Open-label Rollover Study to Evaluate Long-Term Safety in Subjects With Metastatic Solid Tumors That Are Benefiting From Continuation of Therapy With Sacituzumab Govitecan
Phase: PHASE4
Conditions: Metastatic Solid Tumors
Sponsor: Gilead Sciences

  
CLINICAL STUDY PROTOCOL
Study Title:
Open-label Rollover Study to Evaluate Long-Term Safety in Subjects 
with Metastatic Solid Tumors that are Benefiting from Continuation of 
Therapy with Sacituzumab Govitecan
Sponsor:
Gilead Sciences, Inc.
(Immunomedics, Inc. is now part of the Gilead group of companies)
333 Lakeside Drive
Foster City, CA 94404
USA
IND Number:
115621
EudraCT Number:
2019-004868-22
ClinicalTrials.gov 
Identifier:
NCT04319198
Indication:
Metastatic solid tumors
Protocol ID:
IMMU-132-14
Contact Information:
The medical monitor name and contact information will be provided on 
the Key Study Team Contact List.
Protocol Version/Date:
Original:
16 December 2019 
Amendment 1:
27 August 2021
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 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.
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The information contained in this document, particularly unpublished data, is the property or under 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.
GILEAU 

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Protocol IMMU-132-14
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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
(Immunomedics, Inc. is now part of the Gilead group of companies)
333 Lakeside Drive
Foster City, CA 94404
Name of Sponsor/Company: Gilead Sciences, Inc.
(Immunomedics, Inc. is now part of the Gilead group of companies)
Name of Investigational Product: Sacituzumab govitecan
Name of Active Ingredient: Sacituzumab govitecan is an antibody-drug conjugate composed 
of hRS7, a humanized IgG1κ monoclonal antibody (mAb) that binds to trophoblast cell-
surface antigen-2 (Trop-2); SN-38, a camptothecin analog that inhibits topoisomerase I; and 
CL2A, a pH-sensitive linker that couples SN-38 to hRS7.
Protocol Number: IMMU-132-14
Rollover Study 
Country: United States (US), Europe, 
and rest of the world countries
Title of Study: Open-label Rollover Study to Evaluate Long-Term Safety in Subjects with 
Metastatic Solid Tumors That are Benefiting from Continuation of Therapy with Sacituzumab 
Govitecan 
Primary Objective: Evaluate long-term safety in subjects with metastatic solid tumors that 
are benefiting from continuation of therapy with sacituzumab govitecan
Study Design: This is a Phase 4, open-label, longitudinal cohort, rollover study designed to 
evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from 
continuation of therapy with sacituzumab govitecan. Only subjects who continue to receive 
clinical benefit from continuation of sacituzumab govitecan therapy and are tolerating therapy 
at the time of enrollment are eligible for this study. Subjects enrolled may continue to receive 
sacituzumab govitecan at the dose that they were receiving in the Gilead (previously 
Immunomedics)-sponsored parent study at the time of consenting to participate in this rollover 
study. No dose escalation beyond the dose the subject was receiving in the parent study at the 
time of consenting to participate in this rollover study is permitted. Subjects who continued to 
receive sacituzumab govitecan in a parent study after disease progression (PD) may continue 
to receive sacituzumab govitecan in this rollover study. No subject will receive more than 
10 mg/kg dose of sacituzumab govitecan in this rollover study. Subjects may continue to 
receive sacituzumab govitecan until they experience toxicity, disease progression with no 
evidence of clinical benefit, loss of clinical benefit, withdrawal of consent, lost to follow-up, 
or sponsor termination of the study is documented. Subjects of childbearing potential will be 
followed for Safety Follow-up after study drug discontinuation. Subjects with ongoing adverse 
events (AEs) or serious adverse events (SAEs) will be followed for Safety Follow-up after 
EOT.

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Number of subjects (planned): Up to approximately 200
Diagnosis and main criteria for inclusion:
Subjects meeting all the following inclusion criteria at Screening/Day -1 of treatment will be 
eligible for participation in the study.
1) Female or male subjects, ≥18 years of age, able to understand and give written informed 
consent
2) Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously 
Immunomedics)-sponsored parent study
3) Continuing to receive clinical benefit from sacituzumab govitecan therapy
4) Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation
5) 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 4.
Main criteria for exclusion:
Subjects meeting any of the following exclusion criteria at Screening/Day -1 of treatment will 
not be enrolled in the study.
1) Women who are pregnant or lactating (Appendix 4)
2) Initiated therapy with another cancer therapeutic agent (investigational or standard of care) 
since receiving the last dose of the study drug on the parent study in which they 
participated
3) Experienced a toxicity from sacituzumab govitecan that resulted in permanent 
discontinuation of therapy
4) Have an active serious infection requiring IV antibiotics (Contact medical monitor for 
clarification)
5) 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
Investigational product, dosage and mode of administration: Sacituzumab govitecan will 
be administered at the dose that the subject was receiving in the parent study at the time of 
consenting to participate in this rollover study. No dose escalation beyond the dose the subject 
was receiving in the parent study at the time of consenting to participate in this rollover study 
is permitted. No subject will receive more than 10 mg/kg dose of sacituzumab govitecan. 
Sacituzumab govitecan will be administered as an intravenous (IV) infusion on Days 1 and 8 
of a 21-day cycle.

Sacituzumab Govitecan 
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Gilead Sciences, Inc. (Immunomedics, Inc. is now part of the Gilead group of companies) 
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Amendment 1 
Duration of treatment: Sacituzumab govitecan will be administered as an IV infusion on 
Days 1 and 8 of a 21-day cycle until PD, toxicity or withdrawal of consent, lost to follow-up 
or loss of clinical benefit, or sponsor tennination of the study is documented. Treatment 
beyond PD is pennitted ifthere is evidence of clinical benefit per treating physician's 
assessment. 
Criteria for evaluation: 
Efficacy: Efficacy will not be assessed in this study. 
Safety: Long-te1m safety will be evaluated based on AEs and SAEs noted with continued 
therapy. 
Statistical methods: 
Long-te1m safety will be evaluated based on AEs and SAEs noted with continued therapy, 
standard safety laboratories, study dmg exposure, and conc01nitant medications. Descriptive 
analyses of the safety data will be perfo1med. 
These analyses will be presented by cancer type and histology when deemed appropriate and 
by the overall study population 
This study will be conducted in accordance with the guidelines of Good Clinical Practice, 
including archiving of essential documents. 
CONFIDENTIAL 
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TABLE OF CONTENTS
PROTOCOL SYNOPSIS................................................................................................................................................2
TABLE OF CONTENTS................................................................................................................................................5
LIST OF IN-TEXT TABLES .........................................................................................................................................7
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS.................................................................................8
1.
INTRODUCTION..................................................................................................................................................9
1.1.
Mechanism of Action of Sacituzumab Govitecan.....................................................................................9
1.2.
Nonclinical Experience .............................................................................................................................9
1.2.1.
Pharmacology..........................................................................................................................9
1.2.2.
Toxicology...............................................................................................................................9
1.3.
Clinical Experience .................................................................................................................................10
1.3.1.
Pharmacokinetics...................................................................................................................10
1.3.2.
Immunogenicity.....................................................................................................................11
1.3.3.
Rationale for Dose Regimen .................................................................................................11
1.3.4.
Summary of Sacituzumab Govitecan Safety.........................................................................12
2.
STUDY OBJECTIVES AND PURPOSE............................................................................................................13
2.1.
Primary Objective....................................................................................................................................13
3.
INVESTIGATIONAL PLAN ..............................................................................................................................14
3.1.
Overall Study Design ..............................................................................................................................14
3.2.
Number of Subjects .................................................................................................................................14
3.3.
Treatment Assignment.............................................................................................................................14
3.4.
End of Treatment.....................................................................................................................................14
3.5.
Safety Follow-Up ....................................................................................................................................14
3.6.
End of Study............................................................................................................................................15
4.
PROCEDURES....................................................................................................................................................16
4.1.
Informed Consent ....................................................................................................................................16
4.2.
Screening .................................................................................................................................................16
4.2.1.
Screen Failures ......................................................................................................................16
4.3.
Study Procedures.....................................................................................................................................16
5.
SELECTION AND WITHDRAWAL OF SUBJECTS .......................................................................................19
5.1.
Subject Inclusion Criteria........................................................................................................................19
5.2.
Subject Exclusion Criteria.......................................................................................................................19
5.3.
Criteria for Treatment Discontinuation ...................................................................................................20
5.4.
Criteria for Study Discontinuation ..........................................................................................................20
6.
TREATMENT OF SUBJECTS............................................................................................................................21
6.1.
Description of Study Drug.......................................................................................................................21
6.2.
Investigational Medicinal Product, Dosage and Mode of Administration..............................................21
6.3.
Treatment of Sacituzumab Govitecan-Associated Toxicities .................................................................21
6.3.1.
Preventative Medications ......................................................................................................21
6.3.2.
Management of Sacituzumab Govitecan Toxicities..............................................................22
6.4.
Concomitant Medications........................................................................................................................26
6.5.
Drug Interactions.....................................................................................................................................26
6.5.1.
UGT1A1 Inhibitors ...............................................................................................................27
6.5.2.
UGT1A1 Inducers .................................................................................................................27
6.6.
Treatment Compliance ............................................................................................................................27

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7.
STUDY DRUG MATERIALS AND MANAGEMENT.....................................................................................28
7.1.
Study Drug...............................................................................................................................................28
7.2.
Study Drug Packaging and Labeling.......................................................................................................28
7.3.
Study Drug Storage .................................................................................................................................28
7.4.
Study Drug Preparation ...........................................................................................................................28
7.5.
Administration.........................................................................................................................................28
7.6.
Study Drug Accountability......................................................................................................................29
7.7.
Study Drug Handling and Disposal.........................................................................................................29
7.7.1.
Study Drug Shipment ............................................................................................................29
7.7.2.
Receipt of IMP ......................................................................................................................29
7.7.3.
Study Drug Disposal..............................................................................................................30
8.
ASSESSMENT OF EFFICACY..........................................................................................................................31
9.
OTHER EVALUATIONS....................................................................................................................................32
10.
ASSESSMENT OF SAFETY ..............................................................................................................................33
10.1.
Safety Parameters ....................................................................................................................................33
10.1.1.
Weight ...................................................................................................................................33
10.1.2.
Laboratory Assessments........................................................................................................33
10.2.
Adverse Event Reporting ........................................................................................................................34
10.2.1.
Safety Reporting Definitions.................................................................................................34
10.2.2.
Adverse Event and Special Situation Reporting ...................................................................36
10.2.3.
Reporting Deaths...................................................................................................................40
10.2.4.
Pregnancy Reporting Process................................................................................................40
10.2.5.
Investigator Immediate Reporting Requirements..................................................................41
10.2.6.
Investigator Notification to Local Institutional Review Boards/Ethics 
Committees............................................................................................................................42
10.2.7.
Sponsor Responsibilities .......................................................................................................42
11.
STATISTICS........................................................................................................................................................43
11.1.
Sample Size Determination .....................................................................................................................43
11.2.
Populations for Analyses.........................................................................................................................43
11.3.
Statistical Analyses..................................................................................................................................43
11.3.1.
Endpoints...............................................................................................................................43
11.3.2.
Efficacy Analyses..................................................................................................................43
11.3.3.
Safety Analyses .....................................................................................................................43
12.
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ..................................................................................44
12.1.
Study Monitoring.....................................................................................................................................44
12.2.
Audits and Inspections ............................................................................................................................44
12.3.
Institutional Review Board /Independent Ethics Committee ..................................................................44
13.
QUALITY CONTROL AND QUALITY ASSURANCE ...................................................................................45
14.
ETHICS................................................................................................................................................................46
14.1.
Ethics Review..........................................................................................................................................46
14.2.
Ethical Conduct of the Study...................................................................................................................46
14.3.
Written Informed Consent.......................................................................................................................47
14.4.
Good Clinical Practice.............................................................................................................................47
14.5.
Protocol Compliance ...............................................................................................................................47
14.6.
Subject Data Protection ...........................................................................................................................48
14.7.
Financial Disclosure ................................................................................................................................48
14.8.
Sponsor Discontinuation Criteria ............................................................................................................49

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15.
DATA HANDLING AND RECORDKEEPING.................................................................................................50
15.1.
Inspection of Records..............................................................................................................................50
15.2.
Retention of Records ...............................................................................................................................50
15.3.
Electronic Case Report Forms.................................................................................................................50
16.
PUBLICATION POLICY....................................................................................................................................51
17.
LIST OF REFERENCES .....................................................................................................................................52
18.
APPENDICES......................................................................................................................................................53
LIST OF IN-TEXT TABLES
Table 1.
Schedule of Assessments.........................................................................................................17
Table 2.
Recommended Dose Modification Schedule for Sacituzumab Govitecan..............................25
Table 3.
Grading for Adverse Events Not Listed in NCI-CTCAE........................................................38

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
The following abbreviations are used in this study protocol.
AE
adverse event
ANC
absolute neutrophil count
BUN
blood urea nitrogen
CFR
Code of Federal Regulation
CTCAE
Common Terminology Criteria for Adverse Events
eCRF
electronic case report form
EOS
end of study
EOT
end of treatment
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act of 1996
hRS7
humanized RS7 anti-Trop-2 immunoglobulin G
ICH
International Council for Harmonisation of Technical Requirements for Pharmaceuticals 
for Human Use
IEC
independent ethics committee
IMMU-132
company code for sacituzumab govitecan
IMP
investigational medicinal product
IND
investigational new drug
IRB
institutional review board
IRR
infusion-related reaction
IWRS
interactive web response system
mAb
monoclonal antibody
MTD
maximum tolerated dose
mTNBC
metastatic triple-negative breast cancer
NCI
National Cancer Institute
NSCLC
non–small-cell lung cancer 
PD
progressive disease/disease progression
SAE
serious adverse event
TNBC
triple-negative breast cancer
Trop-2
trophoblastic cell-surface antigen 2
UGT1A1
uridine diphosphate glucuronosyltransferase 1A1
US
United States (of America)

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1.
INTRODUCTION
1.1.
Mechanism of Action of Sacituzumab Govitecan
Sacituzumab govitecan (company code: IMMU-132) is a trophoblast cell-surface antigen-2 
(Trop-2)-directed antibody-drug conjugate that comprises SN-38, a topoisomerase I inhibitor and 
active metabolite of irinotecan, coupled by a linker (CL2A) to the humanized monoclonal 
antibody (mAb) hRS7 immunoglobulin G1 (IgG1)κ, which binds to Trop-2. Trop-2 is a 
transmembrane calcium signal transducer glycoprotein of the Tumor Associated Calcium Signal 
Transducer 2 (TACSTD2) gene family. Pharmacology data suggest that sacituzumab govitecan 
binds to Trop-2-expressing cancer cells and is internalized with the subsequent release of SN-38 
via hydrolysis of the linker. SN-38 interacts with topoisomerase I and prevents re-ligation of 
topoisomerase I-induced single strand breaks. The resulting DNA damage leads to apoptosis and 
cell death. The hydrolysable linker may permit release of SN-38 in the acidic microenvironment 
of the tumor without Trop-2 binding.
1.2.
Nonclinical Experience
1.2.1.
Pharmacology
Sacituzumab govitecan has been evaluated for in vitro cytotoxicity and in vivo efficacy in a 
variety of human solid tumor types, including prostate, non–small-cell lung cancer (NSCLC), 
colon, pancreatic, squamous cell lung, gastric, and triple-negative breast cancer (TNBC) 
{Cardillo 2015, Cardillo 2011, Cardillo 2017, Goldenberg 2015}. In general, IC50 values ranged 
from 1 to 83 nM across various disease indications {Cardillo 2011, Cardillo 2017, Goldenberg 
2015}. In vivo, significant anti-tumor effects mediated by sacituzumab govitecan therapy were 
noted in tumor xenograft disease models of TNBC, NSCLC, colon, pancreatic, gastric, and 
squamous cell lung.
Additional information regarding nonclinical pharmacology of sacituzumab govitecan can be 
found in the current edition of the investigator’s brochure.
1.2.2.
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 1500 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 that returned to normal by the end of 
the study.
In cynomolgus monkeys, sacituzumab govitecan administered 50 mg/kg/dose (human equivalent 
dose [HED] = 16 mg/kg/dose) for four treatment cycles (Days 1 and 8 of a 21-day cycle) was 
considered a no observed 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 

Sacit uz u ma b G o viteca n
Pr ot oc ol I M M U- 1 3 2- 1 4
Fi nal
Gilea d Scie nces, I nc. (I m m u n o me dics, I nc. is n o w part of t he Gilea d gr o u p of c o m pa nies)
A me n d me nt 1
C O N FI D E N TI A L
Pa ge 1 0
2 7 A u g ust 2 0 2 1
( hair l oss, pi g me ntati o n), ki d ne y ( periarteritis), l y m p h oi d or ga ns (l y m p h oi d de pleti o n), b o ne 
marr o w (re d uce d cell ularit y) wit h c o nc o mita nt re d ucti o ns i n re d cells, w hite cells a n d platelets 
a n d t he gastr oi ntesti nal tract ( necr osis, er osi o ns, i nfla m mati o n, fi br osis, he m orr ha ge, e de ma).
S N- 3 8 was ne gati ve f or m uta ge nicit y i n a bacterial re verse m utati o n test a n d was f o u n d t o be 
clast o ge nic i n a n i n vitr o ma m malia n cell micr o n ucle us test. Neit her t he carci n o ge nicit y, n or 
effects of sacit uz u ma b g o viteca n o n fertilit y, earl y e m br y o nic de vel o p me nt or pre- a n d p ost- natal 
de vel o p me nt ha ve bee n assesse d. H o we ver, S N- 3 8 is a ca m pt ot heci n a n d he nce is li kel y 
carci n o ge nic. F urt her m ore, S N- 3 8 is a k n o w n de vel o p me ntal t o xica nt.
A d diti o nal i nf or mati o n re gar di n g n o ncli nical t o xic ol o g y of sacit uz u ma b g o viteca n ca n be f o u n d 
i n t he c urre nt e diti o n of t he i n vesti gat or’s br oc h ure.
1. 3.  
Cli nic al E x perie nce
Sacit uz u ma b g o viteca n recei ve d accelerate d a p pr o val i n t he U S f or use i n metastatic T N B C 
( m T N B C) base d o n res ults fr o m t he P hase 1/ 2 St u d y I M M U- 1 3 2- 0 1, a n d s u bse q ue ntl y recei ve d 
f ull a p pr o val base d o n res ults fr o m t he P hase 3 c o nfir mat or y St u d y I M M U- 1 3 2- 0 5. Sacit uz u ma b 
g o viteca n recei ve d accelerate d a p pr o val f or use i n metastatic ur ot helial ca ncer ( m U C) base d o n 
res ults fr o m t he P hase 2 St u d y I M M U- 1 3 2- 0 6 a n d is c urre ntl y bei n g st u die d i n s u bjects wit h 
m U C i n t he c o nfir mat or y St u d y I M M U- 1 3 2- 1 3. Sacit uz u ma b g o viteca n is als o c urre ntl y bei n g 
st u die d i n metastatic breast ca ncer (I M M U- 1 3 2- 0 9) a n d vari o us e pit helial ca ncers 
(I M M U- 1 3 2- 1 1). 
T he lar gest e x perie nce t o d ate is a P hase 1/ 2 st u d y (I M M U- 1 3 2- 0 1) title d “ P hase 1/ 2 St u d y of 
I M M U- 1 3 2 ( h R S 7- S N 3 8 A nti b o d y Dr u g C o nj u gate) i n E pit helial Ca ncers.” Fi ve h u n dre d t we nt y 
s u bjects were e nr olle d i n t his st u d y re gar dless of Tr o p- 2 e x pressi o n a n d were treate d wit h 
sacit uz u ma b g o viteca n m o n ot hera p y. D os es of 8 t o 1 8 m g/ k g were teste d wit h t he 1 0- m g/ k g 
d ose selecte d f or f urt her i n vesti gati o n.
A d diti o nal i nf or mati o n re gar di n g cli nical st u dies ca n be f o u n d i n t he c urre nt e diti o n of t he 
i n vesti gat or’s br oc h ure.
1. 3. 1. 
P h ar m ac o ki netics
1. 3. 1. 1. 
P har mac o ki netics
T he ser u m p har mac o ki netics ( P K) of sacit uz u ma b g o viteca n a n d free S N- 3 8 were e v al uate d i n a 
P hase 3 St u d y I M M U- 1 3 2- 0 5 i n a p o p ulati o n of m T N B C s u bjects w h o recei v e d sacit uz u ma b 
g o viteca n as a si n gle a ge nt at a d os e of 1 0 m g/ k g. Sacit uz u ma b g o viteca n a n d free S N- 3 8 ha d a 
C ma x  perce nta ge c oefficie nt of variati o n ( % C V) of 2 4 0, 0 0 0 n g/ m L ( 2 2. 2 %) a n d 9 0. 6 n g/ m L 
( 6 5 %) res pecti vel y, a n d A U C0- 1 6 8 ( % C V) of 5, 3 4 0, 0 0 0 h ⸱n g/ m L ( 2 3. 7 %) a n d 2, 7 3 0 h ⸱n g/ m L 
( 4 1. 1 %), res pecti vel y.
A d diti o nal i nf or mati o n re gar di n g P K p ara meters of sacit uz u ma b g o viteca n ca n be f o u n d i n t he 
c urre nt e diti o n of t he i n vesti gat or’s br oc h ure.

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1.3.1.2.
Distribution
Based on population PK analysis, central volume of distribution of sacituzumab govitecan is 
2.96 L.
1.3.1.3.
Elimination
The mean half-life of sacituzumab govitecan and free SN-38 was 15.3 and 19.7 hours, 
respectively. Based on population PK analysis, the clearance of the sacituzumab govitecan is 
0.14 L/h.
1.3.1.4.
Metabolism
No metabolism studies with sacituzumab govitecan have been conducted. SN-38 (the small 
molecule moiety of sacituzumab govitecan) is metabolized via uridine diphosphate 
glucuronosyltransferase 1A1 (UGT1A1). SN-38 glucuronide (SN-38G) was detectable in the 
serum of subjects.
1.3.1.5.
Excretion
SN-38 and SN-38G have been reported to be mainly eliminated via biliary excretion.
1.3.2.
Immunogenicity
As with all therapeutic proteins, there is potential for an immune response to sacituzumab 
govitecan. None of the subjects with treatment-emergent adverse events (TEAEs) and subjects 
who were confirmed antidrug antibody (ADA) positive had infusion reactions or adverse events 
(AEs) suggestive of immunogenicity.
1.3.3.
Rationale for Dose Regimen
The total body clearance (CL) of sacituzumab govitecan is mediated by both catabolism of the 
antibody and metabolism of the released payload, SN-38. The distribution and CL of the 
antibody portion of sacituzumab govitecan are likely to be similar to those other IgG1 antibodies 
and are influenced by target (Trop-2)-mediated uptake on antigen-expressing cells, pinocytosis, 
and neonatal Fc receptor negative-mediated CL mechanisms in vivo. SN-38 is primarily 
eliminated from the body via the hepatic route. 
In the Phase 1 part of Study IMMU-132-01, dose escalation was performed with doses ranging 
from 8 to 18 mg/kg. A sacituzumab govitecan dose of 12 mg/kg was formally identified as the 
maximum tolerated dose (MTD) but was associated with dose delays and reductions in several 
subjects. A sacituzumab govitecan dose of 10 mg/kg was found to be safe and efficacious and is 
the recommended starting dose for subjects with normal hepatic function and mild hepatic 
impairment. Additional information regarding the safety and efficacy of sacituzumab govitecan 
can be found in the investigator’s brochure. 

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In this study, sacituzumab govitecan will be administered at the dose the subject was receiving in 
the Gilead (previously Immunomedics)-sponsored parent study at the time of consenting to 
participate in this rollover study. No dose escalation beyond the dose the subject was receiving in 
the parent study at the time of consenting to participate in this rollover study is permitted. 
Sacituzumab govitecan will be administered as an IV infusion on Days 1 and 8 of a 21-day cycle 
until PD, toxicity or withdrawal of consent, lost to follow-up, loss of clinical benefit, or sponsor 
termination of the study is documented. Treatment beyond PD is permitted if there is evidence of 
clinical benefit per treating physician’s assessment. This rollover study will provide these 
subjects an opportunity for continuation of therapy.
1.3.4.
Summary of Sacituzumab Govitecan Safety
The safety profile for sacituzumab govitecan was similar in the treatment of mTNBC and mUC. 
The most common AEs were nausea, diarrhea, neutropenia, fatigue, alopecia, anemia, vomiting, 
and constipation. The most clinically relevant Grade 3 or Grade 4 AEs with sacituzumab 
govitecan were neutropenia and diarrhea. The most frequent AEs that led to treatment 
modification were neutropenia and diarrhea. The frequent AEs leading to permanent 
discontinuation of sacituzumab govitecan were fatigue, diarrhea, pneumonia, and neutropenia.
Neutropenia 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. 
Diarrhea with sacituzumab govitecan 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. 
Higher incidences of neutropenia, febrile neutropenia, and anemia were seen in subjects who 
were homozygous for the UGT1A1*28 allele compared with subjects who were heterozygous for 
the UGT1A1*28 allele and subjects who were homozygous for the wild-type allele.
For further information on sacituzumab govitecan, refer to the current investigator’s brochure.

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2.
STUDY OBJECTIVES AND PURPOSE
2.1.
Primary Objective
Evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from 
continuation of therapy with sacituzumab govitecan.

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3.
INVESTIGATIONAL PLAN
3.1.
Overall Study Design
This is a Phase 4, open-label, longitudinal cohort, rollover study designed to evaluate long-term 
safety in subjects with metastatic solid tumors that are benefiting from continuation of therapy 
with sacituzumab govitecan. Only subjects who continue to receive clinical benefit from 
continuation of sacituzumab govitecan therapy and are tolerating therapy at the time of 
enrollment are eligible for this study. Subjects enrolled may continue to receive sacituzumab 
govitecan at the dose that they were receiving in the parent study at the time of consenting to 
participate in this rollover study. No dose escalation beyond the dose the subject was receiving in 
the parent study at the time of consenting to participate in this rollover study is permitted. 
Subjects who continued to receive sacituzumab govitecan in a parent study after disease 
progression (PD) may continue to receive sacituzumab govitecan in this rollover study. No 
subject will receive more than 10 mg/kg dose of sacituzumab govitecan in this rollover study. 
Subjects may continue to receive sacituzumab govitecan until they experience toxicity, disease 
progression with no evidence of clinical benefit, loss of clinical benefit, withdrawal of consent, 
lost to follow-up, or sponsor termination of the study is documented. Subjects of childbearing 
potential will be followed for Safety Follow-up after study drug discontinuation. Subjects with 
ongoing adverse events (AEs) or serious adverse events (SAEs) will be followed for Safety 
Follow-up after EOT.
3.2.
Number of Subjects
Up to approximately 200 subjects may be enrolled. Only subjects currently receiving 
sacituzumab govitecan in a parent study are permitted.
3.3.
Treatment Assignment
This is a non-randomized, open-label, longitudinal cohort, rollover study.
3.4.
End of Treatment
After discontinuation of treatment (See Section 5.3), all subjects must complete an end of 
treatment (EOT) visit approximately 30 days after the last dose of the study drug. Data should be 
entered into the EOT electronic case report form (eCRF).
3.5.
Safety Follow-Up
After the EOT visit, subjects of childbearing potential and subjects who have ongoing AEs or 
SAEs will be followed in Safety Follow-up according to the Schedule of Assessments (Table 1), 
unless the subject explicitly indicates their desire to forego Safety Follow-up in writing to their 
study investigator. The Safety Follow-up visits may be completed by telephone unless a 
confirmatory serum pregnancy test is required as outlined in the Schedule of Assessments 
(Table 1).

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3.6.
End of Study
The end of the study will be the date of the last visit/contact/follow-up in the study. An End of 
Study (EOS) visit must be performed and entered into the EOS eCRF if the criteria cited in 
Section 5.4 have been met. The EOS visit can be performed by telephone.

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4.
PROCEDURES
4.1.
Informed Consent
No study-specific procedure or alteration of subject care will be undertaken until informed 
consent has been obtained from the subject or legal representative. The Investigator will explain 
the nature and scope of the study, potential risks and benefits of participation and answer all 
questions for the subject and/or legally authorized representative. Subjects must be informed of 
available alternative treatment options prior to consenting to participate in this study.
If the subject agrees to participate, the informed consent form 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
Subjects must complete all screening procedures after signing the informed consent form. 
Absolutely no waivers for subject eligibility will be offered or permitted.
Subjects are permitted to rescreen only once for the study.
4.2.1.
Screen Failures
Subjects who are consented to participate in the clinical study, and who do not meet one or more 
criteria required for participation in the study during the screening visit, are considered screen 
failures. All subjects who have signed informed consent and were deemed ineligible will be 
recorded with the reason for ineligibility on the appropriate eCRF. 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, study discontinuation date, 
adverse events and any SAE.
4.3.
Study Procedures
Enrollment occurs upon completion of all screening procedures. Enrollment will be performed 
centrally by an interactive web response system (IWRS). Clear documentation as to the reason 
the subject was not dosed should be provided on the relevant eCRF. Unless otherwise specified, 
collection windows for laboratory assessments prior to dosing may be obtained up to 3 days prior 
to dosing. Treatment (dosing) may be permitted either 1 day before or within 7 days after 
scheduled visits.
An infectious disease pandemic may pose additional risks to study drug availability, the study 
visit schedule, and adherence to protocol-specified safety monitoring or laboratory assessments. 
Refer to Appendix 2 for further details on the risks and risk mitigation strategy.
For safety parameters, please refer to Section 10.1.

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Table 1.
Schedule of Assessments
Phase
Pre-
Treatment
Treatment
Period
Screening
Treatment Cycle 1 through Last 
Cycle
(21-day cycle)
Day
Days −21 to 1
Day 1 (includes baseline 
C1D1)
Day 8
Unscheduled 
Visit
End of 
Treatmenta
Safety Follow-
upb
End of 
Studya
Informed consent
X
Inclusion and exclusion criteria
X
Prior sacituzumab govitecan parent 
study
X
Weight
X
Hematologyc
X
X
X
X
Serum chemistryd
X
X
X
X
Urine pregnancy teste
X
X
X
X
X
X
FSHf
X
Sacituzumab govitecan 
administration 
X
X
Concomitant medications
Throughout Study
SAEsg
Throughout Study
AEsg
Throughout Study
AE = adverse event; C1D1= Cycle 1 Day 1; FSH = follicle-stimulating hormone; SAE = serious adverse event
a
End of treatment (EOT) visit approximately 30 days of the last dose of the study drug. For the definition of End of Study (EOS), refer to Section 3.6.
b
For subjects of childbearing potential, the Safety Follow-up visits will be every 28 days for 6 months after study drug discontinuation. For subjects of non-childbearing 
potential who have ongoing AEs or SAEs at EOT, the Safety Follow-up visits will be every 6 weeks for up to 6 months after study drug discontinuation or until the criteria for 
EOS (Section 3.6) have been met. Subjects of non-childbearing potential who do not have ongoing AEs or SAEs at EOT will be considered as having reached EOS.
c
Hemoglobin, white blood cell (WBC) count and differential (with absolute neutrophil count [ANC]), and platelet count for all subjects is required at Day 1 and Day 8 of every 
Cycle, and EOT visit. ANC levels must be confirmed prior to each dose. May be obtained more frequently at the discretion of the managing physician if abnormal results 
warrant follow-up. Results of unscheduled tests should be documented. Refer to Section 6.3.2.3 for guidance regarding when sacituzumab govitecan should be administered 
based on ANC.

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d
Serum chemistries include total protein, albumin, total bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine 
(estimated glomerular filtration rate [GFR] using a validated model, refer to Appendix 3), blood urea nitrogen (BUN) or urea, glucose, sodium, potassium, magnesium, 
chloride, bicarbonate, calcium, phosphorus. Serum chemistries are required in all subjects at Day 1 and Day 8 of every cycle, and the EOT visit. Prior to administration of 
sacituzumab govitecan at C1D1, subjects are required to have creatinine clearance ≥ 30 mL/min.
e
The Cycle 1 Day 1 urine pregnancy test does not need to be conducted if the screening pregnancy test was performed within 72 hours before study treatment administration. 
Urine pregnancy testing will continue every 28 days up to 6 months after the last dose of study drug as discussed in Appendix 4. Testing during the Safety Follow-Up period 
may be performed at home and the result self-reported by the subject. If a urine pregnancy test is positive or equivocal, a confirmatory serum pregnancy test is required.
f
Conduct as needed per Appendix 4 for determination of childbearing potential.
g
Ongoing AEs and SAEs at EOT will be followed until resolution or stabilization in Safety Follow-up. For information on AEs beginning after EOT, please refer to 
Section 10.2.
NOTE: Unless otherwise specified, visit windows are within -1 and +7 days of the Treatment visits. Labs may be collected up to 3 days prior to dosing.

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5.
SELECTION AND WITHDRAWAL OF SUBJECTS
5.1.
Subject Inclusion Criteria
Subjects meeting all the following inclusion criteria at Screening/Day -1 will be eligible for 
participation in the study.
1) Female or male subjects, ≥ 18 years of age, able to understand and give written informed 
consent
2) Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously 
Immunomedics)-sponsored parent study
3) Continuing to receive clinical benefit from sacituzumab govitecan therapy
4) Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation.
5) 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 4.
5.2.
Subject Exclusion Criteria
Subjects meeting any of the following exclusion criteria at Screening/Day -1 of treatment will 
not be enrolled in the study.
1) Women who are pregnant or lactating (Appendix 4)
2) Initiated therapy with another cancer therapeutic agent (investigational or standard of care) 
since receiving the last dose of the study drug on the parent study in which they participated
3) Experienced a toxicity from sacituzumab govitecan that resulted in permanent 
discontinuation of therapy
4) Have an active serious infection requiring IV antibiotics (Contact medical monitor for 
clarification)
5) 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

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5.3.
Criteria for Treatment Discontinuation
Subjects will discontinue the treatment under any of the following conditions:
1) Withdrawal of consent from further treatment with study drug
2) Lost to follow-up. Subjects will be considered lost to follow up when there is no response to 
two attempts one month apart by phone and a registered letter. After these 3 failed attempts, 
lost to follow-up will be documented
3) An adverse event (AE) that, in the opinion of the Investigator or the sponsor, contraindicates 
further dosing
4) Initiation of alternative anti-tumor therapy, including any investigational agent
5) Pregnancy
6) Disease progression with no evidence of clinical benefit
7) Loss of clinical benefit
8) Subject non-compliance
9) Sponsor terminates the study
5.4.
Criteria for Study Discontinuation
Subjects will discontinue the study under any of the following conditions:
1) Death
2) Withdrawal of consent from study
3) Lost to follow-up. Subjects will be considered lost to follow up when there is no response to 
two attempts one month apart by phone and a registered letter. After these 3 failed attempts, 
lost to follow-up will be documented.
4) End of treatment, with documentation of resolution or stabilization of AEs (if applicable)
5) Sponsor terminates the study

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6.
TREATMENT OF SUBJECTS
6.1.
Description of Study Drug
Sacituzumab govitecan is a humanized mAb with a hydrolysable linker through which SN-38 is 
conjugated to the humanized mAb hRS7 IgG1κ to enhance the delivery of SN-38 to Trop-2- 
expressing tumors, while reducing systemic toxicity. SN-38 is the active metabolite of 
irinotecan.
6.2.
Investigational Medicinal Product, Dosage and Mode of Administration
Sacituzumab govitecan will be administered at the dose that the subject was receiving in the 
parent study at the time of consenting to participate in this rollover study. No dose escalation 
beyond the dose the subject was receiving in the parent study at the time of consenting to 
participate in this rollover study is permitted. No subject will receive more than 10 mg/kg dose 
of sacituzumab govitecan. Sacituzumab govitecan will be administered as an intravenous (IV) 
infusion on Days 1 and 8 of a 21-day cycle.
6.3.
Treatment of Sacituzumab Govitecan-Associated Toxicities
Instructions for the infusion of sacituzumab govitecan are provided in Section 7.5. The following 
sections provide guidance for sacituzumab govitecan administration and management of 
treatment-related toxicities, including modification of dosing and treatment discontinuation. 
Toxicities should be managed in accordance with standard institutional practices and accepted 
treatment guidelines.
6.3.1.
Preventative Medications
Infusion-Related Reactions: Premedication for prevention of infusion-related reactions (IRRs) 
with antipyretics and H1 and H2 blockers should be administered before each sacituzumab 
govitecan infusion. Corticosteroids (hydrocortisone 50 mg or equivalent orally [PO] or IV) may 
be administered prior to subsequent infusions. Additional details of recommended treatment of 
IRRs are described in Section 6.3.2.1.
Nausea, Vomiting: Sacituzumab govitecan is considered to be moderately emetogenic. 
Premedication with a 2-drug antiemetic regimen is recommended. If nausea and vomiting are 
persistent, a 3-drug regimen may be used, including a 5-HT3 inhibitor (ondansetron or 
palonosetron, or other agents according to local practices), an NK1-receptor antagonist 
(fosaprepitant or aprepitant), and dexamethasone (10 mg PO or IV). Anticipatory nausea can be 
treated with olanzapine. The recommended treatment of delayed nausea and vomiting is 
described in Section 6.3.2.2.

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6.3.2.
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 due to increased episodes of diarrhea or neutropenia, 
may have their polymorphism assessed per Investigator’s discretion. Instructions for 
sacituzumab govitecan dose reduction for treatment-related toxicities are provided in 
Section 6.3.2.5.
6.3.2.1.
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 and can occur at any cycle. 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 IRRs, sacituzumab govitecan should only be administered in 
a setting in which appropriately trained medical staff, emergency equipment, and medications are 
available in the event that resuscitation is required. NCI CTCAE v5.0 is used to grade the 
severity of all infusion-related AEs. Premedication for the prevention of IRRs is described in 
Section 6.3.1.
Grade 4 Events
Grade 4 reactions include potentially life-threatening reactions, requiring urgent intervention. If 
Grade 4 IRRs occur, sacituzumab govitecan should be permanently discontinued (Table 2).
Grade 2 and Grade 3 Events
Grade 2 IRRs are defined as those that require infusion interruption and respond to symptomatic 
treatment; prophylactic medications are indicated for ≤ 24 hours. For Grade 2 IRRs, the infusion 
should be interrupted until symptoms resolve. After symptoms resolve, the infusion should be 
resumed at a slower infusion rate determined appropriate by the managing physician. 
Recommended infusion rates are provided in the Pharmacy Manual. Grade 3 IRRs are defined as 
those that 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 or Grade 3 IRRs despite optimal management, 
sacituzumab govitecan should be permanently discontinued (Table 2).

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6.3.2.2.
Gastrointestinal Toxicities
Nausea, vomiting, and diarrhea are frequent sacituzumab govitecan-associated toxicities. 
Appropriate treatment, including, as needed, 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 gastrointestinal toxicities are provided in 
Section 6.3.2.5.
Nausea and Vomiting
Instructions for the use of premedications for prophylactic treatment of nausea and vomiting and 
anticipatory nausea are provided in Section 6.3.1. 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. Manage this toxicity per 
standard institutional guidelines. 
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, consider adding diphenoxylate/atropine and/or opium tincture, as clinically indicated.
Add octreotide 100-150 μg subcutaneous (SC) three times per day (tid) if diarrhea persists. 
Withhold sacituzumab govitecan for Grade 3 or 4 diarrhea at the time of scheduled treatment 
administration and resume when resolved to Grade ≤ 1. For Grade 3 or Grade 4 diarrhea, 
consider hospitalization, and treat with IV fluids, and octreotide. Antibiotics can be administered 
as clinically indicated. 
Subjects who exhibit an excessive cholinergic response to treatment with sacituzumab govitecan 
(eg, abdominal cramping, diarrhea, salivation, etc.) can receive appropriate premedication (eg, 
atropine) for subsequent treatments.
6.3.2.3.
Neutropenia
Complete blood counts (CBC) must be obtained prior to each sacituzumab govitecan infusion. 
Sacituzumab govitecan should be administered only if absolute neutrophil counts (ANC) meet 
the following criteria:

Day 1: ANC ≥1500/mm3

Day 8: ANC ≥1000/mm3
Sacituzumab govitecan should not be administered in cases of neutropenic fever.

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The routine prophylactic use of growth factors is not required; however, prophylactic 
administration may be considered and should comply with American Society of Clinical 
Oncology (ASCO) guidelines for use of growth factors. They may be used in subjects who have 
experienced febrile neutropenia or Grade 3 or Grade 4 neutropenia following previous infusions. 
Growth factors may also be administered in the setting of neutropenia in subjects at high risk of 
poor clinical outcomes, including those with prolonged neutropenia, ANC <1000/mm3, febrile 
neutropenia, and serious infections.
6.3.2.4.
Overdose
Overdose is defined as administration of a dose that is 10% higher 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 reported as described in Section 10.2.2.
6.3.2.5.
Sacituzumab Govitecan Dose Modification Guidelines
Dose Delays
Sacituzumab govitecan is to be administered in 21-day cycles on Day 1 and Day 8; the next 
cycle should start a minimum 14 days after the Day 8 dose (ie, the Day 8 infusion will be 
counted as the first day of that 14-day period). Dosing 1 day prior to and 7 days after the 
scheduled infusion are permitted. The scheduled Day 1 and Day 8 infusions may be delayed for 
up to one week for treatment-related toxicities.
Instructions for dose delays and dose reductions for specific toxicities are summarized below. 
For toxicities not specifically addressed in the toxicity management table (Table 2), dosing may 
be delayed for > Grade 2 toxicities for a maximum of one week. If the toxicity has improved to 
≤ Grade 2, the dose should be administered at that time. For a toxicity that delays Day 8 dosing, 
if the toxicity has not resolved to ≤ Grade 2 within one week, dosing should resume with the next 
scheduled cycle, ie, the next dose will be Day 1 of the following cycle. Regardless of whether the 
Day 8 dose is delayed for toxicity, there should be a minimum of 14 days between the Day 8 
infusion and the Day 1 infusion of the next cycle (day of delay is counted as day 1 of this 14-day 
period).
Dose Reductions and Discontinuation
The major toxicities of sacituzumab govitecan are expected to be gastrointestinal symptoms and 
hematologic suppression. All subjects will be closely monitored over the course of their 
treatment and aggressively medically managed, including dose reduction and interruption, in 
order to prevent the need for treatment discontinuation and serious complications of these 
toxicities. All efforts to avoid dose reduction should be taken to address toxicity prior to 
institution of dose reduction. Sacituzumab govitecan dose reductions and interruptions will be 
managed based on toxicity severity, as assessed by NCI CTCAE v5.0. Leukopenia or 
lymphopenia in the absence of neutropenia will not require dose delay or dose modification. The 
dose of sacituzumab govitecan must not be re-escalated following a dose reduction. Table 2 
summarizes recommendations for sacituzumab govitecan dose reductions and discontinuations 
for treatment-related toxicities.

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Table 2.
Recommended Dose Modification Schedule for Sacituzumab 
Govitecan
Adverse Reaction
Occurrence
Dose Modification or Action
Severe neutropenia 
First
25% dose reduction and 
administer G-CSF
Second
50% dose reduction
Grade 4 neutropenia ≥ 7 days,
OR
Grade 3-4 febrile neutropenia,
OR
At time of scheduled treatment, Grade 3 or 4 neutropenia that 
delays dosing by 2 or 3 weeks for recovery to ≤ Grade 1
Third
Discontinue treatment 
At time of scheduled treatment, Grade 3 or 4 neutropenia that 
delays dosing beyond 3 weeks for recovery to ≤ Grade 1
First
Discontinue treatment
Severe nonneutropenic toxicity
First
25% dose reduction
Second
50% dose reduction
Grade 4 nonhematologic toxicity of any duration, 
OR
Any Grade 3 or 4 nausea, vomiting, or diarrhea due to 
treatment that is not controlled with antiemetics and 
antidiarrheal agents 
OR
Other Grade 3 or 4 nonhematologic toxicity persisting 
> 48 hours despite optimal medical management,
OR
At time of scheduled treatment, Grade 3 or 4 nonneutropenic 
hematologic or nonhematologic toxicity that delays dose by 2 
or 3 weeks for recovery to ≤ Grade 1
Third
Discontinue treatment
In the event of Grade 3 or 4 nonneutropenic hematologic or 
nonhematologic toxicity that does not recover to ≤ Grade 1 
within 3 weeks 
First
Discontinue treatment
Infusion-Related Toxicities
Grade 2 or Grade 3 infusion-related reaction despite optimal 
management
Recurrent
Discontinue treatment
Grade 4 infusion-related reaction
First
Discontinue treatment
G-CSF = granulocyte colony-stimulating factor; NCI-CTCAE = National Cancer Institute-Common Terminology Criteria for 
Adverse Events
Refer to Section 10.2.2.6 for the NCI-CTCAE severity grading details.

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6.4.
Concomitant Medications
Medications initiated prior to the first dose of study drug will be recorded as prior medications 
with medications initiated following receipt 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 adverse events as outlined in the protocol should be documented with rationale for 
prophylactic intent.
Subjects must avoid the use of osteopathic traditional medicine and any other traditional 
medicine during the study.
No anti-cancer therapies, aside from the study drug 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 is 
permitted.
Treatment may be continued after completion of palliative radiotherapy. In this case, 
sacituzumab govitecan administration should be interrupted one week before the procedure and 
reinstated no earlier than two weeks after the procedure. In the event that a subject requires 
surgery, sacituzumab govitecan should be interrupted one 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, 
cranial surgeries for example, may require suspension of dosing for 4 weeks before dosing may 
resume to allow for an adequate period for healing.
The study medical monitor must approve continuation of therapy with sacituzumab govitecan 
prior to resumption of dosing. 
Subjects are allowed to receive the COVID-19 vaccine to reduce the risk and complications of 
COVID-19 infection. Details on the risk assessment and mitigation plan for concurrent 
administration of the COVID-19 vaccine are provided in Appendix 2.
6.5.
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 with sacituzumab govitecan 
should be avoided due to the potential to either increase (inhibitors) or decrease (inducers) the 
exposure to SN-38, unless there are no therapeutic alternatives.

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6.5.1.
UGT1A1 Inhibitors
Co-administration of sacituzumab govitecan with inhibitors of UGT1A1 (eg, atazanavir, 
gemfibrozil, indinavir) 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 5.
6.5.2.
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 5.
6.6.
Treatment Compliance
Sacituzumab govitecan will be administered at scheduled study centers 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 weight, and 
total 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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7.
STUDY DRUG MATERIALS AND MANAGEMENT
7.1.
Study Drug
The Investigational Medicinal Product (IMP) 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 (MES) buffer containing trehalose and polysorbate 80 and contains no 
preservatives. Following reconstitution, the concentration of the IMP is 10 mg/mL. The pH of 
the reconstituted solution is approximately 6.5.
7.2.
Study Drug Packaging and Labeling
Vials are intended for clinical use only and the label includes the study name or code, name of 
the IMP, lot number, strength and expiration date, as applicable. Sacituzumab govitecan will be 
supplied in cartons, each containing 1 vial.
7.3.
Study Drug Storage
The IMP is photosensitive and should be protected from light during storage, transport, and 
administration.
All vials of IMP must be stored under refrigeration (2 °C to 8 °C) and protected from light in a 
locked location that can be accessed only by the study Pharmacist, the Principal Investigator, or 
other duly authorized persons until administered to the subject. Additional information regarding 
study drug storage is presented in the Pharmacy Manual.
7.4.
Study Drug Preparation
Dose preparation must be documented according to institutional guidelines and all records must 
be kept in the study file.
The Pharmacist is required to follow the appropriate steps regarding the reconstitution and 
dilution of the study drug per the Pharmacy Manual.
7.5.
Administration
Sacituzumab govitecan is a cytotoxic drug. Follow applicable special handling and disposal 
procedures.

Administer IMP as an IV infusion

Infusions may be administered over 1 to 2 hours if previous infusions were well tolerated.

Protect the infusion bag from light.

An infusion pump may be used.

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
Compatibility with polypropylene infusion bags has been confirmed.

Compatibility with in-line filters and other ancillary infusion equipment has not been studied.

Do not mix IMP, or administer as an infusion, with other medicinal products.

Upon completion of the infusion, flush the IV line with 20 mL 0.9% Sodium Chloride 
Injection, United States Pharmacopeia (USP).
7.6.
Study Drug Accountability
The IMP must be stored in a locked location that can be accessed only by the Study Pharmacist, 
the Principal Investigator, or another duly authorized study/site personnel.
The IMP must not be used outside of the context of this protocol. Under no circumstances should 
the Investigator or other site personnel supply IMP to other Investigators, subjects, or clinics, or 
allow supplies to be used other than as directed by this protocol without prior written 
authorization from the sponsor.
Records documenting receipt, use, return, loss, or other disposition of the IMP must be kept. A 
complete drug accountability record should be maintained. In all cases, information describing 
study medication supplies and their disposition, subject-by-subject, must be provided and signed 
by the Investigator (or the pharmacist or other person who dispensed the drug) and collected by 
the study sponsor or designee. Requisite data include relevant dates, quantities, batches or code 
numbers, and subject identification for subjects who received IMP.
7.7.
Study Drug Handling and Disposal
7.7.1.
Study Drug Shipment
The IMP will be shipped at refrigerated temperature in an insulated shipper, protected from light 
and with a temperature monitoring device. The shipper must be opened immediately upon 
receipt.
7.7.2.
Receipt of IMP
All IMP should be inspected upon receipt as indicated on the Packing List. Follow instructions 
on the Packing List to complete any necessary forms and report issues or product complaints as 
directed in the Pharmacy Manual. Sites must retain all IMP vials affected and may not perform 
any additional testing on the vials in question.
If use of the interactive web-based response system (IWRS) is required, follow the process found 
in the study-specific IWRS Manual.
The study Pharmacist, or the Principal Investigator or designee must confirm that appropriate 
conditions have been maintained during transit and that any discrepancies are reported per 
guidance found in the Pharmacy Manual.

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7.7.3.
Study Drug Disposal
At the end of the study, or if instructed to do so during the study, the IMP may be destroyed at 
the site as dictated by the appropriate standard operating procedures at the participating 
institutions. IMP may not be destroyed until it has been reconciled and written confirmation has 
been received from the sponsor Study Contact or designee.
Destruction of IMP must be documented.
If local destruction is not possible, the IMP may be returned as per the agreed upon process. 
Return of IMP must be documented. The sponsor Study Contact or designee assigned to your site 
will assist with the return of IMP once it has been deemed appropriate by the sponsor.

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8.
ASSESSMENT OF EFFICACY
Efficacy will not be assessed in this study.

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9.
OTHER EVALUATIONS
Pharmacokinetics, immunogenicity, and ‘other’ evaluations will not be assessed for this study.

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10.
ASSESSMENT OF SAFETY
10.1.
Safety Parameters
10.1.1.
Weight
Weight will be measured as indicated in Table 1.
10.1.2.
Laboratory Assessments
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 judgement. 
All investigations will be assessed for all subjects as indicated in Table 1. 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. Clinically-significant abnormal results 
should be repeated within 24-48 hours or as per treating physician’s discretion to confirm 
abnormality and followed until resolution. The panels of laboratory tests to be performed are 
detailed below. For subjects rolling over from IMMU-132-15 or any new parent studies in the 
future, Gilead’s standard reference ranges will be used.
10.1.2.1.
Hematology
Hemoglobin, white blood cell (WBC) count and differential (with ANC), and platelet count to be 
performed as indicated in Table 1. ANC levels must be confirmed prior to each dose as described 
in Section 6.3.2.3.
10.1.2.2.
Serum Chemistry
Total protein, albumin, total bilirubin, alkaline phosphatase (ALP), alanine aminotransferase 
(ALT), aspartate aminotransferase (AST), creatinine (estimated glomerular filtration rate [GFR] 
using a validated model, refer to Appendix 3), blood urea nitrogen (BUN) or urea, glucose, 
sodium, potassium, magnesium, chloride, bicarbonate, calcium, phosphorus will be obtained for 
all subjects as indicated in Table 1.
10.1.2.3.
Pregnancy Test
In female subjects of childbearing potential, pregnancy testing will be performed according to 
the Schedule of Assessments (Table 1) and as presented in Appendix 4. 
10.1.2.4.
Follicle-Stimulating Hormone 
Follicle-stimulating hormone (FSH) testing will be conducted as needed per Appendix 4 for 
determination of childbearing potential.

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10.2.
Adverse Event Reporting
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.
10.2.1.
Safety Reporting Definitions
10.2.1.1.
Adverse Events
An 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 related to the investigational medicinal product.
Adverse events may include worsening or exacerbation of the disease under study; worsening or 
exacerbation of preexisting conditions or events; intercurrent illnesses; or drug interactions. 
Anticipated fluctuations of preexisting 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 preexisting condition for 
which the surgery is required, is the AE.
10.2.1.2.
Serious Adverse Events
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 was allowed to 
continue, might have caused death.

Requires inpatient hospitalization or prolongation of existing hospitalization (in the absence 
of a precipitating, clinical AE hospitalization is not in itself an SAE)

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
Results in persistent or significant disability/incapacity

Is a congenital anomaly/birth defect (in the child of a subject who was exposed to the study 
treatment)

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:

Progression of disease (See Section 10.2.2.9)

Hospitalization for a routine clinical procedure

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)
10.2.1.3.
 Special Situation Reports 
Special situation reports (SSRs) include all reports of medication error, abuse, misuse, overdose, 
occupational exposure, drug interactions, exposure via breastfeeding, unexpected benefit, 
transmission of infectious agents via the product, counterfeit of falsified medicine, and 
pregnancy regardless of an associated AE. 
Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration or administration of a study drug while the medication is in the control of a health 
care professional, patient, or consumer. Medication errors may be classified as a medication error 
without an AE, which includes situations of missed dose, medication error with an AE, 
intercepted medication error, or potential medication error.
Abuse is defined as persistent or sporadic intentional excessive use of a study drug by a subject.
Misuse is defined as any intentional and inappropriate use of a study drug that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a study 
drug given per administration or cumulatively that is above the maximum recommended dose as 
per protocol or in the product labeling (as it applies to the daily dose of the subject in question). 

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In cases of a discrepancy in drug accountability, overdose will be established only when it is 
clear that the subject has taken the excess dose(s). Overdose cannot be established when the 
subject cannot account for the discrepancy, except in cases in which the investigator has reason 
to suspect that the subject has taken the additional dose(s).
Occupational exposure is defined as exposure to a study drug as a result of one’s professional or 
nonprofessional occupation.
Drug interaction is defined as any drug/drug, drug/food, or drug/device interaction.
Unexpected benefit is defined as an unintended therapeutic effect where the results are judged to 
be desirable and beneficial. 
Transmission of infectious agents is defined as any suspected transmission of an infected agent 
through a sponsor study drug.
Counterfeit or falsified medicine is defined as any study drug with a false representation of (a) its 
identity, (b) its source, or (c) its history.
10.2.2.
Adverse Event and Special Situation Reporting
10.2.2.1.
Requirements for Collection of Events Before Study Drug Initiation
After informed consent, but before initiation of study drug, the following types of events must be 
reported on the applicable eCRFs: all SAEs and any AEs that are related to protocol-required 
procedures.
10.2.2.2.
Reporting Period for Adverse Events
Following initiation of study drug, collect all AEs, regardless of cause or relationship, until 
30 days after last administration of study drug and report the AEs on the eCRFs as instructed.
All AEs and clinically significant laboratory abnormalities should be followed until resolution or 
until the AE is stable, if possible. Gilead may request that certain AEs be followed beyond the 
protocol-defined follow-up period.
10.2.2.3.
Reporting Period for Serious Adverse Events
All SAEs, regardless of cause or relationship, that occur after the subject first consents to 
participate in the study (ie, signing the informed consent form) and throughout the duration of 
the study, including the Safety Follow-up visits, must be reported on the applicable eCRFs and to 
Gilead Global Patient Safety. This also includes any SAEs resulting from protocol-associated 
procedures performed after the informed consent form is signed.

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Any SAEs (including deaths; see Section 10.2.3 for exclusions) that occur during the study 
(including the Safety Follow-up visits detailed in the Schedule of Assessments [Table 1]) or 
within 30 days of the last dose of study drug or initiation of alternative therapy, whichever is 
later, should also be reported regardless of causality. 
Investigators are not obligated to actively seek SAEs after the protocol-defined 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. 
10.2.2.4.
Reporting Period for Special Situation Reports
All study drug SSRs that occur from study drug initiation and throughout the duration of the 
study, including the Safety Follow-up visits, must be reported to the sponsor.
10.2.2.5.
Adverse Event Collection and Documentation
Adverse Events Reporting Process
It is the responsibility of the Investigator to document all AEs that occur during the study. All 
adverse events regardless of seriousness, severity, or relationship to the study drug, that occur 
during the safety reporting period, must be recorded in the AE page of the eCRF. 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 laboratory tests and other study procedures. The Investigator must review all 
laboratory and test data; abnormal findings should be assessed to determine if they meet the 
criteria for adverse events (Section 10.2.1.1, Section 10.2.2.8).
For all AEs, the Investigator must pursue and obtain information adequate to assess whether it 
meets the criteria for classification as an SAE 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 adverse 
event. 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 on the 
eCRF.
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.
Adverse events and SAEs resulting from SSRs must be reported in accordance with the AE and 
SAE reporting guidance summarized in Sections 10.2.2.5 and 10.2.5.

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Serious Adverse Events Reporting Process
SAEs are to be recorded on the eCRF and SAE form. The SAE form must be forwarded to the 
sponsor or the sponsor’s designee 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 other relevant 
information, such as possible alternative etiologies.
Information captured on both the SAE form and entered into the eCRF should be consistent.
Special Situation Reporting Process
All SSRs will be recorded on the special situation report form and forwarded to the sponsor or 
sponsor’s designee in accordance with the timelines summarized in Section 10.2.2.5.
10.2.2.6.
Assessment of Adverse Event Severity
The severity of AEs will be graded using NCI CTCAE v5.0. For each SAE, the highest severity 
grade should be reported. If a CTCAE criterion does not exist, the Investigator should assess the 
severity according to the criteria in Table 3.
Table 3.
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 death3 
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.
ADL = activities of daily living; NCI-CTCAE = National Cancer Institute common terminology criteria for adverse events; 
SAE = serious adverse event.

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10.2.2.7.
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 treatment caused or contributed to an AE. In order 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, in particular, 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 that may have a known association with the event. Causality is to 
be assessed as follows:

Related: Plausible time relationship to study treatment 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 drug administration that 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.
10.2.2.8.
Adverse Events Based on Abnormal Test Findings
An abnormal test finding that meets any one 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 treatment 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.

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Laboratory results that fall outside the reference range and do not meet one of the criteria above 
should not be reported as AEs. Repeating an abnormal test, in the absence of the above 
conditions, does not constitute 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.
10.2.2.9.
Disease Progression
Disease progression should not be reported as an AE. It is important to differentiate expected 
disease progression from an AE. Events that are clearly consistent with the expected pattern of 
disease progression should not be considered AEs. Expected disease progression refers to an 
event that is unequivocally related to disease progression, and that the clinical course is 
consistent with what would be expected for the subject’s disease. A clinical event in the setting 
of disease progression would be considered an AE if it could not unequivocally be attributed to 
or consistent with expected disease progression.
Hospitalization due to signs and symptoms of disease progression (as defined above) should not 
be reported as an SAE.
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 or initiation of alternative therapy, whichever is later. Deaths that occur more 
than 30 days after the last dose of study drug or initiation of alternative therapy, whichever is 
later, 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 
an SAE (see Section 10.2.2.9) if, in the Investigator’s judgment, the event is unequivocally due 
to the expected course of progression of the underlying disease, and not due to another cause.
10.2.4.
Pregnancy Reporting Process
The investigator should report pregnancies in female study subjects that are identified after 
initiation of study drug and throughout the study (including through the protocol-required Safety 
Follow-up visits) or 6 months after the last study drug dose, whichever is longer, to Gilead 
Global Patient Safety using the pregnancy report form within 24 hours of the Investigator 
becoming aware of the pregnancy. 

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The investigator should report pregnancies in female partners of male subjects that are identified 
after initiation of study drug by the male subject and throughout the study (including through the 
protocol-required Safety Follow-up visits), or 3 months after the last study drug dose, whichever 
is longer, to Gilead Global Patient Safety using the pregnancy report form within 24 hours of the 
Investigator becoming aware of the pregnancy.
Contact details for transmitting the pregnancy report form are as follows:
Gilead Global Patient Safety
Email: Safety_FC@gilead.com
or
Fax: 1-650-522-5477
The pregnancy itself is not considered an AE, nor is an induced elective abortion to terminate a 
pregnancy without medical reasons.
All other premature terminations of pregnancy (eg, a spontaneous abortion, an induced 
therapeutic abortion due to complications or other medical reasons) must be reported within 
24 hours as an SAE, as described in Section 10.2.5. The underlying medical reason for this 
procedure should be recorded as the AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Section 10.2.5. Furthermore, any SAE occurring as an adverse pregnancy outcome after the 
study must be reported to Gilead Global Patient Safety.
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome of the pregnancy/partner pregnancy should be reported to Gilead 
Global Patient Safety using the pregnancy report form. If the end of the pregnancy/partner 
pregnancy occurs after the study has been completed, the outcome should be reported directly to 
Gilead Global Patient Safety. Gilead Global Patient Safety contact information is as follows: 
email: Safety_FC@gilead.com and fax: +1 (650) 522-5477.
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 of becoming aware of the event.
The initial SAE report should be as complete as possible (Section 10.2.2.5); however, reporting 
should not be delayed in order to obtain more information. The SAE should also be entered on 
the applicable eCRF. All follow-up information should be reported within 24 hours of the 
Investigator’s awareness of the information. The Investigator is required to provide follow-up 
information in response to queries from the sponsor or the 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 should be reported to the contact indicated on the SAE form and 
entered on the applicable eCRF.

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10.2.6.
Investigator Notification to Local Institutional Review Boards/Ethics 
Committees
The Investigator must notify their local Institutional Review Board (IRB)s/ECs about certain 
AEs including suspected unexpected serious adverse reactions (SUSARs) in accordance with 
their IRBs’/ECs’ policies and procedures and Good Clinical Practice (GCP)/International 
Conference on Harmonisation (ICH) 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/ECs in accordance with all 
applicable regulations and guidance documents.

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STATISTICS 
11.1. 
Sample Size Determination 
Final 
Amendment 1 
The sample size ofup to approximately 200 subjects assumes that 10-15% of subjects in an 
ongoing sacituzumab govitecan parent studies will rollover to this study upon closure of the 
parent study. 
11.2. 
Populations for Analyses 
All Treated Subjects: All subjects who received at least one dose of sacituzumab govitecan. 
11.3. 
Statistical Analyses 
11.3.1. 
Endpoints 
The primaiy endpoints ai·e as follows: 
• 
Percentage of paiiicipants experiencing any AE 
• 
Percentage of paiiicipants experiencing any SAE 
• 
Percentage of paiiicipants experiencing any laborato1y abno1mality 
11.3.2. 
Efficacy Analyses 
Efficacy will not be analyzed. 
11.3.3. 
Safety Analyses 
Safety analyses will be based on All Treated Subjects. All safety analyses will be presented by 
cancer types and histology when deemed appropriate. Safety data will be sUilllnai·ized using 
descriptive statistics. Categorical vai·iables will be sUilllnai·ized by number and percentage. 
Continuous variables will be sUilllnarized using n (number of subjects with available data), 
mean, standard deviation, median, upper and lower quaiiiles, and range (minimum and 
maximum), unless othe1w ise specified. 
A treatment-emergent AE will be defined as any AE that begins on or after the date of first dose 
of study drng up to the date of last dose of study drng plus 30 days. Treatment-emergent 
laborato1y abnonnalities will be defined as values that increase at least 1 toxicity grade from 
baseline at any time after baseline up to and including the date of last dose of study drng plus 
30 days. Treatment-emergent AEs and SAEs and clinical laborato1y test results will be 
smnmai·ized. Study drng exposure and concomitant medications will also be smnmai·ized. 
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12.
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS
12.1.
Study Monitoring
Monitoring procedures developed by the sponsor or its designee will be followed, in order to 
comply with ICH GCP, Food and Drug Administration (FDA) and applicable guidelines. Review 
of the subject’s eCRFs, electronic medical/health records, or paper source documentation for 
completeness and accuracy will be required, and a review of all applicable regulatory documents 
will be performed. All available source documents should be obtained by the Investigator and 
provided to the sponsor’s designee for review at each monitoring visit. Monitoring visits to the 
study site will be conducted periodically during the study to ensure that GCP and all aspects of 
the protocol are followed.
Queries may be issued in the eCRF system to be addressed by the appropriate study site 
personnel within a timely manner when clarification of eCRF data is required to ensure data 
accuracy and completeness. The sponsor’s designee will ensure that the investigation is 
conducted according to protocol design and regulatory requirements by frequent 
communications.
Regulatory authorities, the IRB/Independent Ethics Committee (IEC), and/or the sponsor’s 
Clinical Quality Assurance group or designee may request access to all source documents, 
subject’s eCRFs, and other study documentation for on-site audit or inspection. Access to these 
documents must be guaranteed by the Investigator, who must cooperate and provide support at 
all times for these activities as allowed by standard operating procedure or policy of their 
institution.
12.2.
Audits and Inspections
Authorized representatives of the sponsor, a regulatory authority, an Independent EC or an IRB 
may visit the site to perform audits or inspections, including source data verification. The 
purpose of a sponsor’s audit or inspection is to systematically and independently examine all 
study-related activities and documents to determine whether these activities were conducted, and 
data were recorded, analyzed, and accurately reported according to the protocol, Good Clinical 
Practice (GCP) guidelines of the ICH, and any applicable regulatory requirements. The 
Investigator should contact the sponsor immediately if contacted by a regulatory agency about an 
inspection.
12.3.
Institutional Review Board /Independent Ethics Committee
The Principal Investigator must obtain IRB/IEC approval for the investigation. Initial IRB/IEC 
approval, and all materials approved by the IRB/IEC for this study including the subject consent 
form and recruitment materials must be maintained by the Investigator and made available for 
inspection.

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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.
The study site may 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. 
Investigator(s) and their relevant personnel must agree to be available and participate with audit 
visits conducted at a reasonable time in a reasonable manner, Investigator/Institution must 
guarantee direct access to source documents by the sponsor and its designee, and appropriate 
regulatory authorities.
Global regulatory authorities may also audit 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 audits conducted at a reasonable time in a reasonable 
manner.

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14.
ETHICS
14.1.
Ethics Review
The final study protocol, including the final version of the Informed Consent Form, must be 
approved or given a favorable opinion in writing by an IRB or IEC as appropriate. The 
investigator must submit written approval to the sponsor before he or she can enroll any subject 
into the study.
The Principal Investigator is responsible for informing the IRB or IEC of any amendment to the 
protocol in accordance with local requirements. In addition, the IRB or IEC must approve all 
advertising used to recruit subjects for the study. The protocol must be re-approved by the IRB 
or IEC upon receipt of amendments and annually, as local regulations require.
The Principal Investigator is also responsible for providing the IRB with reports of any 
reportable serious adverse drug reactions from any other study conducted with the investigational 
product. The sponsor will provide this information to the Principal Investigator.
Progress reports and notifications of serious adverse drug reactions will be provided to the IRB 
or IEC according to local regulations and guidelines.
14.2.
Ethical Conduct of the Study
This study is planned to be conducted both in the US, Europe, and rest of the world countries. 
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 (as 
mandated for European studies), and applicable local regulatory requirements and laws. In the 
United States, ethical protection is provided by compliance with GCPs as described in ICH and 
21 Code of Federal Regulation (CFR) 50 (Protection of Human Subjects).
The IRB and the IEC will review all appropriate study documentation in order 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.
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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14.3.
Written Informed 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 primary care 
physician of the subject’s participation in the study if the subject agrees to the Investigator 
informing the primary care physician.
14.4.
Good Clinical Practice
The study will be conducted in accordance with the ICH E6 GCP and the appropriate local and 
national regulatory requirement(s). The Investigator will be thoroughly familiar with the 
appropriate use of the study medications as described in the protocol and investigator’s brochure.
Essential clinical documents will be maintained to demonstrate the validity 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.
14.5.
Protocol Compliance
The Investigator will conduct the study in compliance with the protocol provided by the sponsor 
or its designee and given approval by the IRB/IEC and the appropriate regulatory authorities. 
Modifications to the protocol should not be made. Changes to the protocol will require written 
IRB/IEC approval prior to implementation, except when the modification is needed to eliminate 
an immediate hazard(s) to the subject. The IRB/IEC may provide, if applicable, regulatory 
authorities permit, expedited review and approval for minor change(s) in ongoing studies that 
have 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.

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When immediate deviation from the protocol is required to eliminate an immediate hazard(s) to 
subjects, the Investigator will contact the sponsor’s designee, if circumstances permit, to discuss 
the planned course of action. Any departures from the protocol must be fully documented in the 
subject’s source documentation.
14.6.
Subject Data Protection
Information collected in this clinical study is subject to the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) as described in 45 CFR 160 and 45 CFR 164, as well as the 
REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE 
COUNCIL of 27 April 2016 (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.
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, sponsor, designee, 
and the IRB/IEC for each study site.
14.7.
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. 
Since the results of this study may eventually be used in a marketing application, compliance 
with this Federal statute is essential. In order to comply with the provisions of this regulation, the 
sponsor requests that every Investigator and sub-Investigator mentioned on FDA Form 1572 or 
its equivalent 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 
Investigator 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 clinical 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 

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to notify the sponsor. To assist the sponsor or designee in providing the FDA with the required 
information, please 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.
14.8.
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 time period 
set by the sponsor. In the unlikely event of premature termination or discontinuation of the study, 
in the event the Investigator believes a subject is continuing to receive clinical benefit, the 
sponsor will discuss options with the Investigator in order 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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15.
DATA HANDLING AND RECORDKEEPING
15.1.
Inspection of Records
The sponsor or its designee will be allowed to conduct site visits to the investigation facilities for 
the purpose of monitoring any aspect of the study. The Investigator agrees to allow the monitor 
to inspect the drug storage area, study drug stocks, drug accountability records, subject charts 
and study source documents, and other records relative to study conduct.
15.2.
Retention of Records
Records and documents pertaining to the conduct of this study, including eCRFs, source 
documents, consent forms, laboratory test results, and medication inventory records must be 
retained by the Investigator for at least 15 years. No study records shall be destroyed without 
prior authorization from the sponsor. For studies conducted outside the US under a US 
Investigational New Drug (IND), 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 two years following approval of a Biologic License Application, or, if the Biologic License 
Application is not approved, until two years following notification by the sponsor that the 
clinical investigations have been discontinued.
15.3.
Electronic Case Report Forms
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. 
eCRFs must be signed by the Investigator or by an authorized staff member. 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. Subject source documents are the 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.
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 site personnel 
will address all queries per site agreement with the sponsor during the course of the study and 
afterwards to ensure data accuracy and completeness.

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16.
PUBLICATION POLICY
The conditions regulating dissemination of the information derived from this clinical study are 
described in the Clinical Study Agreement.

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17.
LIST OF REFERENCES
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.
Cardillo TM, Sharkey RM, Rossi DL, Arrojo R, Mostafa AA, Goldenberg DM. Synthetic 
Lethality Exploitation by an Anti-Trop-2-SN-38 Antibody-Drug Conjugate, 
IMMU-132, Plus PARP Inhibitors in BRCA1/2-wild-type Triple-Negative Breast 
Cancer. Clin Cancer Res 2017;23 (13):3405-15.
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 
1976;16 (1):31-41.
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.

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18.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Pandemic Risk Assessment and Mitigation Plan
Appendix 3.
Cockcroft-Gault Formula
Appendix 4.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 5.
UGT1A1 Inhibitors and Inducers

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Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
Final 
Amendment I 
(IMMUNOMEDICS, INC. IS NOW PART OF THE Gll,EAD GROUP OF COMP Al""lIES) 
333 LAKESIDE DRIVE 
FOSTER CITY, CA 94404 
STUDY ACKNOWLEDGMENT 
Open-label Rollover Study to Evaluate Long-Term Safety in Subjects with Metastatic Solid 
Tumors that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan 
IMMU-132-14, Protocol Amendment 1, 27 August 2021 
This protocol has been approved by Gilead Sciences, Inc. (Immunomedics, Inc. is now part of 
the Gilead group of companies). The following signature documents this approval. 
PD 
PPD 
Name (Printed) 
Signature 
Vice President, Clinical Development 
PPD 
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 w~ll 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 drugs and the study. 
Principal Investigator Name (Printed) 
Signature 
Date 
Site Number 
CONFIDENTIAL 
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Appendix 2.
Pandemic Risk Assessment and Mitigation Plan
During an ongoing pandemic, 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 assessments.
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 AEs/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. 

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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 pandemic 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 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 pandemic 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 pandemic will be documented as a protocol deviation related to the pandemic.
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:
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 a pandemic 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 
pandemic 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 drug.
Mitigation plan: There is not substantial efficacy or 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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Appendix 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
{Cockcroft 1976}

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Appendix 4.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1) Definitions
a. Definition of Childbearing Potential
For the purposes of this study, a female-born subject 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.
Women 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, women younger than 54 years with amenorrhea of at least 12 months also 
may be considered postmenopausal if their FSH 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 subject of any age.
b. Definition of Male Fertility
For the purposes of this study, a male-born subject is considered fertile after the initiation of 
puberty unless the subject is permanently sterile by bilateral orchidectomy or medical 
documentation.
2) Contraception Requirements for Female Subjects
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. A negative urine 
pregnancy test is required at baseline prior to study treatment administration on 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 the last 
cycle and every 28 days after the last dose of study drug until the end of contraception 
requirement. If a urine pregnancy test is positive or equivocal, a confirmatory serum pregnancy 
test will be required.

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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. 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 5 for a list 
of UGT1A1 inducers and Section 6.5)
b) Injectable progesterone
c) Subdermal contraceptive implant
d) Transdermal contraceptive patch
e) Contraceptive vaginal ring

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)

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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 Male Subjects
It is theoretically possible that a relevant systemic concentration of study drug may be achieved 
in a female partner from exposure of the male subject’s seminal fluid and poses a potential risk 
to an embryo/fetus. Therefore, male subjects with female partners of childbearing potential must 
use condoms during treatment and until 6 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 subjects must also refrain from sperm donation, and/or cryopreservation of germ cells 
during treatment and until the end of contraception requirement. Male subjects 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), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.
5) Procedures to be Followed in the Event of Pregnancy
Female subjects 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. 
Sacituzumab govitecan must be discontinued immediately upon consultation with the medical 
monitor.
Male subjects 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 dose of study drug, 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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Appendix 5.
UGT1A1 Inhibitors and Inducers
Inhibitors of UGT1A1
Inducers of UGT1A1
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
Carbamazepine
Efavirenz 
Ethinylestradiol
Lamotrigine 
Phenobarbital
Phenytoin 
Primidone 
Rifampicin 
Ritonavir 
Tipranavir