appropriate) are to be obtained in all subjects (unless known 
anaphylaxis to contrast and/or medically contraindicated). If the use of IV contrast is medically 
contraindicated for a subject, 1 of the following options may be used (listed in order of 
preference): CT without contrast, MRI without contrast, or attempt to desensitize the subject 
with steroids. For each subject, the same imaging technique should be used throughout the study 
for tumor assessment. If a subject had brain lesions at study entry, brain MRI will be needed at 
all assessments. The timing of imaging is based on calendar time from the date of C1D1. Scans 
will be performed for all subjects at baseline and every 6 weeks for the first 6 months after C1D1 
and then every 9 weeks thereafter until the occurrence of radiologic PD, as per RECIST 1.1, 
requiring discontinuation of treatment. Dose delays and cycle delays should not result in delays 
in the timing of imaging. For subjects with evidence of CR or PR, a confirmatory scan must be 
obtained at least 4 to 6 weeks after initial documentation of response CR or PR. Scans will be 
transferred to a central reader for collection and analysis by blinded independent central review 
(BICR).
Target and non-target lesions must be determined by the clinical site at baseline. Subjects who 
discontinue from treatment because of toxicity or clinical progression will continue to obtain 
radiologic response assessments at the protocol-required schedule until radiologic evidence of 
PD or initiation of new therapy, if clinically feasible. Additional CT or MRI studies may be 
performed at the discretion of the subject’s treating physician to assess disease status, as 
medically indicated. Tumor response and progression will be determined using RECIST 1.1. For 
subjects who continue treatment despite radiologic evidence of PD as defined in Section 4.3.1, 
the subject will remain in the study and continue to be monitored according to the protocol 
required schedule of assessments (Table 2). The results of all imaging including those not 
specified as protocol assessments will be recorded on the eCRF.
Subjects who continue treatment following implementation of PA5 will be expected to have 
scans performed per standard of care, as indicated by local practice. Tumor response data will no 
longer be collected for this study; however, disease status should still be monitored by the 
treating physician to determine if progression has occurred, and whether the subject is continuing 
to derive clinical benefit.

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10.
ASSESSMENT OF SAFETY
10.1.
Safety Parameters
10.1.1.
Clinical Laboratory Investigations
All clinical laboratory samples for safety will be collected and analyzed by the site’s local 
laboratory with appropriate clinical action taken based on the Investigator’s clinical judgment. 
All investigations will be assessed for all subjects at Screening, during treatment, and upon 
treatment discontinuation per the schedule of assessments (Table 2). Clinical laboratory samples 
will also be collected at the 30-Day Safety Follow-up Visit. Additional and more frequent tests 
may be performed at the Investigator’s discretion. The specific details of each assessment will be 
recorded on the appropriate eCRF. In the event of clinically significant abnormal results, tests 
should be repeated within 24 to 48 hours to confirm abnormality. Results for these laboratory 
tests should be followed until resolution. The panels of laboratory tests to be performed are 
shown below:
Hematology: hemoglobin, white blood cell (WBC) count and differential (with ANC), and 
platelet count.
Clinical Chemistry: total protein, albumin, total bilirubin, alkaline phosphatase (ALP), ALT, 
AST, creatinine (see Appendix 17.3) and clinical chemistries including glucose, sodium, 
potassium, magnesium, chloride, bicarbonate (CO2/HCO3-), calcium, phosphorus.
Urinalysis: performed locally on a freshly voided clean sample by dipstick for protein, glucose, 
blood, pH, and ketones. If dipstick findings are abnormal based on the Investigator’s judgment, 
then a microscopic evaluation will be performed to assess the abnormal findings. Urinalysis will 
be performed at Screening only and as clinically indicated with details regarding casts, WBC 
count and RBC count, and bacteria recorded. Only abnormal results will be captured on the 
eCRF.
Pregnancy and FSH Testing: Female subjects of childbearing potential must have a negative 
serum or urine pregnancy test result within 72 hours prior to administration of the first dose of 
study drug and a negative urine pregnancy test result of Day 1 of every cycle while on study 
drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will 
be required. Serum FSH testing will be conducted as needed per Appendix 17.5 for 
determination of childbearing potential.
LDH and Uric Acid: will only be required at Screening. May be obtained more frequently at the 
discretion of the treating physician if abnormal results warrant follow-up. Results of unscheduled 
tests should be documented.

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10.1.2.
Vital Signs
Vital signs will be taken at Screening, and C1D1 prior to infusion. Additional collection of vital 
signs will be needed in the event of suspected infusion-related reaction. Vital signs will include 
blood pressure, heart rate, pulse, respiratory rate, and body temperature and will be taken after 
the subject has been resting for at least 5 minutes. All vital signs will be recorded on the eCRF.
10.1.3.
Electrocardiogram
Local 12-lead ECGs will be obtained for all subjects at baseline and prior to the C1D1 infusion. 
Abnormal findings should be evaluated as clinically indicated, including repeated ECGs. ECGs 
may be done at other timepoints during the study if clinically indicated.
ECGs are to be performed at rest in the supine position. Clinically significant abnormal findings 
should be noted and the appropriate clinical work-up initiated until the condition has stabilized.
The following will be measured or calculated: heart rate, PR, QRS, QT interval, corrected 
QT interval using Fridericia’s formula (QTcF), and rhythm.
10.1.4.
Physical Examinations, Body Weight, and Height
Complete physical examinations (a minimum assessment of the following systems: head/eyes, 
ears/neck/throat, cardiac, lungs, abdomen, and extremities) will be performed during Screening, 
at the EOT Visit, and at the 30-Day Safety Follow-up Visit. Clinically targeted physical 
examinations will be performed at study visits during the Treatment Phase.
Height will be measured during the Screening Visit only. Weight will be measured per 
institutional guidelines during Screening, on Day 1 of each cycle, and at the EOT Visit and 
30-Day Safety Follow-up Visit. Only clinically significant abnormalities will be recorded on the 
appropriate eCRF.
Physical exam data for subjects following implementation of PA5 will not be collected at 
treatment visits; however, physical exams should be performed per institutional practice. Any 
abnormal findings identified should be recorded as an AE, unless already documented as part of 
medical history or if the abnormal finding is a manifestation of the disease under study.
10.1.5.
ECOG Performance Status
ECOG Performance Status will be assessed during Screening (see Appendix 17.2).
10.2.
Adverse and Serious Adverse Events
All subjects must be carefully monitored for AEs, as defined below. Sufficient information must 
be obtained by the Investigator to determine whether the event meets criteria for immediate 
reporting to the Sponsor (ie, SAEs and pregnancies). All AEs should be assessed in terms of their 
seriousness, severity, and relationship to the study drug, per the definitions in the following 
sections.

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10.2.1.
Definition of Adverse Events
10.2.1.1.
Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a subject administered 
a medicinal product that does not necessarily have a causal relationship with this treatment. An 
AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of an investigational product, 
whether or not it is related to the investigational medicinal product.
Adverse events may include worsening or exacerbation of the disease under study; worsening or 
exacerbation of pre-existing conditions or events; intercurrent illnesses; or drug interactions. 
Anticipated fluctuations of pre-existing conditions that do not represent a clinically significant 
exacerbation or worsening are not considered AEs.
Adverse events should be recorded using medical terminology and, whenever possible, a 
diagnosis should be provided for clearly associated signs, symptoms, and/or abnormal laboratory 
results. If the final diagnosis is not known at the time of initial detection, the provisional 
diagnosis or signs or symptoms should be recorded and updated when the final diagnosis is 
available.
Surgical procedures are not AEs; they are therapeutic measures for conditions that require 
surgery. The condition, provided it develops or is a worsening of a pre-existing condition for 
which the surgery is required, is the AE.
10.2.1.2.
Serious Adverse Events (SAE)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
•
Is fatal (results in death).
•
Is life-threatening: The subject was at immediate risk of death from the AE as it occurred. 
This does not include an event that, had it occurred in a more severe form or allowed to 
continue, might have caused death.
•
Requires inpatient hospitalization or prolongation of existing hospitalization (in the absence 
of a precipitating clinical AE is not in itself an SAE).
•
Results in persistent or significant disability or incapacity.
•
Is a congenital anomaly/birth defect (in the child of a subject who was exposed to the study 
drug).

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•
An important medical event that may not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, 
the event may jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition. Examples of such events are intensive 
treatments 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.
An SAE does not include:
•
PD (See Section 10.2.2.6).
•
Hospitalization for a routine clinical procedure as stipulated by the protocol.
•
Pre-planned treatments or surgical procedures requiring hospitalization (the conditions 
should be documented as appropriate in the eCRF).
•
Hospitalization for non-medical reasons (ie, social admissions, hospitalizations for social, 
convenience or respite care).
10.2.2.
Adverse Event Reporting and Assessment
10.2.2.1.
Adverse Event Reporting Period
During the period after the informed consent has been obtained and before the first dose of study 
drug, all SAEs and AEs caused by a protocol-mandated intervention (eg, biopsy) should be 
reported. All AEs and SAEs must be reported in eCRF and to Gilead Global Patient Safety from 
first dose of study drug until 30 days after last dose of study drug or initiation of alternative 
therapy for underlying disease. Subsequently, only SAEs assessed as related to study drug by the 
investigator that occur during long-term follow-up must be reported to Gilead Global Patient 
Safety in accordance with instructions in Section 10.2.5. In addition, SAEs that occur after 
initiation of a new anticancer therapy will not be reported.
•
Investigators are not obligated to actively seek SAEs after the long-term follow-up period; 
however, if the Investigator learns of any SAEs that occur after the protocol-defined 
follow-up period has concluded and the event is deemed relevant to the use of study drug, the 
Investigator should promptly document and report the event to Gilead Global Patient Safety.
10.2.2.2.
Adverse Event Collection and Documentation
Identification and Recording of Adverse Events
It is the responsibility of the Investigator to document all AEs that occur during the study. AEs 
should be elicited by asking the subject a non-leading question (eg, “Have you experienced any 
new or changed symptoms since we last asked/since your last visit?”). AEs can also represent 
abnormal findings from physical examinations, laboratory tests, and other study procedures such 
as ECGs. The Investigator must review all laboratory and test data; abnormal findings should be 
assessed to determine if they meet the criteria for AEs (Section 10.2.1.1 and Section 10.2.2.5).

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For all AEs, the Investigator must pursue and obtain information adequate to assess whether it 
meets the criteria for classification as an SAE (Section 10.2.1.2) and, therefore, requires 
immediate notification to the Sponsor or its designee (Section 10.2.5). In addition, sufficient 
information must be obtained by the Investigator to perform a causality assessment, which must 
be done for every AE. Follow-up by the Investigator is required until the event or its sequelae 
resolve or stabilize, as assessed by the Investigator. The outcome of each AE must be provided.
Adverse events should be recorded using medical terminology and whenever possible, a 
diagnosis should be provided for clearly associated signs, symptoms, and/or abnormal laboratory 
results.
To assist in the Sponsor’s assessment of each case, further information may be requested from 
the Investigator to provide clarity and understanding of the event in the context of the clinical 
study.
Serious Adverse Events
Serious adverse events (SAEs) are to be recorded on the Initial or Follow-up SAE Report Form 
and transmitted by emailing or faxing the report to the Sponsor or the Sponsor’s designee within 
24 hours of investigator’s awareness in accordance with the timelines summarized in 
Section 10.2.5. The Investigator should include a detailed description of the event(s), including 
the clinical course, criteria for seriousness, treatments administered, action taken with respect to 
study drug, rationale for the Investigator’s assessment, including causality, and any other 
relevant information, such as possible alternative etiologies.
Information captured on both the SAE Form and entered in the eCRF should be consistent.
10.2.2.3.
Assessment of Adverse Event Severity
The severity of AEs will be graded using the latest version of NCI-CTCAE v5.0. For each SAE, 
the highest severity grade should be reported. If an NCI-CTCAE criterion does not exist, the 
Investigator should assess the severity according to the criteria in Table 7.

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Table 7.
Grading for Adverse Events Not Listed in NCI-CTCAE
CTCAE Grade
Severity
Definition
Grade 1
Mild
Asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated
Grade 2
Moderate
Minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental ADL1
Grade 3
Severe
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of existing hospitalization indicated; 
disabling; limiting self-care ADL2,3
Grade 4
Life-threatening
Life-threatening consequences; urgent intervention indicated3
Grade 5
Death
Results in death
Abbreviations: ADL = activities of daily living; NCI-CTCAE = National Cancer Institute-Common Terminology Criteria for 
Adverse Events; SAE = serious adverse event.
1.
Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.
2.
Self-care ADL refer to bathing, dressing, and undressing, feeding self, using the toilet, taking medications, and not 
bedridden.
3.
These events should be assessed to determine if they meet the definition of SAEs.
10.2.2.4.
Assessment of Adverse Event Causality
The Investigator’s causality assessment is required for all AEs including both non-serious and 
serious AEs. The causality assessment is the determination of whether there exists a reasonable 
possibility that the study drug caused or contributed to an AE. To determine causality, the 
Investigator should consider the temporal relationship of the onset of the event to the start of 
study drug; the course of the event, and, more specifically whether the event resolves or 
improves with dose reduction or study drug discontinuation; the known toxicities of the study 
drug; events expected to occur in subjects with the disease under study; and concomitant 
medications and comorbidities which may have a known association with the event. Causality is 
to be assessed as follows:
•
Related: Plausible time relationship to study drug administration; plausible time relationship 
of improvement or resolution with study drug dose reduction or discontinuation; event cannot 
be explained by the underlying disease, comorbidities, or concomitant medications.
•
Possibly related: a reasonable time sequence to administration of study drug, but which 
could also be explained the underlying disease, comorbidities, or concomitant medications.
•
Unlikely related: a temporal relationship to study drug administration which makes a causal 
relationship improbable and the underlying disease, comorbidities, or concomitant 
medications provide a plausible explanation.
•
Not related: a causal relationship to the study drug can be easily ruled out.

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10.2.2.5.
Adverse Events Based on Abnormal Test Findings
An abnormal test finding that meets any 1 of the criteria below should be considered an AE:
•
Test result is associated with accompanying symptoms.
•
Test result requires additional diagnostic testing or medical/surgical intervention.
•
Test result leads to a change in study drug dosing (eg, dose modification, interruption, or 
permanent discontinuation) or concomitant drug treatment (eg, addition, interruption, or 
discontinuation) or any other change in a concomitant medication or therapy.
•
Test result leads to any of the outcomes included in the definition of an SAE (Note: This 
would be reported as an SAE, Section 10.2.5).
•
Test result is considered an AE by the Investigator.
Laboratory results that fall outside the reference range and do not meet 1 of the criteria above 
should not be reported as AEs. Repeating an abnormal test, in the absence of the above 
conditions, does not constitute as an AE. Any abnormal test result that is determined to be an 
error does not require reporting as an AE.
Any abnormal test finding that meets the criteria for an SAE (Section 10.2.1.2) should be 
reported as such.
10.2.2.6.
Disease Progression
In this protocol, PD is an efficacy endpoint and should not be reported as an AE. It is important 
to differentiate expected PD from an AE. Events that are clearly consistent with the expected 
pattern of PD should not be considered AEs. Expected PD refers to an event that is 
unequivocally related to PD, and for which the clinical course is consistent with what would be 
expected for the subject’s disease. A clinical event in the setting of PD would be considered an 
AE if it could not be unequivocally attributed to or consistent with expected PD.
Hospitalization because of signs and symptoms of PD (as defined above) should not be reported 
as SAEs.
In most cases, PD will be based on RECIST 1.1 criteria. If PD is based on the subject’s 
symptoms, every effort should be made to document progression using objective criteria.

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10.2.3.
Reporting Deaths
Death is an outcome of an SAE and not, in itself, an SAE. When death is an outcome, the 
event(s) resulting in death should be reported (eg, “pulmonary embolism” with a fatal outcome). 
The appropriate diagnosis (ie, cause of death) should be recorded and assigned severity Grade 5. 
The time period for reporting AEs (including fatal AEs) continues up to 30 days after the last 
dose of study drug. Deaths which occur more than 30 days after the last dose of study drug are to 
be reported if they are assessed by the Investigator as related to study drug. Fatal AEs meeting 
these criteria are SAEs and should be reported to the Sponsor or the Sponsor’s designee in 
accordance with the timelines specified in Section 10.2.5.
Deaths related to progression of the underlying disease during the study will not be reported as 
SAEs (see Section 10.2.2.6) if, in the Investigator’s judgment, the event is unequivocally because 
of the expected course of progression of the underlying disease, and not because of another 
cause.
10.2.4.
Reporting Exposure During Pregnancy
Pregnancy occurring in a female subject from start of the study and throughout the study 
(including the post study drug follow-up period) or within 6 months after the end of treatment, 
whichever is longer, should be reported to the Sponsor or the Sponsor’s designee on the 
Pregnancy Form within 24 hours of the Investigator’s becoming aware of the event. Pregnancy 
occurring in female partners of male subjects from start of the study and throughout the study 
(including the post study drug follow-up period) or within 3 months after the final dose, 
whichever is longer, should be reported to the Sponsor or the Sponsor’s designee within 24 hours 
of becoming aware of the event.
The Investigator should counsel the subject, and in the case of a male subject, the subject’s 
partner, regarding the risks of continuing with the pregnancy and the possible effects on the 
fetus.
If the female partner of a male subject becomes pregnant, the Investigator should obtain 
informed consent from the pregnant partner prior to monitoring the pregnancy, so that 
information regarding the pregnancy outcome can be reported to the Sponsor.
Information regarding the pregnancy should include estimated date of conception, duration of 
study drug exposure (or number of days/months after treatment discontinuation) as of the 
estimated conception date, expected delivery date, date of last menstrual period, all concomitant 
medications (including recreational drug use such as alcohol, tobacco, and illicit drugs) and other 
maternal medical conditions.
The Investigator should make every effort to follow the subject (or female partner of a male 
subject) through the resolution of the pregnancy, ie, delivery or pregnancy termination. If the 
pregnancy results in abortion (spontaneous or induced), or premature birth, or if the infant is 
born with a congenital anomaly, these events are considered SAEs and should be reported as 
described in Section 10.2.5. The outcome of all pregnancies must be reported to the Sponsor, 

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even for normal births. The condition of the infant at birth should be reported, including any 
anomalies, and the infant should be followed until 3 months of age and any illnesses should be 
reported.
All information regarding the pregnancy in a female subject or female partner of a male subject 
and the infant should be reported on the Pregnancy Form.
10.2.5.
Investigator Immediate Reporting Requirements
All SAEs and pregnancies must be reported to the Sponsor or the Sponsor’s designee 
immediately, and no later than 24 hours after becoming aware of the event.
In accordance with 10.2.2.1, all applicable SAEs will be recorded on the paper Initial SAE 
Report Form (Section 10.2.2.2) and transmitted by emailing or faxing the report form using the 
contact information below within 24 hours of the investigator’s knowledge of the event to the 
attention of the Sponsor. Any follow-up information for a previously reported SAE (including 
updates to the reported event term[s]) will be submitted to the Sponsor using the paper 
Follow-up SAE Report Form within 24 hours of the investigator’s knowledge of the follow-
up/updated information using the contact information below. Additionally, the SAE must be 
captured on the applicable CRFs.
Gilead Patient Safety
Email: Safety_FC@gilead.com
or
Fax: 1-650-522-5477
The Investigator is required to provide follow-up information in response to queries from the 
Sponsor or Sponsor’s designee. Hospital discharge summaries should be provided for subjects 
who are hospitalized and autopsy findings, if available, should be provided for subjects who die.
All SAEs and pregnancies must be reported to the Sponsor or the Sponsor’s designee by email 
provided in the SAE Completion Guidelines and the SAE Report Forms (initial and follow-up).
10.2.6.
Investigator Notification to Local Institutional Review Boards
The investigator will receive a safety letter or a quarterly SAE line listing notifying them of 
relevant suspected unexpected serious adverse reactions (SUSAR) reports associated with any 
study drug. The Investigator must notify their local institutional review boards 
(IRBs)/independent ethics committees (IECs) about certain AEs including SUSARs in 
accordance with the policies and procedures of their IRBs/IECs and International Council for 
Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
10.2.7.
Sponsor Responsibilities
The Sponsor or its designee will be responsible for reporting all AEs, SAEs and SUSARs to the 
appropriate regulatory authorities, Investigators, and central IRBs/IECs in accordance with all 
applicable regulations and guidance documents.

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10.3. 
Pharmacokinetics Evaluations 
FINAL 
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Blood for PK sennn samples will be collected from all subjects at pre-sacituzumab govitecan 
infusion and at EOI on Day 1 of Cycles 1, 2, 3, 7, 11, and eve1y 6 cycles thereafter (17, 23, etc), 
EOT with sacituzumab govitecan, and at the 30-Day Safety Follow-up Visit. There will be an 
additional collection pre-dose on C1D8. The collection window for PK samples is -30 minutes 
for predose (prior to staii of infusion), + 10 minutes for postdose samples (at EOI), and ±10 
minutes for all other timepoints. Serum concentration data for total antibody, total SN-38, free 
SN-38 and free SN-38G (metabolites of SN38) will be generated from sernm samples using 
assays perfo1med by the Sponsor's designee. 
PK samples for subjects continuing sacituzumab govitecan treatment following implementation 
of PAS will not be collected. 
10.4. 
Immunogenicity (Anti-drug Antibodies) Evaluations 
Immunogenicity will be assessed using a tiered approach (screen, confnmato1y , and titer) on 
study samples. Confnmed positive study samples will additionally be tested for hRS7 domain 
specificity and neutralizing ability. Blood for immunogenicity analysis (anti-diug antibody 
[ADA]) will be collected from all subjects at pre-sacituzumab govitecan infusion on Day 1 of 
Cycles 1, 2, 3, 7, 11, and eve1y 6 cycles thereafter (17, 23, etc), EOT with sacituzumab 
govitecan, and at the 30-Day Safety Follow-up Visit. Immunogenicity (ADA) will be evaluated 
in serum by the Sponsor's designee. All ADA samples will be collected predose with a collection 
window of -30 minutes prior to the staii of infusion. 
ADA samples for subjects continuing sacituzumab govitecan treatment following 
implementation of P A5 will not be collected. 
10.5. 
UGT1A1 Genotype 
UGTlAl genotype will be evaluated from the UGTlAl genotyping blood sample collected as 
specified in Table 2. This sample should be collected at the ClDl visit. If the sample is not 
collected at ClDl , then it can be collected at any other visit. 
UGTlAl genotyping blood samples for subjects continuing sacituzumab govitecan treatment 
following implementation of P A5 will not be collected . 
• 
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STATISTICS 
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Prima1y and seconda1y endpoints, populations for analysis, and statistical methods are described 
in this section. Additional details will be included in the statistical analysis plan (SAP). 
The primaiy endpoint is ORR according to RECIST 1.1 by the Investigator assessment. 
Seconda1y endpoints include ORR, DOR, CBR (defined as CR+ PR+ stable disease [SD] for at 
least 6 months), PFS according to RECIST 1.1 by BICR; DOR, CBR, and PFS according to 
RECIST 1. 1 by the Investigator's assessment; OS; the incidence of treatment-emergent AEs and 
clinical laborato1y abno1malities; and sennn concentrations of sacituzumab govitecan over time 
and incidence of ADA to sacituzumab govitecan. 
Summa1y tables and listings will be prepared using SAS®. Continuous data will be summarized 
using descriptive statistics: n, mean, median, standard deviation, minimum, and maximum. 
Categorical data will be summarized using frequency counts and percentages. Data listings will 
be created to suppo1i tables and figures. Any statistical analyses affected by the COVID-19 
pandemic will be detailed in the SAP. 
Statistical analyses will be perfo1med using SAS® (SAS Institute, Version 9.2 or later, Caiy, NC) 
and other software. 
11.1. 
Determination of Sample Size 
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This study was originally designed to limit enrollment to subjects with elevated TROP-2 
expression. In Amendment 2, the enrollment criterion for elevated TROP-2 expression was 
removed, and the study was expanded to include subjects with any level ofTROP-2 expression. 
Clinical activity will be conelated with TROP-2 expression assessed retrospectively. 
There were approximately 40 subjects enrolled in the NSCLC (adenocarcinoma and SCC) 
coho1is before the criteria ofTROP-2 expression was removed in Amendment 2 of the protocol. 
These subjects will not be counted toward the sample size above. Data from these subjects may 
be analyzed together with data from subjects enrolled under or after Amendment 2. 
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11.2. 
Efficacy Endpoint Definitions and Analyses 
FINAL 
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Efficacy analyses will be perfonned on all subjects who received at least 1 dose of sacituzumab 
govitecan. For sensitivity pmpose, selected efficacy endpoints including ORR, CBR, and PFS 
will also be analyzed based on the Response Evaluable population, which is defined as all 
emolled subjects who have received at least 1 dose of sacituzumab govitecan with a baseline 
radiologic assessment and at least 1 on-ti·eatment radiological assessment. 
Analysis will be conducted separately for each histologic cohort. The primaiy endpoint, ORR, is 
defined as the rate of the overall best response, CR or PR, based on the Investigator-assessed 
tumor response using RECIST 1.1 criteria for each histologic coho1t. ORR according to RECIST 
1.1 by BICR will be used as a secondaiy endpoint. The ORR rate will be calculated with a 
two-sided exact 95% CI using the Clopper-Peai·son method. 
The secondaiy endpoint, CBR, is defined as CR + PR + SD for at least 6 months, according to 
RECIST 1.1 by the Investigator's assessment or BICR. The CBR rate will be calculated with a 
two-sided exact 95% CI interval using the Clopper-Peai·son method. 
The secondaiy endpoint, PFS, is defined as the time from first dose until objective tumor 
progression or death, whichever comes first. Subjects not experiencing PD or not having died at 
the time of data cutoff or the database lock will have their event times censored at the last 
adequate tumor assessment. Tumor progression will be based on Investigator's assessment of 
tumor response according to RECIST 1.1. A Kaplan-Meier analysis will be perfo1m ed for the 
PFS data, and a 95% CI for the median PFS using the Brookmeyer-Crowley CI will be provided. 
If deemed necessaiy, PFS analyses according to RECIST 1.1 by BICR-assessed tumor response 
will also be produced. 
The secondaiy endpoint, DOR, is calculated as the date of the first evaluation showing 
documented response, either PR or CR, to the date of the first PD or death ( or date of last 
adequate response assessment in case objective PD is censored) according to RECIST 1.1 by the 
Investigator's assessment. A Kaplan-Meier analysis will be perfonned for the DOR data, and a 
95% Brookmeyer-Crowley CI for the median DOR will be provided. If deemed necessa1y, 
DOR analyses according to RECIST 1.1 by BICR-assessed tumor response will also be 
produced. 
The secondaiy endpoint OS is defined as the time from first dose to death due to all causes. 
Subjects not having died at the time of the data cutoff or the database lock will have their event 
times censored on the last date of their known alive date. A Kaplan-Meier analysis will be 
perfo1med for OS, and a 95% CI for the median OS using Brookmeyer-Crowley CI will be 
provided. 
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11.3.
Safety Analyses
All subjects administered at least 1 dose of sacituzumab govitecan will be included in the 
evaluation of safety.
Safety will be evaluated based on AEs, standard safety laboratories (CBC with differential), 
serum chemistries, and urinalysis (if clinically indicated).
The total amount of study drug and number of cycles and doses received will be summarized by 
the histological cohort.
The frequency and severity of AEs, classified by Medical Dictionary for Regulatory Activities 
(MedDRA), will be summarized overall and by histological cohort using MedDRA Preferred 
Term (PT) and System Organ Class (SOC). An AE that occurs more than once within each 
subject will be counted only once in the summaries, using the worst NCI-CTCAE grade and 
relationship category. AEs will be consolidated using the worst NCI-CTCAE grade and 
relationship category observed for classification into each MedDRA SOC summary.
AEs leading to death or to discontinuation from treatment as well as all SAEs will be 
summarized or listed separately. A listing of all death information will be generated. The reasons 
for study treatment discontinuation will also be summarized for each histological cohort.
Routine safety laboratories, based on hematology and routine serum chemistry data (glucose, 
creatinine, BUN, total bilirubin, AST, ALT, LDH, uric acid, alkaline phosphatase, serum 
albumin, total protein, sodium, potassium, calcium, chloride, bicarbonate, magnesium, and 
phosphorus), will be summarized using values at each visit and change from baseline using 
descriptive statistics for each histological cohort.
Laboratory test results for platelets, neutrophils, white blood count, lymphocytes and hemoglobin 
will be graded according to NCI-CTCAE severity grade. The worst NCI-CTCAE grade observed 
on-treatment will be tabulated for each laboratory parameter and presented in a frequency table 
by baseline grade. For parameters for which an NCI-CTCAE scale does not exist, the proportion 
of subjects with abnormal values will be summarized by histological cohort.

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11.4. 
Pharmacokinetics Analyses 
FINAL 
Amendment5 
Sernm concentrations of sacituzumab govitecan, free SN-38, total antibody and SN-38G will be 
summarized over each scheduled sampling time and PK analysis will be perfo1med using 
available data from all subjects. The PK parameters to be estimated and repo1ted may include, 
but may not be limited to, maximum observed diug concentration (Cmax), area under the 
concentration time curve (AUC0_168J, and time (observed time point) to Cmax (TmaJ for subjects 
with adequate sernm concentration data, if feasible. 
Data from this study may be combined with data from other studies with sacituzumab govitecan 
for population PK and exposure-response analyses. If applicable, results from such analyses may 
be summarized in a separate repo1t, rather than in a clinical study repo1t. Population PK and 
exposure-response analyses of data from this study only may not be conducted. 
11.5. 
Immunogenicity (Anti-Drug Antibodies) Analyses 
The rate and magnitude of ADA incidence, prevalence, persistence, and transience will be 
characterized b descri tive statistics and summarized. Titer summaries ma also be enerated, 
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12.
ADMINISTRATIVE AND ETHICAL REQUIREMENTS
12.1.
Good Clinical Practice
The study will be conducted in accordance with the ICH E6 for GCP guidelines and the 
appropriate local and national regulatory requirement(s). The Investigator will be thoroughly 
familiar with the appropriate use of the study drugs as described in the protocol and 
Investigator’s Brochure.
Essential clinical documents will be maintained to permit evaluation of the conduct of the study 
and the integrity of the data collected. Master files for this study should be established at the 
beginning of the study, maintained for the duration of the study, and retained according to the 
appropriate regulations.
12.2.
Ethical Considerations
This study is a global study and will be conducted in North America, Europe, Asia-Pacific, and 
potentially other regions. Regulatory agencies require that the study be conducted in accordance 
with ethical principles founded in the Declaration of Helsinki. The study will be performed in 
accordance with ICH GCP guidelines, the Declaration of Helsinki, 18th World Medical 
Assembly, Helsinki, Finland, 1964 and later revisions, and applicable local regulatory 
requirements and laws. In the US, ethical protection is provided by compliance with ICH GCP 
guidelines and 21 Code of Federal Regulations (CFR) 50 (Protection of Human Subjects).
The IRB/IEC will review all appropriate study documentation to safeguard the rights, safety, and 
well-being of the subjects. The study will only be conducted at sites where IRB/IEC approval has 
been obtained.
The Investigator is responsible for providing their IRB/IEC with any required study documents, 
progress reports, and safety updates and is responsible for notifying the IRB/IEC promptly of all 
SAEs occurring at the site as required by the IRB/IEC.
All correspondence with the IRB/IEC should be retained in the Investigator File. Copies of 
IRB/IEC approvals should be forwarded to the Sponsor or the designee.
The only circumstance in which an amendment may be initiated prior to IRB/IEC approval is 
where the change is necessary to eliminate apparent immediate hazards to the subjects. In that 
event, the Investigator must notify the IRB/IEC and the Sponsor or its designee in writing within 
5 working days after the implementation.

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12.3.
Subject Information and Consent
It is the responsibility of the Investigator to give each subject (or the subject’s legally authorized 
representative) full and adequate verbal and written information regarding the objective and 
procedures of the study including the possible risks and benefits involved. Written subject 
information, approved by the IRB/IEC, must be given to each subject before any study-related 
procedure is undertaken. During the consent process, the subject must be informed about their 
right to withdraw from the study at any time. The subject must also be given ample time to read 
the written informed consent form and have all study-related questions answered to the 
satisfaction of the subject (or the subject’s legally acceptable representative). It is the 
responsibility of the Investigator to obtain a signature from each subject, the subject’s legally 
acceptable representative (if applicable), and from the persons conducting the informed consent 
discussion prior to undertaking any study-related procedure. The subject (or the subject’s legally 
acceptable representative) must be given a copy of the signed and dated informed consent form.
The Investigator is also responsible for providing the subject (or the subject’s legally acceptable 
representative) with any clinical study updates that may affect the subject’s willingness to 
continue participation in the study. The informed consent process must be documented in the 
subject’s medical or source chart. The written subject information must not be changed without 
prior approval by the Sponsor or its designee and the IRB/IEC.
Per ICH E6 4.3.3, it is recommended that the Investigator notify the subject’s general 
practitioner/primary care physician (PCP) of the subject’s participation in the study if the subject 
agrees to the Investigator informing their PCP.
12.4.
Protocol Compliance
The Investigator will conduct the study in compliance with the protocol provided by the Sponsor 
or its designee and approved by the IRB/IEC and the appropriate regulatory authority. 
Modifications to the protocol should not be made. Changes to the protocol will require written 
IRB/IEC approval prior to implementation, and acceptance by the appropriate regulatory health 
authority, except when the modification is needed to eliminate an immediate hazard(s) to the 
subject. The IRB/IEC may provide, and if applicable regulatory authorities’ approval, expedited 
review and approval for any minor change(s) in this ongoing study that has the approval of the 
IRB/IEC. The Sponsor’s designee will submit all protocol modifications to the regulatory 
authorities in accordance with the governing regulations.
When immediate deviation from the protocol is required to eliminate any immediate hazard(s) to 
subjects, the Investigator will contact the Sponsor’s designee, if circumstances permit, and their 
local IRB/IEC if required, to discuss the planned course of action. Any departures from the 
protocol must be fully documented as a protocol deviation within source documentation.

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12.5.
Site Monitoring and On-Site Audits
Monitoring and auditing procedures developed by the Sponsor or its designee will be followed, 
to comply with ICH GCP guidelines; the US Food and Drug Administration (FDA) guidance, the 
European Medicines Agency (EMA), and all applicable guidelines. Review of subject’s eCRFs, 
Electronic Medical Records or paper source documentation for completeness, and accuracy will 
be required. In addition, a review of all applicable regulatory documents will be performed 
according to the monitoring plan. All available source documents should be obtained by the 
Investigator and provided to the Sponsor’s designee at each monitoring visit.
The Site Monitor may also issue queries in the eCRF system to be addressed by the appropriate 
study site personnel in a timely manner when clarification of eCRF data is required to ensure 
data accuracy and completeness. The Site Monitor will ensure that the investigation is conducted 
according to protocol design and regulatory requirements through frequent communication.
Regulatory authorities, the IRB/IEC, and/or the Sponsor’ clinical quality assurance group or 
designee may request access to all source documents, subject’s eCRFs, and other study 
documentation for onsite audit or inspection. Direct access, or remote access when permissible 
and deemed necessary, to these documents must be guaranteed by the Investigator, who must 
always provide cooperation and support for these activities.
12.6.
Subject Data Protection
Enterprise level technical and organizational controls have been developed at Gilead for the 
purpose of data protection. This includes user authentication and identification, fine grained 
access controls, end-to-end data encryption, security monitoring, network segregation, and 
physical security controls. Users of Gilead systems are provided training for security awareness 
and privacy.
To prepare for the possibility of a data security breach, Gilead maintains a business continuity 
and disaster recovery plan and conducts regular disaster recovery testing to ensure that Gilead 
systems are recoverable if a cyber or data security incident is experienced. Gilead’s detailed 
incident response plan for any cyber or data security incident is based on the following 5 steps: 
detection, analysis, containment, eradication, and recovery.
Information collected in this clinical study is subject to the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) as described in 45 CFR Part 160 and 45 CFR Part 164 
(on the protection of natural persons with regard to the processing of personal data and on the 
free movement of such data). The study Investigator is responsible for informing subjects of their 
rights under HIPAA and General Data Protection and obtaining any necessary HIPAA 
authorizations. In compliance with the provisions of that policy, the Sponsor or designee will not 
collect any protected health information and will only collect de-identified health information. 
Any clinical study information referred to in this section is understood to be compliant with the 
provisions of the Privacy Act. The information obtained during the conduct of this clinical study 
is confidential, and disclosure to third parties other than those noted below is prohibited.

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Information obtained during the conduct of this study will be used by the Sponsor or designee in 
connection with the development of the study drug. The study Investigator is obliged to provide 
the Sponsor or designee with complete test results and all data developed in this study. This 
information may be disclosed to other physicians participating in the study, to the FDA, or to 
national and local health authorities. To ensure compliance with all current Federal Regulations 
and the ICH GCP guidelines, data generated by this study must be available for inspection upon 
request by representatives of the FDA, national and local health authorities, the Sponsor, their 
designee, and the IRB/IEC for each study site.
Gilead and institutions will both act in accordance with the applicable data protection law. 
Furthermore, the study site and Gilead will cooperate with each other to take the necessary 
measures in order to comply with the applicable data protection law. Both Gilead and the study 
site shall implement appropriate technical and organizational measures to meet the requirements 
of the EU General Data Protection Regulation. If either party becomes aware of a personal data 
breach related to data processed under this agreement, that party shall promptly notify the other 
party. In such a case, parties will fully cooperate with each other to remedy the personal data 
breach and promptly fulfill the (statutory) notification obligations. A personal data breach refers 
to a personal data breach as described in Article 4, Article 33, and Article 34 of the EU General 
Data Protection Regulation and applicable national data protection laws.
12.7.
Financial Disclosure
In accordance with 21 CFR Part 54, FDA requires that certain financial interests and 
arrangements between Sponsors of clinical investigations be disclosed in marketing applications. 
Because the results of this study may eventually be used in a marketing application, compliance 
with this Federal statute is essential. To comply with the provisions of this regulation, the 
Sponsor requests that every Investigator and sub-Investigator mentioned on FDA Form 1572 fill 
out a financial disclosure form. Under the provisions of 21 CFR Part 54, the term clinical 
Investigator includes the spouse and each dependent child of the Investigator.
The provisions of 21 CFR Part 54 specify disclosure of significant equity interests in the Sponsor 
that exceed $50,000, or significant payments of other sorts made by the Sponsor to the 
Investigators that have a monetary value of more than $25,000, exclusive of the costs of 
conducting the clinical study or other clinical studies (eg, grants to fund ongoing research, 
compensation in the form of equipment or retainers for ongoing consultation), during the time 
the Investigator is carrying out the study or for 1 year following the completion of the study. If a 
change in financial interest occurs throughout the study, the Investigator is obligated to notify the 
Sponsor. To assist the Sponsor or designee in providing the FDA with the required information, 
Investigators are asked to complete the financial disclosure form and return a signed copy. All 
information provided in the financial disclosure form will be regarded as strictly confidential and 
will only be disclosed to the FDA.

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12.8.
Sponsor Discontinuation Criteria
The Sponsor reserves the right to discontinue the study prior to inclusion of the intended number 
of subjects but intends only to exercise this right for valid scientific or administrative reasons. 
After such a decision, the Investigator must contact all participating subjects within a period of 
time specified by the Sponsor. In the unlikely event of premature termination or discontinuation 
of the study, or in the event the Investigator believes a subject is continuing to receive clinical 
benefit, the Sponsor will discuss options with the Investigator to ensure continuing supply of 
sacituzumab govitecan. As directed by the Sponsor’s designee, all study materials will be 
collected and all eCRFs completed to the greatest extent possible.

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13.
QUALITY CONTROL AND QUALITY ASSURANCE
The Sponsor has ethical, legal, and scientific obligations to follow this study carefully in a 
detailed and orderly manner in accordance with established research principles and applicable 
regulations.
Monitoring visits to the study site will be conducted periodically during the study to ensure that 
GCP guidelines and all aspects of the protocol are followed. The study site may also be subject 
to review by the IRB/IEC, to quality assurance audits performed by the Sponsor’s designee, 
and/or to inspection by appropriate regulatory authorities. Investigators and their relevant 
personnel must agree to be available and participate with visits conducted at a reasonable time in 
a reasonable manner, and the Investigator/Institution must guarantee direct access to source 
documents by the Sponsor and its designee, and appropriate regulatory authorities.
Regulatory authorities worldwide may also inspect the Investigator during or after the study. The 
Investigator should contact the Sponsor’s designated contact immediately if this occurs and must 
fully cooperate with regulatory authority inspections conducted at a reasonable time in a 
reasonable manner.

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14.
DATA HANDLING AND RECORD KEEPING
14.1.
Electronic Case Report Forms (eCRFs)
An eCRF is required and must be completed for each enrolled subject. The completed original 
eCRFs are the sole property of the Sponsor and should not be made available in any form to third 
parties, except for authorized representatives of appropriate regulatory authorities, without 
written permission from the Sponsor.
It is the Investigator's responsibility to ensure completion and to review and approve all eCRFs, 
which must be signed by the Investigator. These signatures serve to attest that the information 
contained on the eCRFs is true. At all times, the Investigator has final personal responsibility for 
the accuracy and authenticity of all clinical and laboratory data entered on the eCRFs. The 
subject’s source documents are the treating physician’s subject records maintained at the study 
site. In most cases, the source documents will be the hospital’s or the physician’s chart. In cases 
where the source documents are the hospital or the physician’s chart, the information collected 
on the eCRFs must match those charts. The identification of any data to be recorded directly on 
the eCRFs (ie, no prior written or electronic record of data), and to be considered to be source 
data will be specified in this protocol.
Queries will be issued in the eCRF system by the Sponsor or designee in cases where 
clarification of eCRF data entered by the study site is required. The appropriate study site 
personnel must address all queries in a timely manner during the study and afterwards to ensure 
data accuracy and completeness.
14.2.
Retention of Records
Records and documents pertaining to the conduct of this study, including eCRFs, source 
documents, consent forms, laboratory test results, and study drug inventory records must be 
retained by the Investigator as per local regulations. No study records shall be destroyed without 
prior authorization from the Sponsor. For studies conducted outside the US under an 
investigational new drug (IND) application, the Investigator must also comply with US FDA 
IND regulations, ICH guidelines, and with the regulations of the relevant national and local 
health authorities. Current US federal law requires an Investigator to maintain such records for a 
period of 2 years after approval of a Biologic License Application, or, if the Biologic License 
Application is not approved, until 2 years after notification by the Sponsor that the clinical 
investigations have been discontinued.

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15.
PUBLICATION POLICY
The conditions regulating dissemination of the information derived from this clinical study are 
described in the Clinical Trial Agreement.
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies) when 
applicable and in accordance with local regulatory requirements. Gilead will ensure that the 
report meets the standards set out in the ICH Guideline for Structure and Content of Clinical 
Study Reports (ICH E3). Note that an abbreviated report may be prepared in certain cases. For 
studies with sites in countries following the EU Regulation No. 536/2014, a CSR will be 
submitted within 1 year (6 months for pediatric studies, in accordance with Regulation [EC] 
No. 1901/2006) after the global end of study (as defined in Section 4.8).
Investigators in this study may communicate, orally present, or publish study data in scientific 
journals or other scholarly media in accordance with the Gilead clinical trial agreement. Study 
results will be made publicly available (including posted to the Clinical Trials Information 
System and ClinicalTrials.gov) in accordance with local regulatory requirements.

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16.
REFERENCES
Alberti S, Trerotola M, Vacca G, Zappacosta R, Rossi C, Bonasera EG, et al. TROP2 is a major 
determinant of growth and metastatic spreading of human cancer. Journal of 
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Baize N, Monnet I, Greillier L, Geier M, Lena H, Janicot H, et al. Carboplatin plus etoposide 
versus topotecan as second-line treatment for patients with sensitive relapsed 
small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial. 
Lancet Oncol 2020;21 (9):1224-33.
Bardia A, Mayer IA, Diamond JR, Moroose RL, Isakoff SJ, Starodub AN, et al. Efficacy and 
Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-
132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast 
Cancer. J Clin Oncol 2017;35 (19):2141-8.
Bardia A, Messersmith WA, Kio EA, Berlin JD, Vahdat L, Masters GA, et al. Sacituzumab 
govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial 
cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket 
trial [Supplementary Appendix]. Ann Oncol 2021;32 (6):746-56.
CAMPTOSAR, Pharmacia and Upjohn Co. CAMPTOSAR® (irinotecan) injection, for 
intravenous use. U.S. Prescribing Information. NY, NY. Revised January.  2020:
Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Arrojo R, Liu D, et al. Sacituzumab 
govitecan (IMMU-132), an anti-trop-2/SN-38 antibody-drug conjugate: 
characterization and efficacy in pancreatic, gastric, and other cancers. Bioconjug 
Chem 2015;26 (5):919-31.
Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Goldenberg DM. Humanized anti-Trop-2 
IgG-SN-38 conjugate for effective treatment of diverse epithelial cancers: 
preclinical studies in human cancer xenograft models and monkeys. Clin Cancer 
Res 2011;17 (10):3157-69.
Cohen EEW, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, et al. Pembrolizumab 
versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-
and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, 
phase 3 study. Lancet 2019;393 (10167):156-67.
Cubas R, Li M, Chen C, Yao Q. Trop2: a possible therapeutic target for late stage epithelial 
carcinomas. Biochim Biophys Acta 2009;1796 (2):309-14.
Cubas R, Zhang S, Li M, Chen C, Yao Q. Trop2 expression contributes to tumor pathogenesis by 
activating the ERK MAPK pathway. Mol Cancer 2010;9:253.

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Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New Response 
Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (Version 1.1). 
Eur J Cancer 2009;45 (2):228-47.
Fang YJ, Lu ZH, Wang GQ, Pan ZZ, Zhou ZW, Yun JP, et al. Elevated expressions of MMP7, 
TROP2, and survivin are associated with survival, disease recurrence, and liver 
metastasis of colon cancer. Int J Colorectal Dis 2009;24 (8):875-84.
Ferris RL, Blumenschein G, Jr., Fayette J, Guigay J, Colevas AD, Licitra L, et al. Nivolumab vs 
investigator's choice in recurrent or metastatic squamous cell carcinoma of the 
head and neck: 2-year long-term survival update of CheckMate 141 with analyses 
by tumor PD-L1 expression. Oral Oncol 2018;81:45-51.
Fong D, Moser P, Krammel C, Gostner JM, Margreiter R, Mitterer M, et al. High expression of 
TROP2 correlates with poor prognosis in pancreatic cancer. Br J Cancer 2008a;99 
(8):1290-5.
Fong D, Spizzo G, Gostner JM, Gastl G, Moser P, Krammel C, et al. TROP2: a novel prognostic 
marker in squamous cell carcinoma of the oral cavity. Mod Pathol 2008b;21 
(2):186-91.
Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target 
for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-
drug conjugate (ADC). Oncotarget 2015;6 (26):22496-512.
Govindan SV, Cardillo TM, Sharkey RM, Tat F, Gold DV, Goldenberg DM. Milatuzumab-SN-
38 conjugates for the treatment of CD74+ cancers. Mol Cancer Ther 2013;12 
(6):968-78.
Gray JE, Heist RS, Starodub AN, Camidge DR, Kio EA, Masters GA, et al. Therapy of Small 
Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug 
Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Clin Cancer Res 
2017;23 (19):5711-9.
Guerra E, Trerotola M, Dell' Arciprete R, Bonasera V, Palombo B, El-Sewedy T, et al. A 
bicistronic CYCLIN D1-TROP2 mRNA chimera demonstrates a novel oncogenic 
mechanism in human cancer. Cancer Res 2008;68 (19):8113-21.
Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, von Pawel J, et al. Randomized 
phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung 
cancer previously treated with chemotherapy. J Clin Oncol 2004;22 (9):1589-97.
Heist RS, Guarino MJ, Masters G, Purcell WT, Starodub AN, Horn L, et al. Therapy of 
Advanced Non-Small-Cell Lung Cancer With an SN-38-Anti-Trop-2 Drug 
Conjugate, Sacituzumab Govitecan. J Clin Oncol 2017;35 (24):2790-7.

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Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, et al. Nivolumab Versus 
Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung 
Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III 
Trials (CheckMate 017 and CheckMate 057). J Clin Oncol 2017;35 (35):3924-33.
Kobayashi H, Minami Y, Anami Y, Kondou Y, Iijima T, Kano J, et al. Expression of the GA733 
gene family and its relationship to prognosis in pulmonary adenocarcinoma. 
Virchows Arch 2010;457 (1):69-76.
Köbel M, Kalloger SE, Boyd N, McKinney S, Mehl E, Palmer C, et al. Ovarian carcinoma 
subtypes are different diseases: implications for biomarker studies. PLoS Med 
2008;5 (12):e232.
Lopez S, Perrone E, Bellone S, Bonazzoli E, Zeybek B, Han C, et al. Preclinical activity of 
sacituzumab govitecan (IMMU-132) in uterine and ovarian carcinosarcomas. 
Oncotarget 2020;11 (5):560-70.
Mazieres J, Rittmeyer A, Gadgeel S, Hida T, Gandara DR, Cortinovis DL, et al. Atezolizumab 
Versus Docetaxel in Pretreated Patients With NSCLC: Final Results From the 
Randomized Phase 2 POPLAR and Phase 3 OAK Clinical Trials. Journal of 
Thoracic Oncology 2021;16 (1):140-50.
Merck. KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Significantly Improved 
Progression-Free Survival and Overall Survival Versus Chemotherapy in Patients 
With Advanced Endometrial Cancer Following Prior Platinum-Based 
Chemotherapy in Phase 3 Study [Press Release] 19 March.  2021:
Ocean AJ, Starodub AN, Bardia A, Vahdat LT, Isakoff SJ, Guarino M, et al. Sacituzumab 
govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the 
treatment of diverse epithelial cancers: Safety and pharmacokinetics. Cancer 
2017;123 (19):3843-54.
Ohmachi T, Tanaka F, Mimori K, Inoue H, Yanaga K, Mori M. Clinical significance of TROP2 
expression in colorectal cancer. Clin Cancer Res 2006;12 (10):3057-63.
Paz-Ares L. Lurbinectedin/Doxorubicin versus CAV or Topotecan in Relapsed SCLC Patients: 
Phase III Randomized ATLANTIS Trial [Abstract]. World Conference on Lung 
Cancer (WCLC) Virtual; 2021 08-14 September. 
Perrone E, Lopez S, Zeybek B, Bellone S, Bonazzoli E, Pelligra S, et al. Preclinical Activity of 
Sacituzumab Govitecan, an Antibody-Drug Conjugate Targeting Trophoblast 
Cell-Surface Antigen 2 (Trop-2) Linked to the Active Metabolite of Irinotecan 
(SN-38), in Ovarian Cancer. Front Oncol 2020;10:118.
Sharkey RM, McBride WJ, Cardillo TM, Govindan SV, Wang Y, Rossi EA, et al. Enhanced 
Delivery of SN-38 to Human Tumor Xenografts with an Anti-Trop-2-SN-38 

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Antibody Conjugate (Sacituzumab Govitecan). Clin Cancer Res 2015;21 
(22):5131-8.
Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, et al. Prospective 
randomized trial of docetaxel versus best supportive care in patients with non-
small-cell lung cancer previously treated with platinum-based chemotherapy. J 
Clin Oncol 2000;18 (10):2095-103.
Shih LB, Thorpe SR, Griffiths GL, Diril H, Ong GL, Hansen HJ, et al. The processing and fate 
of antibodies and their radiolabels bound to the surface of tumor cells in vitro: a 
comparison of nine radiolabels. J Nucl Med 1994;35 (5):899-908.
Shvartsur A, Bonavida B. Trop2 and its overexpression in cancers: regulation and 
clinical/therapeutic implications. Genes Cancer 2015;6 (3-4):84-105.
Smith TJ, Bohlke K, Lyman GH, Carson KR, Crawford J, Cross SJ, et al. Recommendations for 
the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical 
Practice Guideline Update. J Clin Oncol 2015;33 (28):3199-212.
Spigel DR, Vicente D, Ciuleanu TE, Gettinger S, Peters S, Horn L, et al. Second-line nivolumab 
in relapsed small-cell lung cancer: CheckMate 331(). Ann Oncol 2021;32 (5):631-
41.
Stein R, Goldenberg DM, Thorpe SR, Basu A, Mattes MJ. Effects of radiolabeling monoclonal 
antibodies with a residualizing iodine radiolabel on the accretion of radioisotope 
in tumors. Cancer Res 1995;55 (14):3132-9.
Stepan LP, Trueblood ES, Hale K, Babcook J, Borges L, Sutherland CL. Expression of Trop2 
cell surface glycoprotein in normal and tumor tissues: potential implications as a 
cancer therapeutic target. J Histochem Cytochem 2011;59 (7):701-10.
Trerotola M, Rathore S, Goel HL, Li J, Alberti S, Piantelli M, et al. CD133, Trop-2 and 
alpha2beta1 integrin surface receptors as markers of putative human prostate 
cancer stem cells. Am J Transl Res 2010;2 (2):135-44.
Wu H, Xu H, Zhang S, Wang X, Zhu H, Zhang H, et al. Potential therapeutic target and 
independent prognostic marker of TROP2 in laryngeal squamous cell carcinoma. 
Head & neck 2013;35 (10):1373-8.
Zeybek B, Manzano A, Bianchi A, Bonazzoli E, Bellone S, Buza N, et al. Cervical carcinomas 
that overexpress human trophoblast cell-surface marker (Trop-2) are highly 
sensitive to the antibody-drug conjugate sacituzumab govitecan. Scientific reports 
2020;10 (1):973.

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17.
APPENDICES

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17.1.
Investigator Signature Page
INVESTIGATOR STATEMENT
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated.
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the study drugs and the study.
Principal Investigator Name (Printed)
Signature
Date
Site Number

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17.2.
Performance Status Criteria
ECOG Performance Status Scale
Grade
Descriptions
0
Normal activity
Fully active, able to carry on all pre-disease performance without restriction
1
Symptoms, but ambulatory
Restricted in physically strenuous activity, but ambulatory and able to carry out work of a 
light or sedentary nature (eg, light housework, office work)
2
In bed <50% of the time
Ambulatory and capable of all self-care, but unable to carry out any work activities, up 
and about more than 50% of waking hours
3
In bed >50% of the time
Capable of only limited self-care, confined to bed or chair more than 50% of waking 
hours
4
100% bedridden
Completely disabled
Cannot carry on any self-care
Totally confined to bed or chair
5
Dead

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17.3.
Cockcroft-Gault Formula
CCr={((140–age) x weight)/(72xSCr)} x 0.85 (if female)
Abbreviations/Units
CCr (creatinine clearance) = mL/minute
Age = years
Weight = kg
SCr (serum creatinine) = mg/dL
References
1) Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. 
Nephron. 1976. 16(1):31-41.

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17.4.
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
New Response evaluation criteria in Solid tumors: Revised RECIST criteria {Eisenhauer 2009} 
are summarized below. Timing of assessments has been modified to fit this protocol.
Measurable/Non-Measurable Lesions: Each tumor lesion or site of disease identified at 
baseline is categorized as either a measurable lesion or a non-measurable lesion according to the 
following definitions.
Lesion Type
Qualifying Definition
Measurable
Tumor lesions: Must be accurately measured in ≥ 1 dimension (longest 
diameter in the plane of measurement is to be recorded) with a minimum size 
of:
•
10 mm by CT scan (CT scan slice thickness no greater than 5 mm).
•
10 mm caliper measurement by clinical exam (lesions which cannot be 
accurately measured with calipers should be recorded as non-measurable)
•
20 mm by chest X-ray.
Malignant lymph nodes: To be considered pathologically enlarged and 
measurable, a lymph node must be 15 mm in short axis when assessed by 
CT scan (CT scan slice thickness recommended to be no greater than 5 mm). 
At baseline and in follow-up, only the short axis will be measured and 
followed.
Non-Measurable
All other lesions, including small lesions (longest diameter < 10 mm or 
pathological lymph nodes with 10 to < 15 mm short axis) as well as truly 
non-measurable lesions. Lesions considered truly non-measurable include 
leptomeningeal disease, ascites, pleural, or pericardial effusion, inflammatory 
breast disease, lymphangitic involvement of skin or lung, and abdominal 
masses/abdominal organomegaly identified by physical exam that is not 
measurable by reproducible imaging techniques.
Special considerations regarding lesion measurability:
Bone lesions, cystic lesions, and lesions previously treated with local therapy require particular 
comment.
Bone lesions:
•
Bone scan, positron emission tomography (PET) scan, or plain films are not considered 
adequate imaging techniques to measure bone lesions. However, these techniques can be 
used to confirm the presence or disappearance of bone lesions.
•
Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, 
that can be evaluated by cross-sectional imaging techniques such as CT or MRI scan can be 
considered as measurable lesions if the soft tissue component meets the definition of 
measurability described above.

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Blastic bone lesions are non-measurable. Cystic lesions:
•
Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) because they are, 
by definition, simple cysts.
•
‘Cystic lesions’ thought to represent cystic metastases can be considered as measurable 
lesions, if they meet the definition of measurability described above. However, if non-cystic 
lesions are present in the same subject, these are preferred for selection as target lesions.
Lesions with prior local treatment: Tumor lesions situated in a previously irradiated area, or in an 
area subjected to other loco-regional therapy, are usually not considered measurable unless there 
has been demonstrated progression in the lesion. All measurements should be recorded in metric 
notation, using calipers if clinically assessed. All baseline evaluations should be performed after 
the subject has provided written informed consent and as close as possible to the treatment start.
Target Lesions: Target lesions are selected from measurable lesions at baseline based on their 
size and suitability for accurate repeated measurements by imaging techniques or clinical 
judgment. The sum of the longest diameter (LD) for all target lesions provides a quantitative 
means of characterizing objective tumor response to treatment as follows:
Evaluation Criteria Used for Categorizing Treatment Response of Target Lesions
Response Category
Definition
Complete Response
(CR)
Disappearance of all target lesions
Partial Response (PR)
> 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as 
reference the baseline sum LD
Progressive Disease (PD)
> 20% increase in the sum of diameters of target lesions, taking as reference the 
smallest sum on study (this includes the baseline sum if that is the smallest on 
study). In addition to the relative increase of 20%, the sum must also demonstrate an 
absolute increase of ≥ 5 mm. (Note: The appearance of ≥ 1 new lesions is also 
considered progression)
Stable Disease
(SD)
Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for 
PD, taking as reference the smallest sum LD since the treatment started

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Non-Target Lesions: Non-target lesions are other lesions (or sites of disease) not identified as 
target lesions at baseline. These include both non-measurable lesions as well as measurable lesions 
exceeding the maximum number allowed per organ or in total. The response of non-target lesions 
to treatment is evaluated based on their presence or absence as follows:
Evaluation Criteria Used for Categorizing Treatment Response of Non-Target Lesions
Response Category
Definition
Complete Response
(CR)
Disappearance of all non-target lesions and normalization of tumor marker levels initially 
above upper limits of normal
Progressive Disease (PD)
Appearance of ≥ 1 new lesions and/or unequivocal progression of existing non-target lesions
Stable Disease
(SD)
Persistence of ≥ 1 non-target lesion(s) or/and maintenance of tumor marker level above the 
normal limits
New Lesions: New lesions not present at baseline should be recorded at time of occurrence.
Overall Response: The overall response is the best response recorded from the start of the 
treatment until disease progression or recurrence (taking as reference for progressive disease the 
smallest measurements recorded since the treatment started). To be assigned a status of PR or 
CR, changes in tumor measurements must be confirmed by repeat assessments 4 to 6 weeks after 
initial documentation. In the case of SD, follow-up measurements must have met the SD criteria 
at least once with a minimum interval of at least 6 to 8 weeks from enrollment.
Target Lesions
Non-target Lesions
New Lesions
Overall Response
CR
CR
No
CR*
CR
Incomplete response/SD
No
PR
PR
Non-PD
No
PR
SD
Non-PD
No
SD
PD
Any
Yes or No
PD**
Any
PD
Yes or No
PD**
Any
Any
Yes
PD**
CR = complete response; PD = progressive disease; PR = partial response; SD = stable disease.
*When evaluation of possible CR depends on distinguishing residual disease from normal tissue, fine needle aspirate/biopsy is 
recommended before confirming the complete response status.
**Subjects without objective evidence of disease progression, but with globally deteriorated health status requiring 
discontinuation of treatment should be classified as having “symptomatic deterioration” at that time, with every effort made to 
document the objective progression, even after discontinuation of treatment.
Duration of Response: The duration of overall response is measured from the time 
measurement criteria are met for CR or PR (whichever is first recorded) until the first date that 
recurrent or progressive disease is objectively documented (taking as reference for progressive 
disease the smallest measurements recorded since the treatment started). Stable disease is 
measured from the start of the treatment until the criteria for progression are met, taking as 
reference the smallest measurements recorded since the treatment started.

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17.5.
Pregnancy Precautions, Definitions of Childbearing Potential, and 
Contraceptive Requirements
1)
Definitions
a.
Definition of Childbearing Potential
For the purposes of this study, a patient assigned female at birth is considered of childbearing 
potential following the initiation of puberty (Tanner stage 2) until becoming postmenopausal 
unless the subject is permanently sterile or has medically documented ovarian failure.
Patients are considered to be in a postmenopausal state when they are at least 54 years of age 
with cessation of previously occurring menses for at least 12 months without an alternative 
cause. In addition, patients younger than 54 years with amenorrhea of at least 12 months also 
may be considered postmenopausal if their follicle-stimulating hormone level is in the 
postmenopausal range and they are not using hormonal contraception or hormonal replacement 
therapy.
Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female patient of any age.
b.
Definition of Fertility in a Participant Assigned Male at Birth
For the purposes of this study, a patient assigned male at birth is considered fertile after the 
initiation of puberty unless the patient is permanently sterile by bilateral orchidectomy or 
medical documentation.
2)
Contraception Requirements for Patients Assigned Female at Birth and of 
Childbearing Potential
a.
Study Drug Effects on Pregnancy and Hormonal Contraception
Sacituzumab govitecan is contraindicated in pregnancy because a malformative effect has been 
demonstrated/suspected or is unknown, taking into consideration class effects and genotoxic 
potential. Based on the assessment of published data related to CYP450 enzyme inhibition and 
induction experiments for SN-38, efficacy of hormonal contraception is not expected to be 
impacted due to sacituzumab govitecan administration. A dedicated oral contraceptive drug-drug 
interaction clinical study has not been conducted. Refer to the latest version of the Investigator’s 
Brochure for additional information.
b.
Contraception Requirements for Female Subjects of Childbearing Potential
The inclusion of female subjects of childbearing potential requires the use of highly effective 
contraceptive measures that have a failure rate of less than 1% per year. Subjects must have a 
negative serum pregnancy test during screening and a negative urine pregnancy test is required at 
baseline prior to study treatment administration on Cycle 1 Day 1 (C1D1). The baseline urine 
pregnancy test does not need to be conducted if the screening pregnancy test was performed 
within 72 hours before study treatment administration on C1D1. Pregnancy tests will be 
performed thereafter on Day 1 of each treatment cycle starting from Cycle 2 through last cycle 

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and every 28 days after the last dose of study drug until the end of contraception requirement. If 
a urine test is positive or equivocal, a confirmatory serum pregnancy test will be required.
Duration of required contraception for female subjects in this clinical study should start from the 
Screening Visit until 6 months after the last dose of study drug.
Female subjects must agree to 1 of the following contraceptive methods:
Complete abstinence from intercourse of reproductive potential. True abstinence is an acceptable 
method of contraception only when it is in line with the subject’s preferred and usual lifestyle.
Or
Consistent and correct use of 1 of the following methods of birth control listed below:
•
Nonhormonal intrauterine device (IUD)
•
Hormonal IUD (must be used in conjunction with a barrier method)
•
Bilateral tubal occlusion (upon medical assessment of surgical success)
•
Vasectomy in the male partner (upon medical assessment of surgical success)
Or
Female subjects who wish to use a hormonally based method must use it in conjunction with a 
barrier method, preferably a male condom. Hormonal methods are restricted to those associated 
with the inhibition of ovulation. Hormonally based contraceptives and barrier methods permitted 
for use in this protocol are as follows:
•
Hormonal methods (each method must be used with a barrier method, preferably male 
condom)
a) Oral contraceptives (either combined or progesterone only) (see Appendix 17.6 for a list 
of UGT1A1 inducers and Section 7.6.)
b) Injectable progesterone
c) Subdermal contraceptive implant
d) Transdermal contraceptive patch
e) Contraceptive vaginal ring

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•
Barrier methods (each method must be used with a hormonal method)
a) Male condom (with or without spermicide)
b) Female condom (with or without spermicide)
c) Diaphragm with spermicide
d) Cervical cap with spermicide
e) Sponge with spermicide
Inclusion of methods of contraception in this list of permitted methods does not imply that the 
method is approved in any country or region. Methods should only be used if locally approved.
Female subjects must also refrain from egg donation, cryopreservation of germ cells, and in vitro 
fertilization during treatment and until the end of contraception requirement. Female subjects 
should be advised to seek advice of the Investigator about egg donation and cryopreservation of 
germ cells before treatment.
3)
Contraception Requirements for Patients Assigned Male at Birth
It is theoretically possible that a relevant systemic concentration of study drug may be achieved 
in a female partner from exposure of the male patient’s seminal fluid and poses a potential risk to 
an embryo/fetus. Therefore, male patients with female partners of childbearing potential must 
use condoms during treatment and until 3 months after the last dose of study drug. If the female 
partner of childbearing potential is not pregnant, additional highly effective contraception 
recommendations should also be considered.
Male patients must also refrain from sperm donation, and/or cryopreservation of germ cells 
during treatment and until the end of contraception requirement. Male patients should be advised 
to seek advice of the Investigator about sperm donation and cryopreservation of germ cells 
before treatment.
4)
Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, postovulation methods), declaration of abstinence for the duration of exposure to 
investigational medicinal product, withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.

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5)
Procedures to Be Followed in the Event of Pregnancy
Patients assigned female at birth will be instructed to notify the Investigator if they become 
pregnant or suspect they are pregnant at any time from start of the study and throughout the 
study (including the post study drug follow-up period) or 6 months after the last dose of study 
drug, whichever is longer. Study drug must be discontinued immediately upon consultation with 
the medical monitor.
Patients assigned female at birth whose partner has become pregnant or suspects she is pregnant 
from start of study and throughout the study (including the post study drug follow-up period) or 
3 months after the last study drug dose, whichever is longer, must also report the information to 
the Investigator. Instructions for reporting pregnancy, partner pregnancy, and pregnancy 
outcome are outlined in Section 10.2.4.

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17.6.
UGT1A1 Inhibitors and Inducers
Inducers of UGT1A1
Inhibitors of UGT1A1
Carbamazepine
Efavirenz
Ethinylestradiol
Lamotrigine
Phenobarbital
Phenytoin
Primidone
Rifampicin
Ritonavir
Tipranavir
Amitriptyline
Atazanavir
Dacomitinib
Dasabuvir
Deferasirox
Eltrombopag
Enasidenib
Erlotinib
Flunitrazepam
Flurbiprofen
Fostamatinib
Gemfibrozil
Glecaprevir
Indinavir
Indomethacin
Ketoconazole
Nilotinib
Ombitasvir
Paritaprevir
Pazopanib
Pexidartinib
Pibrentasvir
Probenecid
Propofol
Regorafenib
Rucaparib
Silibinin
Sorafenib
Valproic acid
UGT1A1 = uridine diphosphate glucuronosyltransferase 1A1

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17.7.
Disaster and Public Health Emergency Risk Assessment and Mitigation Plan
During an ongoing disaster or public health emergency (hereafter referred to as an event), 
potential risks associated with subjects being unable to attend study visits have been identified 
for this study.
These risks can be summarized as follows:
1) Study drug supplies
a) Subjects may be unable to return to the site for a number of visits to get the study drug, or 
the site may be unable to accept any subject visits. Without study drugs, the subject 
would not be able to continue their study treatment as planned per protocol.
Mitigation plan: At the earliest opportunity, the site will schedule in-person subject visits 
and return to the regular protocol schedule of procedures.
b) Shipments of study drug could be delayed because of transportation issues. Without study 
drug, enrolled subjects would not be able to continue receiving the study drug as planned 
per protocol.
Mitigation plan: The site’s study drug inventory should be closely monitored. Site staff 
should notify the Sponsor or delegate if they foresee shortage in study drug inventory or 
if there is any interruption in local shipping service. The Sponsor will continue to monitor 
inventory at the study drug depot and investigational sites. Manual shipments will be 
triggered as necessary.
2) Subject safety monitoring and follow-up:
a) Subjects may be unable or unwilling to come to the investigational site for their 
scheduled study visits as required per protocol.
Mitigation plan: For subjects who may be unable or unwilling to visit the investigational 
site for their scheduled study visits as required per protocol, the principal Investigator or 
qualified delegate will conduct a remote study visit, via phone or video conferencing, to 
assess the subject within the target visit window date whenever possible. During the 
remote study visit, the following information at minimum will be reviewed:
i) Confirm if subject has experienced any adverse events (AEs)/serious adverse events 
(SAEs)/special situations (including pregnancy) and follow up on any unresolved 
AEs/SAEs.
ii) Review the current list of concomitant medications and document any new 
concomitant medications.
iii) If applicable, confirm electronic diary questionnaires and patient-reported outcomes 
have been completed and transmitted.

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b) Subjects may be unable or unwilling to travel to the site for planned assessments 
(eg, safety blood draws); hence samples may not be sent for central laboratory analyses.
Mitigation plan: Local laboratories or other vendors may be used as appropriate to 
monitor subject safety until the subject can return to the site for their regular follow-up 
per protocol. Any changes in the party conducting laboratory assessments for the study 
due to the event will be documented accordingly. Pregnancy testing may be performed 
using a home urine pregnancy test if local laboratory pregnancy testing is not feasible.
c) Subjects may be unable or unwilling to attend the study visit to sign an updated informed 
consent form version.
Mitigation plan: The site staff will follow their approved consent process and remain in 
compliance with the local Ethics Committee/Institutional Review Board (EC/IRB) and 
national laws and regulations. Remote consent will be allowed if it has been approved by 
the local EC/IRB. The consent process will be documented and confirmed by normal 
consent procedure at the earliest opportunity.
d) The safety of study subjects is important and testing of coronavirus disease 2019 
(COVID-19) infection will be based on local clinical guidelines for testing based on 
signs/symptoms and/or suspected exposure to COVID-19.
Mitigation plan: If subject has a diagnosis of COVID-19 while on this clinical study, 
study drug may be held until clinical improvement or resolution in accordance with the 
treating physician’s judgment and general sacituzumab govitecan dose delay guidance in 
the protocol. Additional supportive care and treatment measures for COVID-19 infection 
on the study will be performed in accordance with local institutional guidelines. Subjects 
with a COVID-19 infection while participating in the clinical study will have this event 
documented as an AE in the clinical database.
3) Protocol and monitoring compliance:
a) Protocol deviations may occur in case scheduled visits cannot be conducted as planned 
per protocol.
Mitigation plan: If it is not possible to complete a required procedure, an unscheduled 
visit should be conducted as soon as possible when conditions allow. The situation should 
be recorded and explained as a protocol deviation. Any missed subject visits or deviation 
to the protocol due to the event must be reported in the eCRF and described in the clinical 
study report. Any remote study visits that are conducted in lieu of clinic visits due to the 
event will be documented as a protocol deviation.
b) Study monitors may be unable to carry out source data review or source data verification, 
or study drug accountability or assess protocol and Good Clinical Practice compliance. 
This may lead to delays in source data verification, an increase in protocol deviations, or 
underreporting of AEs.

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Mitigation plan: The study monitor is to remain in close communication with the site to 
ensure data entry and query resolution. Remote source data verification may be arranged 
if allowed by local regulation and the Study Monitoring Plan. The study monitor is to 
reference the Study Monitoring Plan for guidance on how to conduct an off-site 
monitoring visit. The study staff is to save and document all relevant communication in 
the study files. The status of sites that cannot accept monitoring visits and/or subjects 
on-site, must be tracked centrally and updated on a regular basis.
4) Missing data and data integrity:
a) There may be an increased amount of missing data due to subjects missing 
visits/assessments. This could have an impact on the analysis and the interpretation of 
clinical study data.
Mitigation plan: Implications of an event on methodological aspects for the study will be 
thoroughly assessed and documented, and relevant actions will be taken as appropriate 
(eg, modification of the statistical analysis plan) and in compliance with regulatory 
authorities’ guidance. Overall, the clinical study report will describe the impact of the 
event on the interpretability of study data.
5) Concurrent administration of the COVID-19 vaccine:
There may be potential safety issues due to concurrent administration of the COVID-19 
vaccine and study drugs.
Mitigation plan: There is not substantial safety data regarding the concurrent 
administration of the COVID-19 vaccine and sacituzumab govitecan. Subjects are 
allowed to receive the COVID-19 vaccine to reduce the risk and complications of 
COVID-19 infection. Investigators and study personnel should provide close surveillance 
of subjects after COVID-19 vaccine administration and the institutional guidelines should 
always be followed. The administration of specific COVID-19 vaccine must be 
documented in the clinical database and AEs associated with COVID-19 vaccine 
administration should be recorded in the AE eCRF. COVID-19 vaccine administration 
should be recorded in the prior or concomitant medication eCRF as appropriate. The 
study visits should continue as planned, if possible, and clinically appropriate if 
vaccination occurs while the subject is on the study.
Risks will be assessed continuously, and temporary measures will be implemented to mitigate 
these risks as part of a mitigation plan, as described above. These measures will be 
communicated to the relevant stakeholders as appropriate and are intended to provide alternate 
methods that will ensure the evaluation and assessment of the safety of subjects who are enrolled 
in this study.
Since these potential risks are considered mitigated with the implementation of these measures, 
the expected risk/benefit assessment of sacituzumab govitecan in study subjects remains 
unchanged.

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17.8.
Marketing Authorization Status of Study Interventions
Study Intervention 
Name
Category
Authorized in 
≥ 1 Country Following 
EU Regulation 
No. 536/2014
Authorized in ≥ 1 ICH 
Country
Sacituzumab govitecan
Study drug
Noa
Noa
Hydrocortisone
AxMP
Yes
Yes
Palonosetron
AxMP
Yes
Yes
Fosaprepitant
AxMP
Yes
Yes
Aprepitant
AxMP
Yes
Yes
Dexamethasone
AxMP
Yes
Yes
Olanzapine
AxMP
Yes
Yes
Loperamide
AxMP
Yes
Yes
Diphenoxylate
AxMP
Yes
Yes
Atropine
AxMP
Yes
Yes
Opium tincture
AxMP
Yes
Yes
Octreotide
AxMP
Yes
Yes
G-CSF
AxMP
Yes
Yes
AxMP = auxiliary medicinal product; EU = European Union, ICH = International Council for Harmonisation; 
G-CSF = granulocyte colony-stimulating factor; Requirements for Pharmaceuticals for Human Use
a.
Rationale described in Section 1.1.4

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17.9.
Risk Factors for Febrile Neutropenia
Subjects should be evaluated for risk factors of febrile neutropenia according to local guidelines 
or American Society of Clinical Oncology (ASCO)/European Society for Medical Oncology 
(ESMO)/National Comprehensive Cancer Network (NCCN) guidelines. Risk factors per ASCO 
guidelines are provided as an example below.
Patient Risk Factors for Febrile Neutropenia
Age > 65 years
Advanced disease
Previous chemotherapy or radiation therapy
Preexisting neutropenia or bone marrow involvement with tumor
Infection
Open wounds or recent surgery
Poor performance status or nutritional status
Poor renal function
Liver dysfunction, most notably elevated bilirubin
Cardiovascular disease
Multiple comorbid conditions
HIV infection
HIV = human immunodeficiency virus; ASCO = American Society of Clinical Oncology
Source: Patient characteristics associated with high risk for febrile neutropenia per ASCO guidelines {Smith 2015}

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17.10.
Country-Specific Requirements
Not applicable.

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17.11.
Amendment History
High-level summaries of the history of this study’s amendments are provided in tabular form in 
the subsections below (from most recent amendment to oldest). Minor changes such as the 
correction of typographic errors, grammar, or formatting are not detailed.
Separate summary of change documents for earlier amendments are available upon request.
A separate tracked change (red-lined) document comparing the previous version of the protocol 
to this amendment will be made available upon the publication of this protocol.
17.11.1.
Amendment 5 (17 December 2024)
Rationale for Key Changes Included in Amendment 5
Affected Sections
Updated European Union Clinical Trial (EU CT) number to comply with EU- 
Clinical Trials Regulation (CTR) requirements.
Title page
Updated to add information on study modifications after implementation of 
Protocol Amendment 5 (PA5). The modifications reduce the schedule of 
assessments for subjects remaining on treatment and terminate survival 
follow-up for subjects who have previously discontinued treatment.
Synopsis, Sections 3, 4, 5, and 
10.1.4
Information on survival follow-up for subjects was updated with procedures 
following implementation of PA5. 
Synopsis and Section 4.7
Information on end of study for subjects was updated with procedures 
following implementation of PA5.
Synopsis and Section 4.8
Updated text to align with the approval status of sacituzumab govitecan (SG) 
in the United States.
Sections 1.1.3 and 1.1.4
Updated safety recommendations for subjects who are at risk for 
complications from neutropenia.
Sections 1.1.3.3, 1.2.2, 7.5.1, 
7.5.2.3, and Appendix 17.9
Updated to expand pandemic risk and mitigation plan to disasters and public 
health emergencies to align with recent regulatory guidance.
Section 1.2.2 and 
Appendix 17.7
Added text to clarify that pharmacokinetic (PK), anti-drug antibody (ADA), 
biomarker samples, and uridine diphosphate-glucuronosyltransferase 1A1 
(UGT1A1) genotyping will not be collected following implementation of PA5. 
Added information for scans, tumour response data, and disease following 
implementation of PA5. 
Sections 4.3, 10.3, 10.4, 10.5, 
and 10.6
Table summarizing recommendations for SG dose reductions and 
discontinuations for treatment-related toxicities was added.
Section 7.5.2.5
Updated text to clarify that while tumor response data will no longer be 
collected after implementation of PA5, subjects who continue treatment will 
be expected to have scans performed per standard of care.
Sections 5 and 9
Text updated to align with adverse event and suspected unexpected serious 
adverse reaction (SUSAR) reporting requirements and procedures.
Sections 10.2.2.2, 10.2.5, and 
10.2.6
Added text to clarify that enterprise level technical and organizational controls 
have been developed at Gilead Sciences for the purpose of data protection.
Section 12.6

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Rationale for Key Changes Included in Amendment 5
Affected Sections
Updated text to clarify that a clinical study report (CSR) will be prepared and 
provided to the regulatory agency(ies) and study results will be made publicly 
available when applicable and in accordance with local regulatory 
requirements.
Section 15
Minor clarifications and changes to correct typographic errors.
Throughout, as needed
17.11.2.
Amendment 4 (09 October 2023 )
Rationale for Key Changes Included in Amendment 4
Affected Sections
A statement to clarify that the hematology and serum chemistry tests may be 
performed and reviewed up to 24 hours prior to scheduled study treatment 
administration was added
Section 4.3, Section 5 
(Table 2: footnotes ‘j’ and 
‘l’)
Text was updated to align with SG content library
Section 8.5
Changes from administrative amendment 3.0.1 were added to the protocol
Sections 4.6 and 7.5.2.5
Changes from administrative amendment 3.0.2 were added to the protocol
Sections 4.3, 5, (Table 2: 
footnote ‘t’), 8.3, 8.4, and 
10.2.2.1
A separate page for the Sponsor Signature Page was added to the appendices to 
align with Clinical Trials Information System (CTIS) requirements for a 
consolidated and harmonized protocol
Appendix 17.11
A separate page for Amendment History and Country-Specific Requirement was 
added to align with EU CTR requirement
Appendix 17.9 and 17.10
A separate page for Marketing Authorization Status of Study Interventions was 
added to align with EU CTR requirement
Appendix 17.8
Minor changes to correct typographic errors
Throughout, as needed

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17.12.
Sponsor Signature Page
GILEAD SCIENCES, INC.
333 LAKESIDE DRIVE
FOSTER CITY, CA 94404
STUDY ACKNOWLEDGMENT
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with 
Metastatic Solid Tumors IMMU-132-11, Protocol Amendment 5, 17 December 2024
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval.
[See appended electronic signature]
Name (Printed)
Associate Director, Clinical 
Development
Signature
[See appended electronic signature]
Date
PPD

Prot_IMMU-132-11_amd-5
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
18-Dec-2024
16:21:00
PPD