A Multi-arm, Phase 2 Study to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed on Second Generation AR-Directed Therapy
Phase: PHASE2
Conditions: Prostate Cancer
Sponsor: University of Wisconsin, Madison

 
 
 
Sacituzumab Govitecan in Patients With 
Metastatic Castration-Resistant Prostate 
Cancer Progressing on Second Generation 
AR-Directed Therapy 
NCT03725761 
MAY 12, 2022 

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CONFIDENTIALITY STATEMENT 
The information in this document is provided to you as an investigator, potential investigator, 
consultant, or contractor, for review by you, your staff, and the appropriate Institutional Review Board 
or Ethics Committee. By accepting this document, you agree that the information contained herein will 
not be disclosed to others without written authorization from the lead site/sponsor, except to the 
extent necessary to initiate the study or conduct study-related activities. 
A Multi-arm, Phase 2 Study to Evaluate the Safety and Efficacy of 
Sacituzumab Govitecan in Patients with Metastatic Castration-Resistant 
Prostate Cancer Who Have Progressed on Second Generation AR-Directed 
Therapy 
 
Prostate Cancer Clinical Trials Consortium, LLC (PCCTC) 
PCCTC #: c18-204 
IND #: 140489 
University of Wisconsin 
 
Sponsor-Investigator 
Joshua M. Lang, MD, MS 
Carbone Cancer Center 
University of Wisconsin 
7151 Wisconsin Institutes for Medical Research 
1111 Highland Ave. 
Madison, WI 53705-2225 
email: jmlang@medicine.wisc.edu 
Protocol Management 
Prostate Cancer Clinical Trials Consortium 
Email: pcctc@mskcc.org 
 
 
 
 
 
Protocol Date: 
Version 1: 06-Jun-2018 
Version 2: 28-Sep--2018 
Version 3: 20-Dec-2019 
Version 4: 23-Sep-2021 
Version 5: 12-May-2022 
 
 
 
 

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APPROVAL OF PROTOCOL 
 
 
Title: 
A Multi-arm, Phase 2 Study to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Patients 
with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed on Second Generation AR- 
Directed Therapy 
 
 
 
 
Sponsor/Sponsor-Investigator Signature:  
 
 
Print: 
 
 
 
Date: 
 
 
 
 
 
PCCTC Signature:  
 
 
Print: 
 
 
 
Date: 
 
 

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PROTOCOL AGREEMENT 
 
 
I have read the protocol specified below. In my formal capacity as Investigator, my duties include ensuring 
the safety of the study subjects enrolled under my supervision and providing the University of Wisconsin 
with complete and timely information, as outlined in the protocol. It is understood that all information 
pertaining to the study will be held strictly confidential and that this confidentiality requirement applies 
to all study staff at this site. Furthermore, on behalf of the study staff and myself, I agree to maintain the 
procedures required to carry out the study in accordance with accepted Good Clinical Practice (GCP) 
principles, as adopted by applicable laws and regulations, and to abide by the terms of this protocol. 
 
 
 
 
 
 
 
 
 
Principal Investigator Signature:  
 
 
Principal Investigator Print:  
 
 
Date:  
 

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TABLE OF CONTENTS 
1. 
INTRODUCTION ......................................................................................................................................... 6 
1.1 
Study Rationale ......................................................................................................................................... 6 
1.2 
Prostate Cancer ........................................................................................................................................ 7 
1.3 
Sacituzumab Govitecan Pharmacology, Pre-clinical and Clinical Experience ........................................... 7 
1.4 
New Biomarkers in Prostate Cancer ....................................................................................................... 11 
2. 
OBJECTIVES ............................................................................................................................................. 14 
2.1 
Primary Objective ................................................................................................................................... 14 
2.2 
Secondary Objectives ............................................................................................................................. 14 
2.3 
Exploratory Objective ............................................................................................................................. 14 
3. 
STUDY POPULATION ................................................................................................................................ 14 
3.1 
Inclusion Criteria ..................................................................................................................................... 15 
3.2 
Exclusion Criteria .................................................................................................................................... 16 
4. 
ENROLLMENT PLAN ................................................................................................................................. 17 
4.1 
Number of Subjects ................................................................................................................................ 18 
4.2 
Eligibility Confirmation ........................................................................................................................... 18 
5. 
STUDY PROCEDURES................................................................................................................................ 18 
5.1 
Screening Activities ................................................................................................................................. 19 
5.2 
Study Procedures .................................................................................................................................... 19 
5.3 
Determination of Extent of Metastatic Disease ...................................................................................... 20 
5.4 
Laboratory Evaluations ........................................................................................................................... 20 
5.5 
Correlative biomarker studies ................................................................................................................ 21 
5.6 
End of Treatment Evaluation or Unscheduled/Early Termination Visit ................................................... 22 
5.7 
Long-Term Follow-Up ............................................................................................................................. 22 
5.8 
Criteria for Removal from Protocol Treatment ....................................................................................... 22 
6. 
INVESTIGATIONAL MEDICINAL PRODUCT AND STUDY TREATMENT .......................................................... 23 
6.1 
Sacituzumab Govitecan Formulation ...................................................................................................... 23 
6.2 
Sacituzumab Govitecan Packaging and Storage..................................................................................... 24 
6.3 
Sacituzumab Govitecan Preparation and Administration ...................................................................... 24 
6.4 
Dose modification of Sacituzumab Govitecan ........................................................................................ 29 
6.5 
Concomitant Therapy ............................................................................................................................. 32 
6.6 
Drug Accountability ................................................................................................................................ 33 
7. 
SAFETY EVALUATION ............................................................................................................................... 34 
7.1 
Definitions .............................................................................................................................................. 34 
7.2 
Documenting Adverse Events ................................................................................................................. 36 
7.3 
Reporting of Adverse Events and Serious Adverse Events ...................................................................... 37 
7.4 
Grading and Relatedness of Adverse Events .......................................................................................... 39 
7.5 
Follow-up of Unresolved Adverse Events ............................................................................................... 40 
8. 
STATISTICAL CONSIDERATIONS ................................................................................................................ 40 
8.1 
Data Management .................................................................................................................................. 40 
8.2 
Study Design ........................................................................................................................................... 41 
8.3 
Determination of Sample Size ................................................................................................................ 41 
8.4 
Analysis Populations ............................................................................................................................... 42 
8.5 
Correlative Biomarker Analysis ............................................................................................................... 43 
9. 
ADMINISTRATIVE PROCEDURES ............................................................................................................... 44 
9.1 
Pre-Study Documentation ...................................................................................................................... 44 
9.2 
Source Documents .................................................................................................................................. 44 
9.3 
Study Ethics ............................................................................................................................................ 45 

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9.4 
Data and Safety Monitoring .................................................................................................................... 46 
9.5 
Confidentiality ........................................................................................................................................ 48 
9.6 
Protocol Amendments ............................................................................................................................ 48 
9.7 
Protocol Compliance ............................................................................................................................... 49 
9.8 
Site Monitoring and On-Site Audits ........................................................................................................ 49 
9.9 
Patient Data Protection .......................................................................................................................... 50 
9.10 Financial Disclosure ................................................................................................................................ 50 
9.11 Discontinuation Criteria .......................................................................................................................... 51 
10. 
DISSEMINATION AND PUBLICATION OF RESULTS ..................................................................................... 51 
11. 
REFERENCES ............................................................................................................................................ 52 
APPENDIX A: PERFORMANCE STATUS CRITERIA ................................................................................................. 56 
APPENDIX B: STUDY CALENDAR ......................................................................................................................... 57 
APPENDIX C: ELEMENTS OF INFORMED CONSENT .............................................................................................. 59 
APPENDIX D: THE DECLARATION OF HELSINKI .................................................................................................... 60 
APPENDIX E: PROSTATE CANCER WORKING GROUP 2 (PCWG2) REPONSE CRITERIA ............................................ 64 
APPENDIX F: GLOSSARY OF ABBREVIATIONS AND ACRONYMS ........................................................................... 65 

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1. 
INTRODUCTION 
1.1 
Study Rationale 
Androgen Receptor Signaling Inhibitors (ARSIs) including the CYP-17 inhibitor abiraterone acetate 
(administered with prednisone) and the next generation anti-androgen enzalutamide have been 
shown to improve survival in patients with prostate cancer.1,2 This includes patients with newly 
diagnosed, metastatic hormone sensitive prostate cancer and those with castration-resistant 
prostate cancer (CRPC).3,4 Abiraterone acetate inhibits CYP17 leading to a reduction in androgen 
biosynthesis but by targeting both the 17-OH and the lyase portion of the enzyme, glucocorticoid 
production is also reduced and there is unopposed production of mineralocorticoids.5,6 
Prednisone acts centrally to reduce mineralocorticoid production, reducing the side effects of 
mineralocorticoid excess. Enzalutamide is a next-generation anti-androgen that has greater 
avidity to the androgen receptor (AR) than first generation compounds, and uniquely inhibits 
nuclear translocation of the AR to the nucleus, and binding of the receptor complex to DNA.6 
A review of the post-therapy PSA change patterns seen with these agents can be categorized into 
three distinct categories: rapid and durable declines consistent with sensitivity, no decline 
consistent with intrinsic resistance or decline and later progression consistent with acquired 
resistance.7 These mechanisms of resistance can be quite diverse, extending from genomic 
alterations (e.g., AR amplifications/point mutations/rearrangements), transcriptomic alterations 
(e.g., AR splice variants) and neuroendocrine differentiation among others8-12. We are at an early 
understanding of the frequency of patients with these signatures and the timing during which 
these resistance mechanisms develop. The clinical and therapeutic impact of these alterations is 
observed in retrospective studies showing the response to enzalutamide in patients who have 
been treated with abiraterone acetate plus prednisone,13,14 and separately, the response to 
abiraterone acetate plus prednisone in patients previously treated with enzalutamide15,16 is 
significantly lower than patients not previously treated with either drug (Table 1). Equally 
important is that sensitivity to one does not predict sensitivity to the other: some patients show 
sensitivity or resistance to both, while others respond to one and not the other. Patients 
progressing on either of these oral agents are faced with the prospect of intravenous cytotoxic 
chemotherapy using docetaxel or platinum doublets, or the use of Radium 223 in patients with 
bone only metastases as the next-line treatment. These limited options create a critical need for 
new therapies that target resistant prostate cancer, including single agent and combination 
strategies. 
This study will investigate the safety and efficacy of Sacituzumab Govitecan in patients 
progressing on ARSIs. Patients who have progressed while on therapy with combination 
enzalutamide/abiraterone or ARN-509/abiraterone as part of ongoing clinical trials are allowed 
and may be enrolled in the study. To better understand the heterogeneity of response and in 
particular to identify patients likely to benefit, an extensive correlative biomarker program will be 
included to collect and analyze tumor tissue biopsies, circulating tumor cells (CTCs), and 
circulating tumor DNA (ctDNA). 
A validated predictive biomarker would benefit the individual patient by enabling him to be 
treated with a safe effective oral drug and avoid one from which he is unlikely to benefit. It is also 
essential for prostate cancer drug development because the increasing availability of more life- 

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prolonging therapies is making it more difficult to prove a survival benefit for the next promising 
agent. 
1.2 
Prostate Cancer 
Prostate cancer is the most common cancer in men, and the second leading cause of cancer 
deaths in men.17 In men with early-stage (localized) prostate cancer, currently available local 
therapies are successful: 8-year freedom from metastatic disease is 97% in men undergoing 
radical prostatectomy and 93% in men undergoing radiation therapy.18 However, once prostate 
cancer has spread beyond the prostate gland or the immediate surrounding tissue, systemic 
therapy is indicated. 
First-line systemic treatment for metastatic disease with androgen deprivation therapy (ADT) has 
long been shown to lead to a decline in PSA and tumor regression. The addition of abiraterone 
acetate or docetaxel in men with hormone sensitive, metastatic prostate cancer has been shown 
to improve survival compared to ADT alone.3,4,19 Unfortunately, these treatments are not curative 
and men invariably develop a rise in PSA and tumor growth as a castration resistant tumor (CRPC) 
which for most men is lethal. Approved therapies shown to confer a survival benefit in men with 
CRPC include: Sipuleucel-T, abiraterone acetate plus prednisone, enzalutamide, apalutamide, 
darolutamide, docetaxel, cabazitaxel, and radium-223.2,20-24 For men with CRPC, abiraterone 
acetate plus prednisone and enzalutamide are often used as first-line systemic treatment for 
CRPC, unless abiraterone was used in the hormone sensitive setting. After progression on either 
one of these agents the likelihood of response to the other is lower than in the first-line setting 
(Table 1). Specifically, PSA response rates (≥50% decline from baseline) to enzalutamide after 
progression on abiraterone are 21-27% in docetaxel-naïve patients.15,16 Many patients seek to 
avoid cytotoxic therapy and, even before the more recently approved drugs became available, a 
significant proportion of these men did not receive it. The identification of an effective therapy 
after progression on enzalutamide or abiraterone represents a significant unmet clinical need that 
would spare patients the toxicity of an intravenous cytotoxic therapy that is similarly less 
efficacious in the post-AR and AR signaling directed therapy. 
 
Table 1. PSA response rate (≥50% decline) to abiraterone 
acetate/prednisone, enzalutamide or docetaxel is lower after prior 
AR targeted treatments 
Response rate 
first-line 
2,20,23 
Response rate 
second-line 15,16,25- 
27 
Response rate 
third- line 13,14,28,29 
Enzalutamide 
78% 
25% 
~20% 
Abiraterone 
62% 
25% 
~5% 
Docetaxel 
48% 
35% 
NR 
Response defined as ≥50% decline in PSA from baseline at any time point 
1.3 
Sacituzumab Govitecan Pharmacology, Pre-clinical and Clinical Experience 
Sacituzumab Govitecan is a novel Antibody Drug Conjugate (ADC) based on a humanized anti- 
Trop-2 antibody (hRS7) conjugated to an SN-38 payload. Trop-2 (trophoblastic cell-surface 
antigen; also known as EGP-1, epithelial glycoprotein-1), is a cell surface, transmembrane calcium 
signal transducer glycoprotein belonging to the TACSTD gene family that is highly expressed in 
many epithelial cancers, particularly metastatic sites, with much lower expression in normal 
tissues. Trop-2 has been implicated as an important antigen in oncogenesis, often being found in 

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more aggressive tumors.30 The murine RS7 antibody was initially identified as being specific for 
epithelial glycoprotein-1 (aka, Trop-2), being found in a number of different epithelial cancers and 
it was internalized,31-33 a highly desirable property for an antibody-drug conjugate. While Trop-2 
is highly conserved among various species, the hRS7 antibody does not bind to murine Trop-2, 
but an immunohistology study of monkey tissues showed hRS7 bound to Trop-2 and had a similar 
distribution as found in humans.34 Thus, a toxicology study was performed with Sacituzumab 
Govitecan with the purpose to assess the dose-limiting toxicity and to determine if Trop-2 
expressing normal tissues would limit the use of this conjugate. Two doses were administered 
within one week (3 days apart) at a cumulative amount of 120 and 240 mg/kg (1.92 and 3.84 
mg/kg of SN-38; human equivalent dose of the conjugate was 38.7 and 77.4 mg/kg).34 At 120 
mg/kg, there was evidence of myelosuppression, within 3 days, but the decrease in counts did 
not achieve gradable levels and were completely restored within 10-14 days. No significant 
change in serum chemistries or tissue pathology was noted. At the 240 mg/kg, severe GI and 
hematological toxicities occurred, and thus the maximum tolerated dose had been exceeded. 
Thus, the conjugate displayed a similar toxicity profile as irinotecan itself has major 
gastrointestinal and hematologic toxicity. Importantly, there were no serious histopathological 
changes to tissues with known hRS7 binding in the monkey, with the exception of mild to 
moderate hemorrhage of the endometrium and atrophy of the endometrial glands that were 
showing recovery at the time the study was terminated. (See Investigator Brochure for 
additional information on Sacituzumab Govitecan). 
Pharmacokinetic analysis of the clearance of the hRS7 IgG and SN-38 (as free SN-38, total SN-38, 
and a derived IgG-bound SN-38) in monkeys showed the IgG cleared at what appeared to be an 
expected rate (e.g., 30% cleared over 1 day, terminal half-life ~5 days). The clearance parameters 
for the total and IgG-bound SN-38 were very similar, with a half-life of ~13 h, which reflect the 
clearance of the IgG and the fact that the SN-38 is released from the conjugate at a rate of ~50% 
every 20 h. As expected, the AUC for the total and IgG-bound SN-38 was nearly 15-times higher 
than for free SN-38, which had a half-life of ~25 h, similar to the rate reported for SN-38 released 
from irinotecan. Thus, the conjugate can liberate low concentrations of SN-38 in the serum at a 
slow and sustained rate. These properties are similar in humans.35 
The chemotherapy backbone of Sacituzumab Govitecan , SN-38 (the active metabolite of 
irinotecan) is a topoisomerase-I-inhibiting camptothecin. The SN-38 active moiety of irinotecan, 
has already been studied in subjects with diverse tumor types and the FDA approved irinotecan 
as first line therapy for patients with metastatic colorectal cancer in conjunction with 5-FU and 
leucovorin. The SN-38 moiety of Sacituzumab Govitecan has >100-fold more cytotoxic activity 
compared to the parent compound, irinotecan, and is therefore hypothesized as being more 
active against the targeted tumors over-expressing Trop-2 antigen. Further, Sacituzumab 
Govitecan has a better therapeutic index than irinotecan. This improved therapeutic index and 
encouraging activity has been corroborated in the phase I trial when Sacituzumab Govitecan was 
given to subjects with diverse metastatic cancers,36 including triple-negative breast cancer 
(TNBC),37 urothelial cancer,38 and non-small-cell and small cell lung cancers,39,40 demonstrating 
activity and manageable toxicity profiles in subjects with advanced and heavily-pretreated, 
metastatic diseases. 
Since SN-38 is not water soluble, it was derivatized to form the water-soluble irinotecan. 
However, irinotecan must be enzymatically cleaved to the active SN-38 form for it to have 

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maximum potency. Unfortunately, at best, only 5% of irinotecan will be converted to the active 
SN-38 form by esterase activity residing primarily in the liver, albeit there are esterases in the 
tumor that can cleave irinotecan to SN-38.41-44 Its rapid catabolism in the liver results in its 
transport through the bile duct into the intestines, resulting in GI toxicity. 
To improve the bioavailability of SN-38, Gilead Sciences, Inc. developed a procedure for coupling 
SN-38 to an antibody with an average drug:antibody ratio of 7.6 that retains the antibody 
molecular integrity and specific binding.45-47 The specific linker being used with the current 
conjugate was selected from several initial candidates that were susceptible to cleavage in 
human serum at 37°C, with 50% of the SN-38 released in ~0.5 to >7.0 days.45,46 In mouse models 
bearing human tumor xenografts, one particular linker with an SN-38 release half-life of 1.0 to 
1.5 days was found to have the best therapeutic response.45 Since these initial studies were 
performed with an antibody that did not internalize readily, we believe the conjugate’s 
therapeutic activity benefits from a slow release of SN-38 from the antibody, particularly after 
it is localized in the tumor. Importantly, significant anti-tumor effects were possible at doses in 
mice that were completely non-toxic. For example, depending on the tumor cell line, significant 
therapeutic effects were observed at cumulative doses of 1 to 4 mg (~2 to 6.4 μg SN-38) of the 
conjugate given over 1 to 4 weeks, yet the maximum tolerated dose was ~60 mg of the conjugate 
given in 1 week. These results suggested the ADC had a therapeutic window of > 10:1. 
The anti-tumor activity of the hRS7-SN-38 conjugate was examined in mice bearing a variety of 
human epithelial cancer xenografts, where it was shown to have significant anti-tumor 
effects as compared to free SN-38, irinotecan, or an irrelevant IgG-SN-38 conjugate.34,47,48 As 
mentioned above, preclinical studies in mice revealed animals could tolerate as much as 60 mg 
of the conjugate (3000 mg/kg) given as 2 doses spaced 3 days apart with no evidence of weight 
loss or appreciable change in blood counts. However, there were significant changes in liver 
transaminases that were returning to normal levels 2 weeks after treatment.34 
In the phase I portion of this study (Sacituzumab Govitecan 1),36 3 subjects (2 colorectal and 1 
pancreatic cancer) were treated at the starting dose of 8 mg/kg, 2 still continuing after 6 cycles 
without toxicity while one withdrew after 3 cycles due to disease progression, not toxicity. This 
met the protocol requirement for dose escalation with 0/3 cases of dose-limiting toxicity (DLT) 
occurring during the first cycle. At 12 mg/kg, 9 subjects received treatments (3 pancreatic, 
2 triple-negative breast, 1 non-small -cell lung, 1 urinary bladder, 1 hormone-refractive 
prostate, 1 ovarian cancer). None encountered DLT, but at the next dose level of 18 mg/kg, 
2 of the 3 subjects treated (2 triple-negative breast, 1 esophageal cancer) encountered DLT 
(severe neutropenia) within the first cycle, thus exceeding the maximum tolerated dose (MTD). 
In addition, an acceptable dose level was defined as one for which ≥ 2/6 subjects tolerate a full 
21-day cycle of treatment without the need for dose delay or reduction or any ≥ Grade 3 toxicity. 
Eight of the 9 subjects treated at 12 mg/kg required dose delays and reductions during the first 
cycle suggesting that the starting dose had exceeded the maximum acceptable dose for further 
consideration. In contrast, the initial dose level of 8 mg/kg appeared acceptable with 3 additional 
subjects (2 pancreatic, 1 gastric cancer). To establish an optimal acceptable dose level, a final 
intermediate dose level of 10 mg/kg was evaluated and considered to be active with an 
acceptable safety profile. At this dose level severe (Grade 3 or higher) toxicities have primarily 

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included manageable neutropenia, diarrhea and febrile neutropenia. Adverse events (AEs) of 
all causalities (all grades and Grade ≥3) are shown in Table 2 and Table 3. 
 
Table 2: Adverse Events Leading to Treatment Interruption in >2% of Patients 
8 mg/kg 
10 mg/kg 
12 
mg/kg 
18 mg/kg 
Any Dose 
Patients, n (%) 
81 (100) 
327 (100) 
9 (100) 
3 (100) 
420 (100) 
Patients with AEs leading 
to treatment interruption 
43 (53.1) 
152 (46.5) 
7 (77.8) 
3 (100) 
205 (48.8) 
Blood and lymphatic 
system disorders 
20 (24.7) 
70 (21.4) 
7 (77.8) 
2 (66.7) 
99 (23.6) 
Neutropenia 
17 (21.0) 
61 (18.7) 
7 (77.8) 
2 (66.7) 
87 (20.7) 
Anemia 
5 (6.2) 
13 (4.0) 
0 
0 
18 (4.3) 
Investigations 
5 (6.2) 
47 (14.4) 
0 
0 
52 (12.4) 
Neutrophil count decreased 
3 (3.7) 
35 (10.7) 
0 
0 
38 (9.0) 
WBC count decreased 
4 (4.9) 
12 (3.7) 
0 
0 
16 (3.8) 
Gastrointestinal disorders 
6 (7.4) 
28 (8.6) 
0 
2 (66.7) 
36 (8.6) 
Nausea 
3 (3.7) 
10 (3.1) 
0 
1 (33.3) 
14 (3.3) 
Vomiting 
2 (2.5) 
9 (2.8) 
0 
1 (33.3) 
12 (2.9) 
General disorders and 
administration site 
conditions 
12 (14.8) 
22 (6.7) 
1 (11.1) 
1 (33.3) 
36 (8.6) 
Fatigue 
5 (6.2) 
10 (3.1) 
1 (11.1) 
0 
16 (3.8) 
Pyrexia 
5 (6.2) 
4 (1.2) 
0 
0 
9 (2.1) 
Infections and infestations 
7 (8.6) 
22 (6.7) 
29 (6.9) 
Respiratory, thoracic and 
mediastinal disorders 
4 (4.9) 
8 (2.4) 
0 
0 
12 (2.9) 
Metabolism and nutrition 
disorders 
2 (2.5) 
8 (2.4) 
0 
0 
10 (2.4) 
 
Table 3: Adverse Events of ≥ Grade 3 Occurring in >5% of Patients 
Any grade 
≥Grade 3 
Grade 4 
Grade 5 
Patients, n (%) 
420 (100.0) 
Patients with at least one AE 
419 (99.8) 
227 (54.0) 
70 (16.7) 
20 (4.8) 
Gastrointestinal disorders 
382 (91.0) 
87 (20.7) 
0 
0 
Nausea 
283 (67.4) 
22 (5.2) 
0 
0 
Diarrhea 
261 (62.1) 
37 (8.8) 
0 
0 

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General disorders and administration. 
site conditions 
316 (75.2) 
54 (12.9) 
0 
5 (1.2) 
Fatigue 
224 (53.3) 
41 (9.8) 
0 
0 
Blood and lymphatic system disorders 
277 (66.0) 
109 (26.0) 
49 (11.7) 
0 
Anemia 
171 (40.7) 
47 (11.2) 
1 (0.2) 
0 
Neutropenia 
171 (40.7) 
75 (17.9) 
43 (10.2) 
0 
Febrile neutropenia 
25 (6.0) 
18 (4.3) 
5 (1.2) 
0 
Metabolism and nutrition disorders 
266 (63.3) 
76 (18.1) 
8 (1.9) 
0 
Hypophosphatemia 
51 (12.1) 
22 (5.2) 
1 (0.2) 
0 
Respiratory, thoracic and mediastinal 
disorders 
210 (50.0) 
23 (5.5) 
6 (1.4) 
7 (1.7) 
Investigations 
204 (48.6) 
71 (16.9) 
21 (5.0) 
0 
Neutrophil count decreased 
77 (18.3) 
41 (9.8) 
13 (3.1) 
0 
WBC count decreased 
62 (14.8) 
25 (6.0) 
9 (2.1) 
0 
Infections and infestations 
179 (42.6) 
38 (9.0) 
3 (0.7) 
2 (0.5) 
 
Responses have been observed in subjects with triple-negative breast cancer (TNBC), small-cell 
lung cancer, non-small- cell lung cancer, esophageal cancer, urinary bladder, and colorectal 
cancer.37-40,49 Disease stabilization has been observed in many subjects. Since the initial results 
over 465 subjects (including, 32 colorectal, 147 TNBC, 60 SCLC, 46 urothelial cancer, 55 non-small 
cell lung cancer (NSCLC), and 52 advanced/metastatic breast cancer (Non-TNBC), have been 
treated with Sacituzumab Govitecan, the majority at 10mg/kg given on days 1 and 8 in a 21-day 
cycle. 
While Sacituzumab Govitecan has not been combined with ARSIs in prior studies, fatigue is the 
only anticipated overlapping toxicity between these classes of agents. ARSIs have been combined 
with chemotherapy agents in other studies and found to be feasible. 69,70,71 
Subjects who started treatment prior to IRB approval of amendment 5 will continue at their 
current dose with the ability to dose reduce per protocol. 
1.4 
New Biomarkers in Prostate Cancer 
1.4.1 
Need for predictive biomarkers in the second-line CRPC setting 
Abiraterone and enzalutamide are established standards of care for pre- and post- 
chemotherapy treated CRPC, as well as abiraterone in metastatic hormone sensitive 
prostate cancer. Both target the AR signaling axis, indicating the importance of this 
pathway in the pathogenesis of prostate cancer. While response rates have been 
observed when patients initially treated with one of these agents crossover to receive the 
contralateral therapy, these response rates and duration of response are significantly 
lower than untreated men. The optimal sequence of administration of abiraterone and 
enzalutamide to maximize patient benefit has not been established and it is appropriate 

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to use either agent in the first-line setting at this time as both have similarly high response 
rates. It remains unknown if there is a select group of patients that would benefit from 
continued targeting of the AR signaling axis or transition to a therapy with a distinct 
mechanism of action. All of these scenarios highlight the choice of agent following 
progression on the first “next-generation hormonal treatment” as a key decision point in 
management. 
Mechanisms of resistance to AR-targeted therapy 
Possible mechanisms of resistance to both abiraterone and enzalutamide and to each one 
individually have been postulated. In laboratory models and translational studies 
resistance to these agents has been associated with genomic alterations in the AR and 
expression of AR variants lacking the ligand binding domain. The F876L somatic point 
mutation of the AR gene converts enzalutamide into a functional agonist of the mutated 
AR.50 Early work has identified the presence of this mutation in clinical samples and 
confirmed its presence as a mechanism of acquired resistance to enzalutamide. Another 
mechanism identified in tumor models with acquired resistance to enzalutamide is 
upregulation of the glucocorticoid receptor which in turn acquires the ability to activate 
a selected series of AR responsive genes, co-opting AR signaling.51 In this model, 
dexamethasone conferred resistance to enzalutamide, a finding validated clinically in a 
post hoc analysis of the phase III AFFIRM trial which showed concomitant use of 
glucocorticoids was associated with inferior survival.52 Other mechanisms of resistance 
include AR splice variants,53,54 truncated forms of the AR that lack a LBD and are 
constitutively activated to regulate a similar (but not identical) set of genes to those 
regulated by full-length AR protein. They are more prevalent in CRPC than in hormone- 
naïve tumors and both preclinical and clinical data have identified them as possible 
mechanisms of resistance to abiraterone and enzalutamide.12,55,56 The selection or 
emergence of neuroendocrine-like cells, termed neuroendocrine differentiation, may 
also contribute to treatment resistance.57 Other alterations that may confer resistance 
include loss of reciprocal feedback inhibition between the PI3K/mTOR pathway, 
mutation, deletion or epigenetic silencing of PTEN, or activating mutations of PI3KCA or 
AKT.58 
Given these findings, biopsies of metastatic sites are now considered standard of care 
interventions for patients who have progressed on treatment with abiraterone or 
enzalutamide.10 Recent studies have identified other genomic and transcriptomic 
alterations, including AR gene rearrangements and novel splice variants that identify 
distinct mechanisms of resistance.11 
Correlative circulating biomarker assays 
All of the aforementioned mechanisms of resistance to novel AR targeted therapies point 
to the need to search for predictive biomarkers of response/resistance to these agents. 
The practice of “Precision Medicine” requires the ability to characterize the changing 
biology of the disease in an individual as it evolves over time. This biology is a reflection 
of intrinsic properties of the tumor and the prior treatment(s) to which it has been 
exposed. While some studies suggest that a core set of mutations in primary and 
metastatic disease are shared, it is now recognized that separate tumor foci with the same 

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ancestral event (e.g., ERG fusion) can have subclonal secondary events, which suggests 
continued subclonal acquisition of rearrangements.59 
Blood based biomarkers including CTCs and ctDNA may overcome this limitation and 
serve as a source of tumor material that represents multiple metastatic sites and can be 
easily accessed non- invasively through peripheral blood sampling thereby giving real- 
time insight to the biologic profile of a tumor at the time treatment is considered. Such 
information can be used to assess baseline disease characteristics and heterogeneity as 
well as detecting and following the emergence of treatment resistant cell populations. 
They may also obviate the need for invasive and costly metastatic biopsies. 
1.4.2 
Circulating tumor cells 
CTCs disseminate from multiple metastatic sites and may provide an ideal source of tumor 
for real time molecular information about a patient’s disease that can be accessed easily 
by non-invasive means through peripheral blood sampling. Numerous CTC isolation and 
capture techniques have been reported, but only one assay, CellSearch (Menarini Silicon 
Biosystems) is analytically validated and FDA-cleared.60 The assay uses an epithelial cell 
adhesion molecule (EpCAM) capture method and reports only one CTC subtype - the 
number of cells that stain for cytokeratin (CK6),24,56 display a nucleus (40, 6 diamidino 2 
phenylindole [DAPI]) which lacks the white blood cell marker CD45. The results provide 
prognostic information pre- and post-therapy, but are limited by a low sensitivity of 
detection (5 or more cells are detected in only 1%, 55% and 40% of localized, metastatic 
castration-sensitive, and metastatic CRPC, respectively).61-63 
The VERSA (Vertical Exclusion-based Rare Sample Analysis) platform employs a 
microfluidic technology that performs a highly efficient (up to 90% of tumor cells) and 
highly sensitive CTC capture (as low as one tumor cell per 20mL of blood) that integrates 
downstream techniques for intracellular staining of CTCs and nucleic acid extraction.11,64 
The VERSA incorporates a dialysis membrane for in-chip fixation, permeabilization, and 
intracellular staining within a single cell with essentially no cell loss as there is no direct 
sample manipulation. This technology is now being used to purify CTCs from patients with 
prostate cancer followed by quantitative immunocytochemistry and subcellular 
localization of the AR in CTCs. The VERSA platform further performs total nucleic acid 
extraction for both genomic and gene expression studies on the same sample, from as 
few as 1-10 cells. Gene expression analysis for multiple AR variants, AR pathway targets 
and neuroendocrine markers can be performed. 
1.4.3 
Circulating tumor DNA (ctDNA) 
Non-invasive detection of tumor genotype offers an attractive strategy to monitor 
response to a targeted therapy, query for resistance mechanisms, and evaluate for 
residual disease or recurrence after definitive therapy. Recent studies suggest that highly 
sensitive genotyping assays can detect mutations in cell-free plasma DNA (cfDNA) from 
cancer patients, potentially representing the biology of a patient’s cancer. The underlying 
concept is that genes from malignant cells dissipate or “leak” into the circulation, where 
they can be detected and quantified by quantitative and sensitive PCR techniques. This 
central concept has been convincingly validated in preliminary studies and an analytically 
valid, clinically feasible, noninvasive assay has been developed for quantitative 

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measurement of cfDNA genotypes using droplet digital PCR (ddPCR).65 This technology 
emulsifies input DNA into ~20,000 droplets so that the proportion carrying mutant versus 
wild type alleles can be counted using flow cytometry. Unlike prior sensitive genotyping 
assays, ddPCR is quantitative and so has allowed the development of assays with nearly 
100% specificity and 70% sensitivity in patients with advanced progressive NSCLC and 
melanoma. The method has been used to serially analyze cfDNA from EGFR mutant NSCLC 
patients treated with the EGFR kinase inhibitor erlotinib. Prior to treatment, the EGFR 
activating mutation can be detected from cfDNA and decreases following erlotinib 
therapy. However, over time both the activating and the drug resistance T790M mutation 
emerge and can be detected from cfDNA. Data from the lung cancer literature show that 
the EGFR T790M mutation (which confers resistance to EGFR inhibitors erlotinib or 
gefitinib) is likely present as a subclone of cells at baseline in many patients and estimate 
that it only confers resistance when present in ≥3.2% of cancer cells.66 Likewise, the 
emergence of the AR 876L mutation can be detected with these approaches in the context 
of acquired resistance to enzalutamide.67 New assays continue to be developed for 
specific alterations in prostate cancer. 
2. 
OBJECTIVES 
2.1 
Primary Objective 
• 
To determine the proportion of subjects who have ≥50% PSA decline at or within 9 weeks of 
starting treatment with Sacituzumab Govitecan. 
• 
To determine the 6-month rPFS rate 
2.2 
Secondary Objectives 
• 
To determine median rPFS 
• 
To determine radiologic response rate 
• 
To determine OS 
• 
To determine safety and tolerability 
2.3 
Exploratory Objective 
To associate predictive biomarkers with clinical outcomes to Sacituzumab Govitecan in CRPC subjects who 
have progressed while on enzalutamide, apalutamide, or abiraterone. 
3. 
STUDY POPULATION 
Subjects with CRPC who have progressed while on second generation AR-directed therapy (e.g., 
enzalutamide, darolutamide, apalutamide and/or abiraterone), in either the hormone sensitive 
or CRPC setting, will be considered. Subjects who have progressed while on therapy with 
combination enzalutamide/abiraterone or prior ARN-509/abiraterone as part of ongoing clinical 
trials are allowed. Subjects will continue single agent ARSI and Sacituzumab Govitecan will be 
added to the treatment regimen as part of this clinical trial protocol. Subjects who started 
treatment prior to IRB approval of amendment 5 will continue on Sacituzumab Govitecan single 
therapy. 

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3.1 
Inclusion Criteria 
To be included in this study, subjects should complete all screening procedures and meet all of 
the following criteria: 
3.1.1 
Documented histological or cytological evidence of adenocarcinoma of the prostate 
3.1.2 
Documented metastatic disease on bone scan and/or CT scans 
3.1.3 
Currently receiving enzalutamide, darolutamide, apalutamide and/or abiraterone. 
Subjects who have received combination enzalutamide/abiraterone or combination 
apalutamide/abiraterone as part of clinical trials are allowed but will need to be receiving 
only a single agent ARSI at the time of study enrollment. Subjects who have received any 
other therapeutic investigational product directed towards the AR or androgen 
biosynthesis are allowed. Prior treatment with first-generation AR antagonists (i.e., 
bicalutamide, nilutamide, flutamide) before second generation AR-directed therapy is 
allowed. 
3.1.4 
Demonstrated disease progression while on enzalutamide, darolutamide, apalutamide 
and/or abiraterone. Progressive disease is defined by one or more of the following: 
• 
A rise in PSA on two successive determinations at least one week apart and PSA 
level ≥2 ng/mL 
• 
Soft-tissue progression defined by RECIST 1.1 
• 
Bone disease progression defined by PCWG2 with ≥2 new lesions on bone scan 
3.1.5 
A minimum serum PSA level of ≥2 ng/mL that is rising based on the PCWG2 criteria 
3.1.6 
≥18 y ears of age 
3.1.7 
Castrate levels of testosterone (<50 ng/dL [1.74 nmol/L]) 
3.1.8 
Undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 
months prior to study treatment start. Subjects on LHRH agonists/antagonists must 
remain on these agents for the duration of the study 
3.1.9 
ECOG Performance Status of 0-1 (Appendix A) 
3.1.10 Normal organ function with acceptable initial laboratory values within 30 days of study 
treatment start: 
 
WBC 
≥3000/μl 
ANC 
≥1000/μl 
Platelet count 
≥100,000/μl 
HGB 
≥9 g/dL 
 
3.1.11 Adequate hepatic function as evidenced by AST/ALT levels <3X the ULN and bilirubin 
levels of <2.0 mg/dl. 
3.1.12 Adequate renal function as evidenced by serum creatinine of <2.0 mg/dL 
3.1.13 Able to provide written informed consent, or have a legal representative provide written 
informed consent 
3.1.14 Subjects must have a previously-acquired biopsy from a metastatic site available 

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3.1.15 Subjects must be willing and able (in the opinion of the treating physician) to undergo one 
research biopsy for the investigational component of this study 
3.1.16 Subjects who have partners of child-bearing potential must be willing to use at least two 
forms of effective birth control (one form must be a barrier method) during the treatment 
period and for 90 days after last dose of Sacituzumab Govitecan . Subjects must also agree 
to not donate sperm through 90 days following the last dose of Sacituzumab Govitecan. 
3.2 
Exclusion Criteria 
3.2.1 
Received prior cytotoxic chemotherapy such as docetaxel, cabazitaxel or platinum 
chemotherapy for metastatic prostate cancer, castration sensitive or castration resistant, 
within two years prior to study entry. Neoadjuvant chemotherapy is allowed. 
3.2.2 
Completed sipuleucel-T (Provenge ®) treatment within 30 days of study treatment start. 
3.2.3 
Received any therapeutic investigational agent within 2 weeks of study treatment start. 
3.2.4 
Received palliative radiotherapy within 4 weeks of study treatment start. 
3.2.5 
Received herbal products or alternative therapies that may decrease PSA levels or that 
may have hormonal anti-prostate cancer activity (e.g., saw palmetto, PC-SPES, PC-HOPE, 
St. John’s wort, selenium supplements, grape seed extract, etc.) within 4 weeks of study 
treatment start or plans to initiate treatment with these products/alternative therapies 
during the entire duration of the study. 
3.2.6 
Active CNS metastases from prostate cancer. Subjects with treated epidural disease are 
eligible to enroll. Subjects with treated brain metastases can be included as long as >4 
weeks have elapsed since last treatment (radiotherapy or surgery) for brain metastases, 
the subject is neurologically and radiographically stable, and is not receiving 
corticosteroids for brain metastases. Subjects with untreated brain metastases are 
excluded. Brain imaging (CT or MRI) is not required at baseline if brain metastases are not 
clinically suspected. 
3.2.7 
A history within the last 3 years of another invasive malignancy (excluding non-melanoma 
skin cancer). 
3.2.8 
A QTcF interval of >470 msec on the initial Screening ECG; if the Screening ECG QTcF 
interval is >470 msec, then it may be repeated two more times, and if the mean QTcF of 
the 3 ECGs is ≤470 msec, the subject may be enrolled. 
3.2.9 
A history of clinically significant cardiac arrhythmias including ventricular tachycardia, 
ventricular fibrillation, torsades de pointes and second degree or third degree 
atrioventricular heart block without a permanent pacemaker in place. Subjects with 
resolved or rate-controlled atrial fibrillation/atrial flutter are allowed. 
3.2.10 NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction/acute 
coronary syndrome within the preceding 6 months. 
3.2.11 Diabetes mellitus with more than 2 episodes of diabetic ketoacidosis in the 12 months 
preceding study treatment start. 

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3.2.12 Inadequately controlled hypertension (defined as blood pressure >150mmHg systolic 
and/or >100 mmHg diastolic despite antihypertensive medication) or any history of 
hypertensive crisis or hypertensive encephalopathy. 
3.2.13 History of loss of consciousness or transient ischemic attack within 12 months before 
study treatment start. 
3.2.14 Known active HIV, Hepatitis B, or Hepatitis C infections. 
3.2.15 Any other medical, psychiatric, or social condition, including substance abuse, which in 
the opinion of the Investigator would preclude safe participation in the study. 
4. 
ENROLLMENT PLAN 
Enrolled Subjects must have CRPC and have demonstrated disease progression (objective or PSA) 
while on second generation AR-directed therapy and have rising PSA levels immediately prior to 
enrollment based upon the criteria as defined by the PCWG2. PSA values must exhibit a rise on 
two occasions of at least a week apart, over a baseline value, with the final value ≥2 ng/ml. A 
graphical depiction of this is shown in Figure 1 (PCWG2 Rising PSA Study Eligibility Criteria).68 
Prior exposure and sensitivity to AR-directed therapy will be recorded and subjects will be 
considered to have responded (i.e., were sensitive) to the prior agent if there was a ≥50% PSA 
decline from baseline. Patients will continue on an ARSI and Sacituzumab Govitecan will be added 
to the treatment regimen as described below. Treatment with Sacituzumab Govitecan can 
continue until disease progression, unacceptable toxicity, initiation of alternative therapy or 
withdrawal of consent. 

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Figure 1. PCWG2 rising PSA study eligibility criteria 
The reference value (#1) is the last PSA measured before increases are documented, with subsequent 
values obtained a minimum of 1 week apart. If the PSA at time point 3 (value #3A) is greater than that at 
point 2, then eligibility has been met. If the PSA is not greater than point 2 (value #3B), but value #4 is, 
the subject is eligible assuming that other criteria are met. Values 3A or #4 must be 2 ng/mL or higher.68 
 
 
4.1 
Number of Subjects 
It is planned that up to 55 subjects will be enrolled. 
4.2 
Eligibility Confirmation 
Confirmation of eligibility will be completed centrally by the Prostate Cancer Clinical Trials 
Consortium (PCCTC) prior to study treatment start. A record of subjects who fail to meet eligibility 
criteria (i.e., screen failures) will be maintained. A complete, signed informed consent and HIPAA 
authorization are required as part of eligibility confirmation. All subjects must sign an IRB- 
approved informed consent prior to starting any protocol-specific procedures; however, 
evaluations performed as part of routine care prior to informed consent can be used for screening 
and eligibility confirmation. 
5. 
STUDY PROCEDURES 
This is an open-label, multicenter, single-arm phase II study in subjects with metastatic CRPC who 
have progressed while on second generation AR-directed therapy. Subjects enrolled in this study 
will receive Sacituzumab Govitecan as treatment for CRPC and continue treatment with an ARSI. 
Subjects who started treatment prior to IRB approval of amendment 5 will continue on 
Sacituzumab Govitecan single therapy. 
The following assessments and procedures will occur during the study. A schedule of 
assessments is provided in Appendix B. 

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5.1 
Screening Activities 
Each subject will undergo a screening period of up to 30 days following the provision of signed 
informed consent. Screening will include procedures as outlined in the schedule of procedures in 
Appendix B. 
5.1.1 
Informed consent and research/HIPAA authorization 
No study procedure or alteration of patient care will be undertaken until informed 
consent has been obtained from the patient or legal representative. However, 
evaluations performed as part of routine care prior to informed consent can be used for 
screening and eligibility confirmation. The Investigator will explain the nature and scope 
of the study, potential risks and benefits of participation, and answer questions for the 
patient and/or legally authorized representative. If the patient agrees to participate, the 
informed consent form will be signed, dated, and witnessed, with a copy given to the 
subject. 
5.2 
Study Procedures 
5.2.1 
Demographics and Medical history 
A careful medical history, with particular attention to the subject’s history of prostate 
cancer and prior therapy for prostate cancer, will be obtained during Screening. 
Treatment history will include treatment response and time to progression for last 
therapy regimen. Other pertinent aspects of the subject’s medical history should also be 
obtained. Medical history that does not impact a subject’s prostate cancer, or their 
expected tolerance of Sacituzumab Govitecan need not be collected. Previous use of anti- 
androgens and anti-hormonal medications for treatment of prostate cancer should also 
be obtained. For subjects on this study, the duration of treatment with abiraterone or 
enzalutamide as well as responses to these therapies (clinical, radiographic and PSA 
response) should also be recorded. Additionally, it should be noted if the therapies were 
co-administered with prednisone or other steroids. 
5.2.2 
Concomitant Medications 
Concomitant medications will be recorded from the time of informed consent through 
the latter of the end of treatment or resolution of any adverse ongoing at the end of 
treatment. 
5.2.3 
Physical Examination 
A comprehensive physical exam should be performed at Screening and at the End of 
Treatment Visit. Physical exams conducted at other visits can be brief and targeted on 
areas known to be abnormal, or driven by clinical findings and/or subject complaints 
5.2.4 
Vital Signs 
Vital signs will consist of blood pressure, pulse, and body temperature. On treatment 
days, vital signs (blood pressure, pulse) will be collected prior to first infusion and every 
15 minutes for the first hour then every 30 minutes until completing IV administration, at 
completion, and then additionally 30 minutes later. In absence of significant changes, 
frequency may be reduced with subsequent doses to prior to infusion, at 30 minutes, and 
then at completion. All time points may be collected ± 5 minutes. 
5.2.5 
Weight and Height 

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Weight and height will be obtained with the subject clothed, but without shoes. Height 
will only be obtained at Screening. Weight will be conducted at each treatment visit prior 
to study drug administration. Use weight on day 1 of each cycle to determine dose. Dose 
must be recalculated on day 8 if weight changes (increases or decreases) by > 10% from 
day 1 weight. Round each dose to nearest one milligram. 
5.2.6 
ECOG Performance Score 
ECOG performance status assessments (Appendix A) are required to assess subject 
functional status for study eligibility purposes and will be performed throughout the study 
according to the schedule of procedures. 
5.2.7 
ECG 
A 12-lead ECG will be obtained at screening and at the end of study visit. It is not necessary 
to do ECGs 5 minutes apart. Additional unscheduled 12-lead ECG may be conducted when 
necessary at the investigator’s discretion. 
5.3 
Determination of Extent of Metastatic Disease 
All subjects will undergo an extent of disease evaluation consisting of bone scintigraphy, CT of the 
chest, CT of the abdomen and pelvis, and other regions of known/suspected involvement, at 
Screening unless already conducted within 30 days of Cycle 1, Day 1. CT scans should be 
performed with contrast unless contraindicated. MRI abdomen and pelvis with contrast may be 
done in situations where a CT with contrast is equivocal or contraindicated. A non-contrast chest 
CT should be done for subjects requiring an MRI of the abdomen and pelvis. 
Subjects will undergo repeat evaluations of their extent of disease every 9 weeks (± 7 days) if they 
remain progression- free on study. Imaging modality should remain consistent by lesion 
throughout the study. 
5.4 
Laboratory Evaluations 
On treatment days, blood samples should be collected prior to infusion. Laboratory tests will be 
performed by local labs and will include: 
5.4.1 
CBC 
A CBC will consist of determinations of hemoglobin (HGB), hematocrit (HCT), white blood 
cells (WBC), red blood cells (RBC), neutrophils, lymphocytes, monocytes, eosinophils, 
basophils, and platelet count. Absolute values are preferred. 
5.4.2 
Coagulation factors 
Partial thromboplastin time (PTT) and prothrombin time (PT) or international normalized 
ratio (INR) will be obtained according to the schedule of procedures and at any other visit 
where clinically indicated. 
5.4.3 
Comprehensive metabolic panel (CMP) 
A CMP will consist of determinations of sodium, potassium, chloride, bicarbonate, blood 
urea nitrogen (BUN), glucose, creatinine, aspartate transaminase (AST), alanine 
transaminase (ALT), alkaline phosphatase, lactate dehydrogenase, total bilirubin, total 
protein, albumin, serum calcium, magnesium, and phosphorous. 
5.4.4 
Urinalysis 

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Urinalysis will include pH, specific gravity, and hemoglobin, glucose, ketones, and protein 
by dipstick, with microscopic exam if any of the dipstick analytes are 2+ or higher. 
5.4.5 
PSA 
Serum PSA will be obtained per the schedule of procedures. At Screening, the PSA must 
be increasing in conformance with the requirements of the PCWG2 criteria (Appendix E). 
5.4.6 
Testosterone 
Serum testosterone will be measured to confirm castrate levels <50 ng/dL. 
5.5 
Correlative biomarker studies 
Subjects will have correlative biomarker studies performed at baseline, serially throughout 
treatment per study schedule and again at time of disease progression in subjects who initially 
respond. The specific aims of these studies are to: 
1) Identify predictive biomarkers of response/resistance to Sacituzumab Govitecan. 
2) Assess if early changes in circulating biomarkers can identify impending disease 
progression in advance of traditional measures such as PSA, radiologic measurements and 
clinical symptoms. 
3) Identify mechanisms of acquired resistance to Sacituzumab Govitecan by re-biopsy of 
tumor tissue and circulating biomarkers prior to cycle 4. 
5.5.1 
Tumor Biopsy 
Subjects must have an available tumor (including archival material) from a biopsy of a 
metastatic site performed as standard of care to enroll. No specific timeframe parameters 
will be applied to the archival material as long as the material is from a metastatic site. 
Normal tissue (buffy coat of blood) will be collected. The buffy coat and tumor will be sent 
for DNA sequencing ± RNA expression analysis. The exact methodology for DNA 
sequencing and RNA expression analysis will be decided at the time of sample analysis, 
depending on methodologies available at the time because there are continued 
developments in this field with new technologies and sequencing panels emerging 
regularly. Biopsy of a soft tissue lesion is preferable over a bone lesion if safe and feasible; 
however, either will be accepted to meet the enrollment and on-study biopsy 
requirements. A new biopsy will be performed on Cycle 3 Day 15 (± 7 days) for DNA 
sequencing and RNA expression analysis. This biopsy should preferably be obtained from 
the same site as the pre-treatment biopsy. This will provide a unique opportunity to 
investigate the potential mechanisms of response and resistance to Sacituzumab 
Govitecan. Biopsy samples will be sent for processing and analysis to Dr. Scott Dehm at 
the University of Minnesota. 
5.5.2 
CTCs 
Blood will be collected for analysis of CTCs and plasma factors that may include ctDNA 
and exosomes. Blood sample will be shipped to the University of Wisconsin for analysis 
and comparison of Trop-2 and EpCAM CTCs. Evaluation of AR splice variants and 
neuroendocrine signatures will be performed in CTCs. Plasma will be collected and stored 
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5.6 
End of Treatment Evaluation or Unscheduled/Early Termination Visit 
Procedures listed in the study schedule will be conducted 30 days (+7 days) after the last dose of 
study drug or in the event of premature study termination. 
The End of Treatment procedures listed in the study schedule will also be performed at the time 
of progression or initiation of another treatment if the subject discontinued study treatment for 
other reasons. 
5.7 
Long-Term Follow-Up 
After completing the end of treatment evaluation, follow-up continues for subjects who have not 
progressed with assessments including PSA, bone scan and/or CT scans performed every 3 
months or per standard of care for up to 2 years from initiation of study therapy or until 
progression of disease or initiation of other treatment. Modalities of disease assessment at 
baseline will be used at subsequent response evaluations for determination of response and/or 
disease progression. 
Adverse events and concomitant medications reported at any follow-up visits will include 
outcome of any ongoing unresolved events, new events attributed to the study treatment, 
deaths, hospitalizations, and infectious episodes requiring prescription or IV anti-infectives or GI 
toxicity. Follow-up for treatment related toxicities which may include physical exam, CBC and 
chemistries will be required till resolution or stabilization of the toxicity. 
5.8 
Criteria for Removal from Protocol Treatment 
Every effort should be made to keep subjects on study drug for a minimum of 9 weeks (i.e., 3 
cycles) unless withdrawal of informed consent, the presence of significant toxicity, clear 
progression of neoplastic disease, or any other reason for the removal from study as outlined in 
this section. Per the PCWG2 guidelines, “in the absence of clinically-compelling indicators of 
disease progression, early changes (within 9 weeks) in indicators such as serum PSA, patient- 
reported pain, and radionuclide bone scan should be ignored”. With respect to bone scan 
changes, 72% of the apparent disease progressions, in the abiraterone acetate plus prednisone 
vs. placebo plus prednisone registration trial, proved to be responders and were able to continue 
therapy. In contrast, unequivocal signs of disease progression such as spinal cord compression or 
pain requiring a change in therapy would require discontinuation of Sacituzumab Govitecan prior 
to 9 weeks (i.e., before completing Cycle 3). 
Subjects who require palliative radiotherapy for focal symptom relief may remain on study as long 
as the treating investigator feels they are deriving benefit from Sacituzumab Govitecan 2 and the 
radiotherapy is not to a target or non-target lesion recorded at baseline. 
Subjects may be removed from protocol treatment under the following conditions: 
 
• 
First documentation of progressive disease or symptomatic deterioration indicating 
treatment failure. 
o Discontinuation is subject to the goal of not removing subjects prior to completing 9 
weeks of treatment especially for the lone reason of rising PSA. Subjects with rising PSA 
may continue on study beyond Cycle 3 at the discretion of the investigator. 

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o Subjects who want to continue treatment after radiological documentation of 
progressive disease should notify the physician who will obtain Sponsor approval before 
treatment continuation. 
• 
Unacceptable toxicity, or any AE, which in the opinion of the investigator precludes further 
participation in the study. 
• 
Treatment delay for any reason > 3 weeks (Treatment delays of up to 3 weeks will be 
allowed at the investigator’s discretion). If treatment delay is due other than to treatment- 
related toxicity and a patient is receiving clinical benefit, the subject may be allowed to 
remain on study after > 3 weeks treatment delay after first obtaining approval from the 
Sponsor Investigator. The maximum treatment delay allowed even when the subject is 
receiving clinical benefit is no more than 6 weeks. 
• 
Development of an intercurrent medical condition and need for prohibited concomitant 
treatment that precludes further participation in the study. 
• 
Subject failure to follow study requirements. 
• 
Physician decision: the investigator removes the patient from the study in the best interest of 
the patient. 
• 
The subject is lost to follow-up. 
• 
Study termination by the Sponsor. 
• 
Use of prohibited concomitant medications (defined in Section 6.5.1). 
• 
The subject may withdraw from the study at any time for any reason. 
 
If a subject voluntarily withdraws from the study, attempts should be made to contact the subject 
to determine the reason(s) for discontinuation. All procedures and evaluations required by the 
End of Treatment Visit should be completed in the event of early withdrawal, regardless of reason. 
All subjects who discontinue the study due to an AE must be followed until resolution or 
stabilization of the AE. 
6. 
INVESTIGATIONAL MEDICINAL PRODUCT AND STUDY TREATMENT 
6.1 
Sacituzumab Govitecan Formulation 
hRS7 is a CDR-grafted, humanized monoclonal IgG1 anti-Trop-2 antibody. The antibody is 
prepared using cell culture methods by Gilead Sciences, Inc., (Morris Plains, NJ) in accordance 
with FDA guidelines for the manufacture and testing of monoclonal antibody products for human 
use. SN-38 (7-ethyl-10-hydroxy-camptothecin) is a small molecule and the active metabolite of 
the chemotherapeutic agent irinotecan. 
Sacituzumab Govitecan is an antibody drug-conjugate prepared by Gilead Sciences, Inc., (Morris 
Plains, NJ) at an SN-38 to hRS7 ratio of ~7:1 (mol:mol). The conjugation uses a spacer containing 
a cleavable-carbonate bond to attach SN-38 to reactive cysteine thiols present on the hRS7 
antibody. For clinical use, 10 mg/mL Sacituzumab Govitecan is formulated in 25 mM MES, pH 6.5 
together with the other excipients (25 mM trehalose, 0.01% Polysorbate 80), which is 
then lyophilized. Glass vials containing 200 mg Sacituzumab Govitecan as a sterile, non- 
pyrogenic, lyophilized powder are to be stored under refrigerated conditions (2-8°C) until used. 
Each vial is labeled “For Investigational Use Only,” and identified by study drug name, lot 
number, and dose. Since the formulated drug product contains no preservative, vials should be 
used only once. 

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6.2 
Sacituzumab Govitecan Packaging and Storage 
All vials of study drug must be stored under refrigeration (monitored at 2-8°C) in a locked room 
that can be accessed only by the pharmacist, the study Investigator, or another duly designated 
person. The study medications must not be used outside of the context of this protocol. Under 
no circumstances should the Investigator or other site personnel supply study drug to other 
Investigators, subjects, or clinics, or allow supplies to be used other than directed by this protocol 
without prior authorization from Gilead Sciences, Inc.. 
6.3 
Sacituzumab Govitecan Preparation and Administration 
For subject dose preparation, Sacituzumab Govitecan is to be reconstituted with normal saline 
for use, and diluted immediately into infusion bags. Sacituzumab Govitecan is photosensitive and 
should be protected from light during storage and use per guidance provided below. 
Appropriate use of aseptic technique should be employed in preparing the dose. Allow the 
Sacituzumab Govitecan vials to warm to room temperature to allow faster dissolution. The 200mg 
lyophilized powder in each vial should only be reconstituted using 20ml 0.9% sterile sodium 
chloride (normal saline). The reconstituted solution should be gently shaken and allowed to 
dissolve for up to 15 minutes. Calculate the prescribed dose in mg based on the subject’s body 
weight at the beginning of EACH cycle, or more frequently if the subject experiences a weight 
change (increase or decrease) >10% at day 8 of the cycle. The appropriate calculated amount 
should then be withdrawn from the supplied vials of study medication. 21-gauge needle use is 
recommended. Inject the solution into a glass or plastic infusional container slowly to minimize 
foaming and do not shake the contents. Adjust the volume in the infusional container as needed 
with normal saline to obtain a concentration of 1.1-3.4 mg/mL (total volume should not exceed 
500 mL). Only normal saline should be used since the stability of the reconstituted product has 
not been determined with other infusion base solutions. A sample drug preparation chart for a 
70-kg subject is provided in Table 4 with 200 mg/vials, and 250 mL bags of normal saline as the 
infusion container. Initiate the infusion within 1 hour of reconstitution and dilution. If the infusion 
is delayed beyond 1 hour, refrigerate at 2-8C. If refrigerated, allow the diluted solution to come 
to room temperature prior to administration. If infusion does not begin within 4 hours after 
reconstitution/dilution, dispose of the original preparation and prepare a new infusion bag by 
reconstitution and dilution from new vials. Discard any unused portion in the vial. The product 
does not contain a preservative. 
 
Table 2. Sacituzumab Govitecan Preparation for 10 mg/kg Dosing (Assumes 70- 
kg Subject). 
Total Dose Needed 
700 mg 
(200 mg/vial) 
Vials Required 
4 
Volume of saline to be used for reconstitution 
20 mL 
Volume after reconstitution of each vial with USP saline 
80 mL 
Volume Withdrawn for Scheduled Dose 
70 mL 
Dilute with Normal Saline. 
180 mL 
Total Volume Dispensed 
250 mL 
Final Concentration (mg/mL) 
2.8 

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6.3.1 
Sacituzumab Govitecan drug administration 
Subjects will take Sacituzumab Govitecan at their assigned dose on days 1 and 8 in a 21- 
day cycle. The Schedule of Assessments for the various segments of the study is detailed 
in Appendix B. 
Efficacy of Sacituzumab Govitecan will be determined according to the PCWG2 criteria 
(Appendix E) and response to Sacituzumab Govitecan will be assessed as the maximum 
change in PSA from baseline as well as the change in PSA from baseline at the 9-week 
time point. For subjects who have evaluable and/or measurable metastases, the PCWG2 
criteria for response and progression in soft tissue and bone will be used. 
6.3.2 
Prophylactic medications 
Pre-medication with acetaminophen, diphenhydramine, corticosteroids, Histamine H2 
antagonists (i.e., Pepcid or equivalent) or other drugs is not anticipated; however, it will 
be employed as clinically indicated to decrease infusion reactions. Subjects with a 
history of infusional reactions to other antibody therapies or who develop reactions to 
this study agent may be pre-medicated at the discretion of the treating physician. 
6.3.3 
Intravenous administration 
Do not administer as an IV push or bolus. Sacituzumab Govitecan is administered 
intravenously as a slow infusion as described below. 
Intravenous access must be well established prior to initiating infusion. At the time of 
dosing, the IV line will be connected to an infusion container containing the prepared 
volume of Sacituzumab Govitecan. Either gravity or an infusion pump may be used. Only 
normal saline should be used as the infusion base solution, since the Sponsor has not 
examined the compatibility of Sacituzumab Govitecan with other infusion diluents. 
First infusion: Administer infusion over approximately 3 hours. Subjects should be 
observed during the infusion and for at least 30 minutes following the initial dose for 
fever, chills or other infusion-related reactions. 
Second infusion: Administer infusion over approximately 2 hours if the prior infusion 
was tolerated. Subjects should be observed during the infusion and for at least 30 
minutes after infusion. 
Subsequent infusions: Administer infusion over approximately 1-2 hours if prior 
infusions were tolerated. Subjects should be observed during the infusion. 
Following completion, the intravenous line should be flushed slowly with 20 mL normal 
saline and the end of infusion time recorded. In the event of infusion reactions or vital 
sign changes, the infusion rate may be slowed, interrupted or terminated, as considered 
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6.3.4 
Managing infusion-related reactions 
Gilead Sciences, Inc. should be notified within 24 hours of awareness; in the event of 
any serious infusion reaction. 
NCI CTCAE version 4.0 is used to grade all AEs and to provide management guidelines 
for infusion related reactions. 
For a serious infusion reaction considered severe or life threatening (NCI toxicity 
Grade 3 or higher) an infusion must be permanently terminated. 
• 
Examples of such events include: serious or clinically significant cardiopulmonary 
events, severe allergic (symptomatic bronchospasm) or anaphylactic reactions, or 
other severe reactions. 
• 
The occurrence of Grade 3 infusion-related reactions (e.g., Prolonged infusion related 
reactions-not rapidly responsive to symptomatic medication and/or brief 
interruption of infusion) also require the infusion to be permanently terminated. 
Otherwise, for moderate infusion related toxicity (Grade 2 events), the infusion should 
be temporarily stopped for at least 15 minutes or until symptoms resolve, and then 
resumed at the slowed infusion rate, if the subject is stable. 
Recommended actions for mild toxicity (Grade 1 events) include slowing the remaining 
infusion rate. 
Any infusion related reaction must have resolved to ≤ Grade 1 prior to a subject receiving 
the next scheduled infusion. 
Table 5 provides a systematic approach to infusion reactions based upon criteria 
developed by the National Cancer Institute (NCI) for classifying drug toxicity according to 
increasing levels of severity: mild (Grade 1), moderate (Grade 2), severe (Grade 3) or life- 
threatening (Grade 4). Management guidelines and examples of qualifying toxicity are 
also included. 

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Table 5. Management Guidelines for Infusion Related Reaction 
Severity 
IV Actions 
Medical Support Actions 
Examples of Qualifying Events (NCI Toxicity Criteria*) 
Mild 
Slow 
remaining 
infusion rate. 
Monitor closely 
for other 
adverse events. 
None required 
Transient hypotension; palpitations; mild 
hypertension; asymptomatic arrhythmias (none 
requiring treatment); mild allergic reaction (transient 
rash, drug fever < 38°C), or isolated fever ≤ 39°C; 
other mild reactions: flushing, rigors, chills, 
diaphoresis, pruritus, cough, pain, nausea, vomiting, 
etc. 
Moderate 
Stop 
infusion for 
15 minutes. 
Monitor. If 
stable, resume 
infusion at 
slower rate. 
For hypotension, IV fluid 
Replacement. For chills or 
rigors, pain control, moderate 
narcotic analgesic (e.g., 25 mg 
Demerol p.o. or equivalent). For 
dyspnea, initiate O2, with 
bronchodilators for subjects 
with underlying compromised 
pulmonary function. For 
general or other allergic 
reaction, antihistamines (25-50 
mg diphenhydramine or 
equivalent, p.o. or IV, 20 mg 
Pepcid, p.o. or equivalent) or 
steroids (50 mg hydrocortisone 
or equivalent, p.o. or IV) 
Infusion-related reaction responding promptly to 
symptomatic treatment and requiring prophylactic 
medication ≤ 24 hours; Hypotension requiring fluid 
replacement; advanced hypertension or symptomatic 
arrhythmias requiring non-urgent medical attention; 
moderate allergic reaction (urticaria, dyspnea, 
drug fever ≥38°C) or isolated fever 39.1 to 40°C; 
frequent or drenching diaphoresis; controlled intense 
or widespread pruritus; other moderate reactions: 
pain, GI, skin, etc. 
Severe 
Discontinue 
infusion. 
Permanently 
remove from 
treatment. 
If actions above for moderate 
severity are unsuccessful, 
initiate emergency 
resuscitative medications as 
per institutional protocol (O2, 
IM or SC epinephrine, IV 
Prolonged (not rapidly responsive to symptomatic 
medication and/or brief interruption of infusion) 
infusion- related reaction involving recurrence of 
symptoms after initial improvement; hospitalization 
indicated for other clinical sequelae; 
fluids, bronchodilators, 
antiarrhythmics, 
antihypertensives, etc) 
Congestive heart failure/LVEF < 40-20%, 
hypotension requiring sustained ≥ 24hrs therapy, 
hypertension requiring more than one drug or 
arrhythmias symptomatic and incompletely 
controlled medically or controlled with device, severe 
allergic reaction (symptomatic bronchospasm 
requiring parenteral medications, with or without 
urticaria, allergy-related edema/angioedema and 
hypotension), rigors/chills unresponsive to narcotics; 
laryngeal edema with stridor and respiratory distress, 
other severe pain, GI or skin symptoms, etc. 
Life 
Threatening 
Discontinue 
infusion. 
Permanently 
remove from 
treatment. 
Initiate emergency 
resuscitative medications as 
per institutional protocol (O2, 
airway support, 
IV epinephrine, IV fluids, 
bronchodilators, 
antiarrhythmics, 
antihypertensives, etc) 
Infusion-relation reaction which is life-threatening 
and requiring pressor or ventilator support. 
Acute myocardial infarction, tamponade, 
hypertensive crisis, life-threatening arrhythmia (e.g., 
associated with CHF, hypotension, shock), 
anaphylaxis, renal failure requiring chronic dialysis or 
renal transplant, other life-threatening or disabling 
reactions. 
*Partial list of examples. Refer to NCI CTC Version 4.0 for complete list and exact definitions. 
†Additional medical support as per Investigator judgment. 

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Additional Medications 
Subjects may be medicated during treatment as indicated in the judgment of the treating 
physician to control potential infusion or hypersensitivity responses. For anaphylactic 
reactions, 
appropriate 
medical 
measures 
(e.g., 
epinephrine, 
antihistamines, 
hydrocortisone, and IV fluids) should be taken. Such a subject should not receive 
additional study drug and should be discontinued from the study. 
Nausea, Vomiting and Diarrhea 
Gastrointestinal toxicity may be dose limiting with this study agent. Hospital or 
institutional guidelines may exist and should be consulted for recommended treatment 
of these conditions in subjects received cancer therapy. Several major oncology 
organizations have also provided comprehensive guidelines for optimal medical 
management of nausea, vomiting and diarrhea with cancer treatment. As of this writing, 
guidelines from these organizations are not stratified by toxicity grade. A partial list of 
the major medications is provided below, but the hospital/institution guidelines or the 
references below should be consulted for more detailed information as to management 
of these conditions. Subjects who exhibit an excessive cholinergic response to 
Sacituzumab Govitecan treatment (e.g., abdominal cramping, diarrhea, salivation, etc.) 
can receive appropriate premedication (e.g. Atropine) for subsequent treatments. 
 
Table 6. Recommended Medications for Nausea, Vomiting and Diarrhea 
Agent 
Dose/Frequency 
Route of 
administration 
For Prevention of Acute Emesis: 
Palonosetron 
0.075mg 
Decadron 
10-20 mg 
PO or IV 
10 mg every 12 hours 
PO or IV 
Granisetron 
1 mg or 0.01 mg/kg 
IV 
1-2 mg daily 
PO 
Ondansetron 
8 mg or 0.15 mg/kg 
IV 
16-24 mg daily 
PO 
Lorazepam 
0.5-2 mg every 4-6 hours 
PO or sublingual 
Alprazolam 
0.5-2 mg every 4-6 hours 
PO or sublingual 
For Delayed Emesis: 
Aprepitant 
125 mg on Day 1 followed by 80 mg on Days 2 & 3 
PO 
Fosaprepitant 
115 mg day 1 only 
IV 
For Diarrhea: 
Loperamide 
4 mg initially followed by 2 mg with every episode 
for a maximum of 16 mg daily. Discontinue 12 hours 
after diarrhea resolves and normal diet is resumed. 
PO 
Octreotide 
100-150 mcg three times daily 
Subcutaneously 
Fluoroquinolones (diarrhea 
persisting > 24 hrs, ANC < 500 
or fever with diarrhea) 
(e.g., ciprofloxacin 250-750 mg every 12 hours for 7 
days) 
PO 
Based on NCCN Anti-emesis Guidelines v1.2011; Benson et al (2004) Recommended guidelines for the 
treatment of cancer treatment-induced diarrhea. J Clin Oncol 22:2918-26; Kris et al (2006) American 
Society of Clinical Oncology guidelines for anti-emetics in oncology: Update 2006. J Clin Oncol 24:2932-47. 

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6.4 
Dose modification of Sacituzumab Govitecan 
The current established dose schedule for Sacituzumab Govitecan is 10 mg/kg on days 1 and 8 
repeated every 21 days given as an intravenous infusion at the rates described in Section 6.3.3. 
There should be a minimum of 14 days between the day 8 infusion and the day 1 infusion of the 
next cycle in the absence of progression of disease or unacceptable toxicity. Planned deviations 
in treatment schedule are allowable up to 7 days due to holidays, vacations or personal reasons. 
The protocol allows aggressive medical management of patients in order to avoid dose reduction 
and dose delay as much as possible. Growth factors should be initiated once the ANC starts 
decreasing and may be used prophylactically as clinically indicated. In patients who would be 
considered high risk for neutropenia (those who experienced febrile neutropenia or Grade 3-4 
neutropenia with prior treatments), use of growth factors should be initiated early on and used 
prophylactically as early as Cycle 1. Growth factors are required at cycle 1 for all patients > 65 
years old. 
 
 
6.4.1 
Dose reduction and termination guidelines 
The most likely toxicities of Sacituzumab Govitecan are expected to be gastrointestinal 
symptoms and hematologic suppression. All subjects are closely monitored over the 
course of their treatment. NCI CTCAE v4.0 is used to grade all AEs and to provide the 
following dose reduction, delay or cessation guidelines in the event of treatment-related 
toxicity. 
In this phase II study, subjects will receive 10 mg/kg Sacituzumab Govitecan once weekly 
for 2 consecutive weeks followed by 1 week rest in cycles of 21 days, with treatment 
continued in the absence of progression or unacceptable toxicity. Neutropenia, GI 
toxicity, fatigue and alopecia were the most common toxicities in phase I testing. All 
subjects will be closely monitored over the course of their treatment, with NCI CTCAE 
v4.0 used to grade all AEs and to provide dose reduction, delay or cessation guidelines in 
the event of toxicity. 
On the first treatment day (Cycle 1 Day 1), if a subject experiences ANC <1000/μl or ≥ 
Grade 2 GI toxicity (disease related or from prior treatments), treatment initiation should 
be withheld until resolved to ≤ Grade 1 or baseline level. It is recommended that growth 
factor support prophylaxis be administered to subjects who receive treatment and whose 
Cycle 1 Day 1 ANC is <1500/ul and >1000/ul. 
If recovery to ≤ Grade 1 or baseline level requires more than three-week delay, the 
subject should be withdrawn from the study. 
Treatment will be permanently discontinued for a subject in the event of any ≥ Grade 3 
infusion reactions or for any Grade 2 immediate-type allergic/hypersensitivity infusion 
reactions (e.g., generalized urticaria, wheezing, hypoxia, dyspnea), which occur after 
pre-medication with antihistamines, H2 blockers and steroids. 
Patients with grade 4 non-hematologic toxicity deemed at least possibly related must 
permanently discontinue the study drug except for the following situations: 

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a. Chloride, bicarbonate, magnesium, phosphate or glucose abnormalities that last 
<72 hours, if not clinically complicated, and resolve spontaneously or respond to 
conventional medical interventions 
b. Amylase or lipase elevations that are not associated with symptoms or clinical 
manifestations of pancreatitis. 
 
 
Treatment should be permanently discontinued if: 
a. 
ALT or AST >8x ULN 
b. 
ALT or AST>5x ULN for more than 2 weeks 
c. 
ALT or AST>3x ULN and total bilirubin >2x ULN or INR >1.5 
Patients with life threatening, grade 3 non-hematologic toxicity regardless of relationship 
to study drug should discontinue study treatment permanently. Examples include 
myocardial infarction or stroke. 
In the event of other Grade 3 treatment-related toxicity at the time of a scheduled 
treatment day, the dose will be held and subjects will be assessed at least weekly. If 
recovery to ≤ Grade 1 delays the next dose by only one week, treatment may resume 
then without dose reduction. If recovery to ≤ Grade 1 delays the next dose by 2 or 3 
weeks, treatment must be resumed at a reduced dose (Table 7). If treatment on day 8 
of a cycle is held, the dose should be skipped and treatment resumed with day 1 of the 
following cycle. If treatment on day 1 is delayed, the entire cycle should be delayed, 
maintaining the same cycle number. The use of prophylactic G-CSF in subsequent cycles 
is recommended to prevent recurrence of neutropenia that would require a dose 
reduction. If recovery to ≤ Grade 1 requires more than a three-week delay, treatment 
must be permanently discontinued. 
After cycle 1 day 1 treatment initiation should be withheld until ANC is > 1000 /uL. If day 
8 is held for ANC < 1000 /uL, that dose will be missed. Resume dosing with next cycle. If 
delay more than 4 weeks, discontinue treatment. GCSF prophylaxis prior to cycle 2 is 
recommended if clinically appropriate. 
For grade > 3 neutropenia (ANC <1000 /uL) after cycle 1 day 1 or after day 1 of subsequent 
cycles, hold day 8, initiate growth factor support and administer prophylactic growth 
factors with each subsequent cycle. Resume dosing with the next cycle only if toxicity 
resolves. In subsequent treatment cycles, treatment initiation for Day 1 of the cycle 
should be withheld until ANC > 1000 /uL and GROWTH FACTORS should be used as 
clinically indicated. Patient will be assessed weekly for grade 3 ANC (ANC <1000 /uL to 
500 /uL) and bi-weekly for grade 4 ANC (ANC <500 /uL). If delay more than 3 weeks, 
discontinue. Resume dosing at the next cycle if toxicity recovers to < grade 2 within 3 
weeks. All subsequent cycles should be administered with growth factor support. 
In the event of neutropenia grade > 3 at the time of scheduled treatment day despite 
growth factor prophylaxis, resume treatment if the toxicity recovers to < grade 2 within 
2 or 3 weeks with a 25% dose reduction for the first event (7.5mg/kg for a starting dose 

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of 10mg/kg). For subjects whose starting dose was 10mg/kg there will be a 50% dose 
reduction (5 mg/kg) for the second event that occurs while the patient is receiving 
prophylactic growth factors. Subjects will discontinue treatment for the 3rd occurrence 
while on growth factor support. NO DOSE REDUCTION IS REQUIRED IF TOXICITY 
RESOLVES WITHIN 1 WEEK. 
 
Table 7. Dose Reduction Requirements for Severe Treatment-Related Toxicity 
Event 
Occurrence 
Study Drug Dose 
Grade 4 hematologic toxicity ≥ 7 days 
OR 
Grade 3 febrile neutropenia (ANC < 1000/mm3, fever ≥ 38.5°C), 
OR 
Grade 3 thrombocytopenia with clinically relevant bleeding 
OR 
Grade 4 thrombocytopenia, regardless of duration 
OR 
Any Grade 3 nausea, vomiting or diarrhea due to treatment, or 
other Grade 3 non-hematologic toxicity persisting > 48 hours 
despite optimal medical management. 
OR 
At time of scheduled treatment, Grade 3 hematologic or Grade 3 
non- hematologic toxicity which delays dose by 2 or 3 weeks 
for recovery to ≤ Grade 2 or baseline. 
First 
7.5 mg/kg 
Second 
5 mg/kg 
Third 
Study drug will be 
discontinued 
Hematologic toxicity: ≤ Grade 1 (ANC ≥ 1500/mm3or baseline level, Platelets ≥ 75,000/mm3, or Hgb ≥ 10.0 
g/dL or baseline level); Grade 2 (ANC > 1000/mm3, Platelets >50,000/mm3, or Hgb > 8 g/dL); Grade 3 (ANC < 
1000/mm3, Platelets < 50,000/mm3, or Hgb < 8.0 g/dL); Grade 4 (ANC < 500/mm3, Platelets < 
25,000/mm3, or Hgb < 6.5 g/dL). 
Note: In the event of adverse effects unrelated to study drug administration (both hematological and non- 
hematological adverse events), decision to dose delay or dose reduce is investigator discretion, based on the 
tolerability of the toxicities. 

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The development of any of the severe toxicities noted in table 7 due to treatment requires 
permanent dose reduction for that subject by 25% of the assigned dose for first 
occurrence, 50% of the initial assigned dose for second occurrence. Subjects whose 
starting dose was 10mg/kg will discontinue treatment entirely in the event of a third 
occurrence ( Table 7). 
Do not re-escalate the Sacituzumab Govitecan dose after a dose reduction for toxicity has 
been made. 
The dose guidelines will be followed with a goal of being able to give the first cycle 
without requiring dose reduction, delay, or discontinuation or cytokine support at the 
time the second cycle is given. 
6.5 
Concomitant Therapy 
Patients will continue on the most recent ARSI on which documented progression was observed. 
For example, a patient with PSA progression on abiraterone would continue abiraterone and 
enroll on this trial. For patients that have stopped the most recent ARSI and been treated with 
another anti-cancer therapy (i.e., progression on abiraterone and then treatment with radium- 
223), the patient should resume treatment with an ARSI and show documented progression on 
that treatment before enrolling on this trial. For patients that have stopped an ARSI and then 
resumed as part of standard of care prior to this trial, a rising PSA is sufficient for eligibility. ARSI’s 
are FDA approved for the treatment of metastatic prostate cancer and will be administered per 
institutional standards in this study. 
All intercurrent medical conditions should be treated by the investigator according to current 
community standards of care. Subjects may also receive medications for symptomatic relief, such 
as analgesics, laxatives, anti-emetics, etc. 
Subjects who require palliative radiotherapy for focal symptom relief may remain on study as long 
as the treating investigator feels they are deriving benefit from Sacituzumab Govitecan and the 
radiotherapy is not to a target or non-target lesion recorded at baseline. 
Complementary/alternative therapies which may lower PSA or have an anti-hormonal effect (e.g., 
saw palmetto, selenium supplements, grape seed extract, etc.) are prohibited. 
All medications used during the study and taken within 30 days of the screening visit will be 
recorded. 
6.5.1 
Prohibited medications/treatments 
Any investigational therapies other than Sacituzumab Govitecan. 
Any other systemic therapy intended for the treatment of prostate cancer other than 
Sacituzumab Govitecan, ARSI used on study, and LHRH agonists or antagonists, which 
the subject must have started at least 3 months prior to study entry if the subject has 
not undergone orchiectomy. 

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6.6 
Drug Accountability 
Sacituzumab Govitecan will be supplied by Gilead Sciences, Inc. The investigator acknowledges 
that the drug supplies are investigational and, as such, must be used strictly in accordance with 
the protocol and only under the supervision of the investigator or sub-investigators. No study 
medication will be sent to the study site until all required regulatory documents, including IRB 
approval, are received by the sponsor or its representatives. 
Adequate records documenting receipt, use, return, loss, or other disposition of study drug vials 
must be kept. A complete drug accountability record, supplied by Gilead Sciences, Inc. (or its 
designee or NCI drug accountability forms), or computer records used by the pharmacy at the 
investigational site, can be used to provide drug accountability. 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 Monitor. Requisite data include relevant dates, quantities, batches or code numbers, 
and subject identification for subjects who received trial product. 
The investigator and investigational site staff are responsible for maintaining an accurate 
inventory and accounting of investigational drug. Receipt and use of Sacituzumab Govitecan will 
be recorded on an Investigational Drug Inventory Form provided by the sponsor, or site-required 
form if approved by the sponsor. The investigator will record the following information: 
• 
Date and quantity of Sacituzumab Govitecan received by the site 
• 
Subject number for each subject receiving Sacituzumab Govitecan 
• 
Date and quantity of Sacituzumab Govitecan dispensed to each subject 
• 
Date and quantity of Sacituzumab Govitecan returned to inventory from each subject 
• 
The name of the person dispensing investigational drug 
• 
Each shipment of Sacituzumab Govitecan will be accompanied by an invoice describing the 
amount of drug shipped to the site. The information on the invoice must be verified against 
the actual amount of Gilead Sciences, Inc. drug received by the site; the investigator or the 
investigator’s designee will then sign the invoice and place it in the investigator’s file. 
At each monitoring visit, the monitor will reconcile the information on the Investigational Drug 
Inventory Form with the actual amount of Sacituzumab Govitecan remaining at each site. At the 
conclusion of the study, all unused drug supplies must be returned to the sponsor or its designee, 
or destroyed according to institutional operating standards. Drug accountability will be performed 
on site by the clinical monitor before destruction, unless approval is given to destroy prior to 
monitoring. A record of the destruction will be placed in the investigator’s file. 
Unused investigational product must not be discarded or used for any purpose other than the 
present study. Investigational product which has been dispensed to a subject and returned 
unused must not be re-dispensed to a different subject, but may be dispensed to the same 
subject. 
At the end of the study, following authorization by study management, study medication may be 
destroyed at the site as dictated by the appropriate standard operating procedures at the 
participating institutions. Destruction must be documented. Alternatively, after notification, all 
unused products will be collected by the Study Monitor and returned to Gilead Sciences, Inc.. 

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7. 
SAFETY EVALUATION 
7.1 
Definitions 
7.1.1 
Adverse event (AE) 
All subjects must be carefully monitored for AEs, including clinical laboratory tests. AEs 
should be assessed in terms of their seriousness, intensity, and relationship to the study 
drug. For consistency, events are to be graded using the CTCAE version 4.0. 
An AE is any untoward medical occurrence in a subject or clinical investigation subject 
administered a pharmaceutical product, and which does not necessarily have to have a 
causal relationship with this treatment. An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding, for example), symptom, or 
disease temporally associated with the use of a medicinal product, whether or not 
considered related to the medicinal product. 
AEs include the following: 
1. An exacerbation, or an unexpected increase in frequency or intensity of a pre- 
existing condition (other than condition under investigation), including intermittent 
or episodic conditions. 
2. Significant or unexpected worsening or exacerbation of the condition/indication 
under investigation. 
3. A suspected drug interaction. 
4. An intercurrent illness. 
5. Any clinical significant laboratory abnormality. 
An AE does not include: 
1. Anticipated day-to-day fluctuations of any pre-existing conditions, including the 
disease under study. 
2. Signs and symptoms of the disease under study that do not represent a 
significant worsening or exacerbation. 
3. Expected progression of the disease under investigation. 
 
7.1.2 
Adverse drug reaction 
All noxious and unintended responses to a medicinal product related to any dose should 
be considered adverse drug reactions (ADRs). The phrase “responses to a medicinal 
product” means that a causal relationship between a medicinal product and an adverse 
event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. 
Causality assessment is required for all clinical investigation cases. All cases judged by 
either the reporting health care professional or the sponsor as having a reasonable 
suspected causal relationship to the medicinal product qualify as ADRs. 
7.1.3 
Unexpected adverse drug reaction 
An unexpected ADR is an AE where the nature or severity of which is not consistent with 
the applicable product information (e.g., Investigational Brochure, study protocol or ICF). 
The following documents or circumstances will be used to determine whether an AE/ADR 
is expected: 

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• For a medicinal product not yet approved for marketing in a country, a company’s 
Investigational Brochure, study protocol or ICF will serve as the source document in 
that country. 
• Reports which add significant information on specificity or severity of a known, already 
documented serious ADR constitute unexpected events. For example, an event more 
specific or more severe than described in the Investigational Brochure would be 
considered “unexpected.” Specific examples would be (a) acute renal failure as a 
labeled ADR with a subsequent new report of interstitial nephritis and (b) hepatitis 
with a subsequent report of fulminant hepatitis. 
7.1.4 
Serious Adverse Event (SAE) 
A serious adverse event (SAE) or reaction is any untoward medical occurrence that at 
any dose: 
• Is life-threatening (an event in which the subject was at risk of death at the time of the 
event; it does not refer to an event which hypothetically might have caused death if it 
were more severe). 
• Results in death. 
• Requires in-patient hospitalization or prolongation of existing hospitalization. 
• Results in persistent or significant disability/incapacity. 
• Is a congenital anomaly or birth defect. 
• Disabling/incapacitating 
• Other important medical events that may not be immediately life-threatening or result 
in death or hospitalization but may jeopardize the subject or may require intervention 
to prevent one of the other outcomes listed above. Examples of such events are 
intensive treatment in an emergency room for allergic bronchospasm; blood 
dyscrasias or convulsions that do not result in hospitalization; or development of drug 
dependency or drug abuse. The term “severe” is often used to describe the intensity 
(severity) of an event; the event itself may be of relatively minor medical significance 
(such as a severe headache). This is not the same as “serious”, which is based on 
subject/event outcome or action criteria usually associated with events that pose a 
threat to a subject’s life or functioning. 
• An SAE does not include: Progression of the underlying disease or hospitalization for 
a routine clinical procedure as stipulated by the protocol and hospitalization for 
elective or pre-planned procedure not associated with a precipitating event or non- 
medical reasons (i.e., social admissions, hospitalizations for social, convenience or 
respite care. 
7.1.5 
Exposure During Pregnancy 
Pregnancy occurring in female partners of male subjects while the male partner is 
receiving study drug within 120 days after the final dose should be reported within 24 
hours of becoming aware of the event. 
 
The investigator should counsel the subject, and in the case of a male subject, the 
subject’s partner, regarding the risks of continuing with the pregnancy and the possible 
effects on the fetus. If the female partner of a male subject becomes pregnant, the 
investigator should obtain informed consent of the pregnant partner, if allowable per 

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local policy, prior to monitoring the pregnancy. Monitoring of the pregnancy in the female 
partner of the male subject should continue to the conclusion of the pregnancy. The 
outcome of all pregnancies (including normal births) must be reported. Follow-up 
information on the status of the infant should be collected and reported until 90 days 
post-partum, including anomalies diagnosed at birth or within 90 days post-partum, and 
condition at birth, neonatal illnesses, hospitalizations, and drug therapies. Complications 
of pregnancy, such as abortion (spontaneous or induced), premature birth, or congenital 
anomaly are considered SAEs. 
 
The Sponsor must be notified of any subject’s partner becoming pregnant during the 
study or of any spontaneous abortion or of any therapeutic abortion and any pregnancy 
must be followed until completion or termination of pregnancy, if allowable per local 
policy. The notification should be performed on the pregnancy form and handled in the 
same manner as for SAEs. In the case of a live birth, the “normality” of the newborn can 
be assessed at the time of birth. The “normality” of an aborted fetus can be assessed by 
gross visual inspection unless pre-abortion laboratory findings are suggestive of a 
congenital anomaly. 
 
All pregnancies of any subject’s partner, from the time of treatment/ allocation through 
120 days following cessation of study treatment, or 30 days following cessation of study 
treatment if the subject initiates new anticancer therapy must be reported by the 
investigator. 
7.2 
Documenting Adverse Events 
The investigator should elicit information regarding the occurrence of AEs through open-ended 
questioning of the subject, physical examination and review of laboratory results. 
All AEs, whether serious or not, will be described in the source documents and the AE page of the 
electronic case report form (eCRF). AEs will be reported from the time of signing of informed 
consent, however AEs captured prior to the initial administration of Sacituzumab Govitecan will 
not be considered related to study drug. All new events, as well as those that worsen in intensity 
or frequency relative to baseline, which occur after administration of study drug through the 
period of protocol-specified follow-up, must be captured. AEs occurring for 30 days after the last 
dose of study drug must be reported. SAEs, felt by the investigator to be related to study drug, 
however, must be reported any time the investigator becomes aware of such an event, even if 
this occurrence is more than 30 days after the last dose of study drug. 
Abnormal laboratory values per se need not be reported as AEs. Abnormal laboratory values that 
result in clinical sequelae, that require intervention, that are deemed clinically significant by the 
investigator or investigator’s designee, that are SAEs, that result in a change in protocol 
treatment, or that result in study discontinuation should be reported as AEs. 
Information to be reported in the description of each AE includes: 
• A medical diagnosis of the event (if a medical diagnosis cannot be determined, a description 
of each sign or symptom characterizing the event should be recorded). 
• The date of onset of the event or whether it is ongoing. 

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• Whether the event is serious or not. 
• Action taken in response to the event. 
• Action taken with study drug. 
• Outcome. 
 
7.3 
Reporting of Adverse Events and Serious Adverse Events 
The Investigator is to report all AEs directly observed or spontaneously reported by subjects 
using concise medical terminology. Each subject will be questioned about AEs at each clinic or 
evaluation visit, asking, for example, “Since your last clinic visit have you had any health 
problems?” 
The AE reporting period begins with informed consent and ends with the last scheduled study 
evaluation or until all drug related toxicities and ongoing SAEs have resolved, whichever is later. 
All AEs must be reported in the eCRF, whether or not considered related to study medication 
using the appropriate forms/procedure. 
7.3.1 
Reporting serious adverse events 
All SAEs, events determined to be medically significant by the treating Investigator, and 
unknown reactions or unexpected events should be reported to the PCCTC within 24 
hours of knowledge of the event using the contact information below. The initial report 
should include the following information at a minimum: 
• protocol # and title 
• subject identification number, sex, age at event 
• date the event occurred 
• description of the SAE 
• causal relationship to the study treatment(s) 
The MedWatch Form will be used for reporting each SAE and should be submitted to the 
PCCTC Project Coordinator with the minimum information within 24 hours. The PCCTC 
will facilitate all SAE report form submissions to the Sponsor-Investigator (UW PI). 
Grade, relationship, action taken, concomitant medications, outcome, etc. should be 
reported to the PCCTC as soon as possible. 
Follow-up of adverse events should continue until the event and any sequela resolve or 
stabilize at a level acceptable to the investigator. 
SAE contact information for the PCCTC is listed below. 
PCCTC: 
Prostate Cancer Clinical Trials Consortium 
Email: pcctc@mskcc.org 
For SAEs, the PCCTC is to be notified by the Investigator, using the designated form, 
within 24 hours of the event. The initial report is to be followed by submission of 
more detailed SAE information within 5 calendar days of the initial report. 

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The PCCTC will facilitate the notification of SAEs to Gilead Sciences, Inc. All SAEs and 
pregnancies should be reported to: Email: sacituzumab_govitecan_SO@iqvia.com 
 
 
7.3.2 
Other reporting requirements 
University of Wisconsin Carbone Cancer Center (UWCCC) site: SAEs that occur at UWCCC 
require reporting to the PCCTC within 24 hours, so submission to the UWCCC DSMC via 
an email to saenotify@uwcarbone.wisc.edu must be done within that same 24 hour 
period. The OnCore SAE Details Report must be submitted along with other report 
materials as applicable (UWCCC SAE Routing Form, Sponsor-Investigator Determination 
Form for FDA Reporting of Safety Events, FDA Medwatch Form #3500A, supporting 
documentation). Follow-up information for the SAE must be submitted to 
saenotify@uwcarbone.wisc.edu within 5 calendar days of the initial report. 
 
Non-UWCCC participating sites: For SAEs occurring at non-UWCCC sites, the site will 
submit FDA Medwatch form 3500A and other protocol-specific SAE reporting to the 
PCCTC (pcctc@mskcc.org) within 24 hours of the site being made aware of the event. The 
PCCTC will then forward the SAE information to the UWCCC study team 
(uwcccgu@medicine.wisc.edu). . The UWCCC study team will complete the UWCCC 
Sponsor-Investigator Determination Form for FDA Reporting of Safety Events. 
 
SAE information will be entered and tracked in the UWCCC secure, password protected 
computer network. 
 
Reporting to the FDA 
Serious Adverse Events occurring on studies on which a UW PI is acting as sponsor- 
investigator must be reported to the FDA by UWCCC within the appropriate time frame. 
Mandatory and voluntary reporting guidelines and instructions are outlined on the FDA 
website: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm 
 
Sponsor-Investigator Responsibilities for SAE Review 
The Sponsor-Investigator (i.e., the individual who holds the IND) assumes responsibilities 
of the study sponsor in accordance with FDA 21 CFR 312.32. In this capacity, the Sponsor- 
Investigator reviews all reports of serious adverse events occurring on the study at the 
UWCCC and other participating sites and makes a determination of 1) suspectedness (i.e., 
whether there is a reasonable possibility that the drug caused the SAE); and 2) 
unexpectedness (the event is not listed in the Investigator’s Brochure or is not listed at 
the specificity or severity that has been observed) in the context of this study. 
 
Expedited Reporting 
SAEs with suspected causality to study drug and deemed unexpected are reported as IND 
Safety Reports by the Sponsor-Investigator to FDA, all PIs participating on the study at 
other sites, and the external global sponsor (if applicable) within 15 calendar days. All 
fatal or life-threatening SAEs that are unexpected and have suspected causality to the 
study drug will be reported by the sponsor-investigator to FDA, all PIs participating on the 
study at other sites, and the external global sponsor (if applicable) within 7 calendar days. 

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7.4 
Grading and Relatedness of Adverse Events 
7.4.1 
Grading of severity of an AE 
The severity of each AE will be graded using the NCI CTCAE Version 4.0, which may be 
found at http://ctep.cancer.gov/reporting/ctc.html. In most cases AE terms will be listed 
in the CTCAE, with grading criteria specific to that term. If the AE is not specifically defined 
in the CTCAE, it is to be reported using the “Other, specify” term under the appropriate 
system organ class and graded according to the general CTCAE severity guidelines. 
For each event, the highest severity grade should be reported. If a CTCAE criterion does 
not exist, the Investigator should use the grade or adjectives as described in Table 8. 
 
 
Table 8. Grading of Adverse Event Severity 
Grade 
Adjective 
Description 
Grade 1 
Mild 
Does not interfere with subject's usual function 
Grade 2 
Moderate 
Interferes to some extent with subject's usual function 
Grade 3 
Severe 
Interferes significantly with subject's usual function 
Grade 4 
Life-Threatening Results in a threat to life or in an incapacitating disability 
A severe reaction (e.g., a severe headache) would not be classified as serious unless it 
met one of the criteria for SAE(s) listed above. 
 
 
7.4.2 
Relatedness to study drug 
The investigator must attempt to determine if an AE is in some way related to the use of 
the study drug. This relationship should be described as follows: 
Unrelated: The event has no temporal relationship to study drug administration (too early 
or late or study drug not taken), or there is a reasonable causal relationship between the 
AE and another drug, concurrent disease or circumstance. 
Unlikely: The event with a temporal relationship to drug administration which makes a 
causal relationship improbable, and in which other drugs, chemicals or underlying disease 
provide plausible explanations. 
Possible: The event follows a reasonable temporal sequence from administration of the 
study drug and the event follows a known response pattern to the study drug BUT the 
event could have been produced by an intercurrent medical condition which, based on 
the pathophysiology of the condition, and the pharmacology of the study drug, would be 
unlikely related to the use of the study drug or the event could be the effect of a 
concomitant medication. 
Definite: The event follows a reasonable temporal sequence from administration of the 
study drug, the event follows a known response pattern to the study drug and based on 
the known pharmacology of the study drug, the event is clearly related to the effect of 
the study drug. 

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Reporting requirements for AEs are summarized in Table 9: 
 
Table 9. Reporting Requirements for Adverse Events 
Reporting Time 
Type of Report 
SERIOUS 
Within 24 hours 
Initial report on designated SAE form 
Within 5 calendar days of initial 
report 
Follow-up/Final report on designated form 
NON-SERIOUS 
Per CRF submission procedure 
Appropriate CRF pages 
 
7.4.3 
Recording information on AEs 
All AEs, whether observed by the Investigator, elicited from, or volunteered by the 
subject, will be recorded including: duration, severity, relationship to the study 
medication, treatment, action taken with respect to the study medication and outcome. 
When possible, all events should be reported in diagnostic terms or the most acceptable 
medical terms in order to interpret safety information accurately. 
The investigator must review all laboratory test data and record any AEs. The same 
format will be used as for other AEs, regardless whether related to study therapy or not, 
including event severity grading, attribution, and resolution. A summary listing of all AEs 
occurring during the past year on this study will be provided in progress reports reported 
to regulatory authorities. 
7.5 
Follow-up of Unresolved Adverse Events 
All AEs should be followed until they are resolved or the Investigator assesses them as chronic 
or stable or the subject’s participation in the trial ends (i.e., until a final report is completed for 
that subject). Instructions for reporting changes in an ongoing AE during a subject's participation 
in the trial are provided in the instructions that accompany the AE CRFs. 
In addition, all SAEs and those non-SAEs assessed by the Investigator as possibly related to the 
investigational medication/product should continue to be followed even after the subject's 
participation in the trial is over. Such events should be followed until they resolve or until the 
Investigator assesses them as “chronic” or “stable.” Resolution of such events is to be 
documented on the appropriate CRF. 
 
 
8. 
STATISTICAL CONSIDERATIONS 
8.1 
Data Management 
Data from the study will be entered into eCRFs. Data may only be entered by authorized 
personnel. The data will be periodically monitored by the clinical monitor; in addition, 
programmatic edit checks will review the data for correctness, logic and consistency. Based on 
the monitoring findings and the edit checks, queries may be issued to the clinical site for data 
clarification. The results of all original entries, as well as any corrections, will be maintained by 
the data management system. The principal investigator will review and approve all data entries 
with electronic signature on the eCRF. 

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8.2 
Study Design 
A multi-arm, multi-institutional phase II study design will be used to assess the efficacy of 
Sacituzumab Govitecan in subjects with metastatic CRPC progressing on an ARSI. Patients will 
continue treatment on the ARSI and enroll on this trial. Prior exposure and sensitivity to second 
generation AR-directed therapy will be recorded and subjects will be considered to have 
responded (i.e., were sensitive) to the prior agent if there was a ≥50% PSA decline from baseline. 
Treatments can continue until radiographic disease progression, unacceptable toxicity, initiation 
of alternative therapy or withdrawal of consent. 
8.3 
Determination of Sample Size 
The primary endpoints for the study are (1) PSA response rate, which is defined as the proportion 
of subjects achieving a ≥50% decline in PSA at or within 9 weeks of starting Sacituzumab 
Govitecan. Prior published data from retrospective studies report PSA response rates (≥50% 
decline) in 20-30% of subjects on 2nd line AR directed therapy after progression on a 1st line agent 
in the pre-docetaxel setting (3-8), (2) and the 6-month rPFS rate. The response rate appears higher 
with cytotoxic chemotherapy. Although data are limited in the pre-docetaxel setting, 
retrospective studies in the post-docetaxel setting suggest patients with prior response to 
abiraterone are more likely to respond to second line enzalutamide (9-11). The familywise type I 
error for the two primary endpoints of the study is one-sided 0.05 and a Bonforreni adjustment 
for evaluating two primary endpoints will be applied that each endpoint will be tested at the one- 
sided 0.025 (0.05/2) significance level. A PSA response rate of 20% or less will be considered as 
unacceptably low. A PSA response rate of 40% or more, on the other hand, will be considered 
sufficient evidence to consider further clinical trial investigation. Hence, the null hypothesis that 
the PSA response rate is 20% will be tested against the alternative hypothesis that the PSA 
response rate is 40%. A sample size of 45 evaluable subjects for PSA response (defined as subjects 
who received at least 1 dose of Sacituzumab Govitecan and have at least 1 post-dose assessment 
of PSA) is required to detect an increase in the PSA response rate from 20% to 40% with 87% 
power at the one-sided exact test with a significance level of 0.025 . Analogously, a 6-month rPFS 
rate of 20% or less will be considered as unacceptably low and 40% or more considered sufficient 
evidence. Again a sample size of 45 evaluable subjects (for assessing 6-month PFS rate) is required 
to detect an increase in the 6-month rPFS rate from 20% to 40% with 87% power at the one-sided 
0.025 significance level. The following table shows the probabilities for rejecting the null 
hypothesis with a sample size of 45 evaluable subjects, assuming that the true PSA response/6- 
month rPFS rates range between 35-50%. 
 
Table 10. Attainable power levels with a sample size of 45 evaluable subjects 
True PSA response/6-months PFS rate 
Probability of rejecting null hypothesis 
35% 
68% 
40% 
87% 
45% 
96% 
50% 
>99% 
Hence, a sample size of 45 evaluable subjects will provide between 68-99% power to detect a true 
PSA response rate or 6-month rPFS rate between 35-50% at the one-sided 0.025 significance level. 

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A sample size of 45 subjects will also be adequate for estimating toxicity rates with sufficient 
accuracy. Specifically, toxicity rates will be estimated with a standard error of less than 8% and 
the corresponding 95% confidence intervals will be no wider than 30%. 
In order to account for unevaluable (for assessing PSA response or 6-month rPFS rate) subjects, 
55 subjects in total will be enrolled. 
8.4 
Analysis Plan 
8.4.1 
Baseline and Demographic Analysis 
The disposition of all subjects (number of subjects enrolled, treated, completed, 
discontinued and replaced) will be presented. Demographic and baseline subject 
characteristics will be summarized (e.g., age, race, ethnicity, ECOG Performance Score, 
prior medical history, prior therapy and response to prior therapy). 
8.4.2 
Safety Analysis 
The Safety Analysis Set will consist of all subjects who received at least 1 dose of 
Sacituzumab Govitecan. 
Safety parameters will include results of AE reporting, physical exam findings, vital signs, 
safety laboratory determinations and ECGs. AEs will be listed according to the MedDRA 
coding dictionary by system organ class, preferred term and high level terms. All AEs will 
be classified by type, severity, and causality. In addition to all AEs, SAEs, drug-related AEs, 
Grade 3 or higher AEs, drug-related Grade 3 or higher AEs, and AEs leading to 
discontinuation or death will be described. A customized drug dictionary will be used to 
classify concomitant medications by therapeutic class and preferred term. 
Changes from baseline assessments (e.g., laboratory parameters, vital signs and ECG 
parameters) will be presented using descriptive statistics. The distribution of the 
maximum observed grade of each AE will be tabulated. Toxicities will be summarized by 
type and severity in tabular format. Toxicity rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, 
Grade ≥ 3, etc.) will be calculated and reported along the corresponding 95% confidence 
intervals. The 95% confidence intervals will be constructed using the Wilson score 
method. 
The safety analyses will be stratified by subjects who continued single agent ARSI in 
combination with Sacituzumab Govitecan and patients who discontinued single agent 
ARSI before starting Sacituzumab Govitecan. 
 
 
 
 
8.4.3 
Efficacy Analysis 
The Efficacy Analysis Set will consist of all subjects who receive at least 1 dose of 
Sacituzumab Govitecan and have at least 1 post-dose assessment of PSA; and/or 1 post- 
dose radiographic assessment for subjects with evaluable and/or measurable metastases 
at screening, 1 post-dose assessment of metastatic disease will be required. Subjects who 

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discontinue study participation early so they do not meet criteria for inclusion in the 
efficacy analysis set can be replaced. 
Changes in PSA will be compared to baseline and maximal change from baseline and 
change at Week 9 (e.g., end of Cycle 3) will also be determined, as will duration of 
response. Maximum change in soft tissue lesions as seen on CT or MRI of the chest, 
abdomen and pelvis, as well as changes on bone scintigraphy according to the PCWG2 
criteria will also be compared to baseline, and summarized. 
A subgroup efficacy analysis will be conducted in the group of patients who continued 
single agent ARSI in combination with Sacituzumab Govitecan. 
 
 
Definition and analysis of primary efficacy endpoint: 
PSA response rate: Subjects who achieve ≥50% PSA decline at or before 9 weeks of 
therapy with Sacituzumab Govitecan are considered to have responded. PSA responses 
will be analyzed by descriptive statistics and summarized in tabular format (frequency 
tables). The overall PSA response rate will be reported along with the corresponding 95% 
confidence interval which will be constructed using the Wilson score method. 
6-month rPFS rate: Proportion of subjects remaining alive and progression free (using 
PCWG2 criteria) 6 months from time of starting treatment as estimated by the Kaplan- 
Meier method. The point estimate of the 6-month rPFS rate will be reported along with 
the corresponding two-sided 95% confidence interval. 
 
Definition and analysis of secondary efficacy endpoints: 
i. 
Median rPFS. The probability distribution of PFS will be estimated using the Kaplan- 
Meier method. The median will be estimated from this distribution. Subjects who 
have not died or progressed (using PCWG2 criteria) will be censored at the date of 
last assessment. 
ii. Median OS. OS is the duration from start of treatment until death from any cause. 
The probability distribution of OS will be estimated using the Kaplan-Meier method. 
The median will be estimated from this distribution. Subjects who have not died will 
be censored at the date of last contact. 
Response. The number and frequencies of subjects with progressive disease, stable 
disease, partial response and complete response will be summarized in tabular 
format. The overall response rate will be reported along with the corresponding 95% 
confidence interval which will be constructed using the Wilson score method. 
8.5 
Correlative Biomarker Analysis 
An exploratory endpoint of the study is to evaluate the predictive accuracy of potential 
biomarkers for the PSA response and rPFS endpoints. Other exploratory objectives include 
assessment of mechanisms of resistance to Sacituzumab Govitecan via biomarker analysis of post- 

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progression tumor tissue. These analyses will be mostly descriptive for future references. All 
exploratory endpoints will be summarized using standard descriptive statistics, stratified by 
assessment time point. Longitudinal changes will be evaluated using a linear or generalized linear 
mixed effects model. 
A Cox proportional hazards regression model (for the rPFS endpoint) and a logistic regression 
model (for the PSA response endpoint) will be used to assess the prognostic significance of 
baseline factors both alone and in combination with other biomarkers (e.g., clinical parameters, 
LDH, Hb). For each regression model, the c-index will be used to quantify the predictive accuracy 
of these biomarkers. 
9. 
ADMINISTRATIVE PROCEDURES 
9.1 
Pre-Study Documentation 
Prior to initiating the study, the Investigator will provide to the sponsor the following documents: 
• A signed FDA Form 1572 
• A current curriculum vitae for the principal investigator and each sub-investigator listed on the 
FDA Form 1572 
• A copy of the current medical license for the investigator 
• A letter from the IRB stipulating approval of the protocol, the informed consent document and 
any other material provided to potential study participants with information about the study 
(e.g., advertisements) 
• A copy of the IRB-approved informed consent document 
• The current IRB membership list for the reviewing IRB, or the multiple project assurance 
number from the Federal Wide Assurance program (www.ohrp.osophs.dhhs.gov). 
• A fully signed Investigator Protocol Agreement 
• A completed financial disclosure form for the investigator and all sub-investigators 
• Current laboratory certification for the reference laboratory and curriculum vitae of the 
laboratory director 
• A list of current laboratory normal values for the reference laboratory 
9.2 
Source Documents 
The investigator will maintain records separate from the eCRFs in the forms of clinic charts, 
medical records, original laboratory, radiology and pathology reports, pharmacy records, etc. The 
investigator will document in the clinic chart or medical record the date on which the subject 
signed informed consent prior to the subject’s participation in the study. Source documents must 
completely reflect the nature and extent of the subject’s medical care, and must be available for 
source document verification against entries in the eCRFs when the sponsor’s monitor visits the 
investigational site. All information obtained from source documents will be kept in strict 
confidentiality. 

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9.3 
Study Ethics 
9.3.1 
Ethics statement 
The study will be performed according to the principles of the Declaration of Helsinki 
(Appendix D), the International Conference on Harmonization Guidance on Good Clinical 
Practice, as adopted by applicable laws and regulations, and the requirements of the FDA 
regarding the conduct of human clinical studies. This study is planned to be conducted 
both in the North America. 
The Institutional Review Board (IRB) and/or the Institutional Ethics Committee (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, in 
accordance with IRB/IEC policies. 
All correspondence with the IRB/IEC should be retained in the Investigator File. 
Copies of IRB/IEC approvals should be forwarded to Gilead Sciences, Inc. or the designee. 
9.3.2 
Informed consent 
It is the responsibility of the Investigator to give each subject (or the subject’s legal 
representative) full and adequate verbal and written information regarding the objective 
and procedures of the trial including the possible risks and benefits involved. Written 
subject information, approved by the IRB/IEC must be given to each subject before any 
trial-related procedure is undertaken. During the consent process, the subject must be 
informed about their right to withdraw from the trial 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 trial-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 trial 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 Gilead 
Sciences, Inc. 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 trial if the subject agrees to the 
Investigator informing the primary care physician. 

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No study related procedures will be performed until a subject or a subject’s legal 
representative has given written informed consent. The sponsor will provide to the 
investigator a sample informed consent document that includes all the requirements for 
informed consent according to U.S. FDA guidelines (21 CFR 50). However, it is up to the 
investigator to provide a final informed consent that may include additional elements 
required by the investigator’s institution. The informed consent document must clearly 
describe the potential risks and benefits of the study, and each prospective participant 
must be given adequate time to discuss the study with the investigator or site staff and 
to decide whether or not to participate. Each subject who agrees to participate in the 
study and who signs the informed consent will be given a copy of the signed, dated and 
witnessed document. The provision of informed consent will be documented in the 
medical record. 
9.3.3 
Investigational Review Board approval 
The study will not be initiated until there is approval of the protocol, informed consent 
document and any other material used to inform the subject about the nature of the 
study by the IRB. The IRB should be duly constituted according to regulatory 
requirements. Approval must be in the form of a letter signed by the Chairperson of the 
IRB or the Chairperson’s designee, must be on IRB or IEC stationary and must include the 
protocol by name and/or by designated number. If an investigator is a member of the IRB, 
the approval letter must stipulate that the investigator did not participate in the final 
vote, although the investigator may participate in the discussion of the study. The 
investigator will also inform the IRB of any SAEs that the sponsor reports to regulatory 
authorities, will report on the progress of the trial at least yearly (or more frequently if 
required by local regulation or guidance) and will provide to the IRB a final summary of 
the results of the study at the conclusion of the study. 
9.4 
Data and Safety Monitoring 
9.4.1 Data and safety monitoring plan 
UWCCC site: This protocol undergoes review of subject safety at regularly scheduled 
Disease Oriented Team (DOT) meetings where the following are discussed as applicable: 
number of subjects enrolled, subject treatments given, dose holds/modifications, 
significant toxicities, and response to treatment. These discussions will be documented in 
the DOT meeting minutes. 
UWCCC Data and Safety Monitoring Committee (DSMC) Study Progress Review 
The following information enables the UWCCC DSMC to assess whether significant 
benefits or risks are occurring that would warrant study suspension or closure. In the 
event that there is a significant risk warranting study suspension or closure, the UWCCC 
DSMC will notify the sponsor-investigator of the findings and ensure the appropriate 
action is taken for the study. The UWCCC ensures that the Sponsor-Investigator reports 
any temporary or permanent suspension of the clinical trial to the appropriate parties. 
 
UWCCC site: Based on the risk level of the study, Protocol Summary Reports (PSRs) must 
be submitted to the UWCCC DSMC twice yearly. 

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Non-UWCCC participating sites: The PCCTC will prepare summary information as noted 
below in section 9.4.2 UWCCC Data and Safety Monitoring Committee (DSMC) Oversight, 
which will also be submitted to the UWCCC DSMC by the UWCCC study team at the time 
of the PSRs. 
 
PCCTC oversight activities include: 
• 
Review all adverse events requiring expedited reporting as defined in the 
protocol 
• 
Notify Sponsor-Investigator of adverse events requiring expedited reporting at 
Safety_FC@gilead.com within 24 hours of the Investigator’s awareness. 
• 
Provide trial accrual progress, safety information, and data summary reports to 
the sponsor-investigator 
 
 
 
9.4.2 UWCCC Data and Safety Monitoring Committee (DSMC) oversight 
The UWCCC DSMC will review this clinical trial for subject safety, protocol compliance, 
and data integrity. This is achieved by their twice yearly review of the following: 
• 
Study accrual patterns 
• 
Cumulative summary report of all Serious Adverse Events (SAEs) 
• 
Cumulative summary report of all responses to treatment 
• 
Cumulative summary report of all non-compliance, unanticipated problems, and 
other IRB reportable events 
The UWCCC DSMC will review UWCCC PSRs and participating site summary information 
twice yearly. Documentation of these reviews and the UWCCC DSMC recommendation 
(e.g., protocol continuation, protocol continuation with modifications, protocol 
suspension, or discontinue protocol or treatment arm) will be provided to the Sponsor- 
Investigator and the PCCTC (pcctc@mskcc.org). Issues of immediate concern will be 
brought to the attention of the Sponsor-Investigator and other regulatory bodies as 
appropriate. The Sponsor-Investigator will work with the PCCTC to address these 
concerns. 
9.4.3 
Review and oversight requirements 
UWCCC DSMC Review of Auditing and/or Monitoring Reports 
Reports created through the auditing and/or monitoring activities of the PCCTC are 
submitted in real-time by the PCCTC to the UWCCC DSMC via an email to 
DSMC@uwcarbone.wisc.edu. Following UWCCC DSMC review of these reports, the 
committee may issue a request for corrective and/or preventive action(s), protocol 
suspension, or for-cause audit(s). 
 
UWCCC DSMC Review of Non-compliance, Unanticipated Problems, and Other IRB 
Reportable Events 
Reports of non-compliance, unanticipated problems, and other IRB reportable events are 
submitted to the IRB of record for the site at which the event occurred and to the PCCTC 

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simultaneously. The PCCTC will then forward the event information to the Sponsor- 
Investigator within 24 hours of receipt. The Sponsor-Investigator, or designee, will submit 
the event information to the UWCCC DSMC within 24 hours of receipt from the PCCTC. 
 
Real-time UWCCC DSMC Review of SAEs 
The UWCCC DSMC Chair, or designee, will review SAE information and determine if 
immediate action is required. 
 
UWCCC site: The Principal Investigator (PI), or designee, notifies the following 
individuals/entities of SAEs as applicable: 
• 
Other investigators involved with the study at the UWCCC 
• 
IRB of record for the study conducted at the UWCCC 
• 
UWCCC DSMC (see section 7.3.2 – Other reporting requirements) 
• 
PCCTC 
 
Non-UWCCC participating sites: The site PI, or designee, notifies the following 
individuals/entities of SAEs as applicable: 
• 
Other investigators involved with the study at the site 
• 
IRB of record for the study conducted at the site 
• 
PCCTC 
9.5 
Confidentiality 
It is the responsibility of the investigator to ensure that the confidentiality of all subjects 
participating in the study and all of their medical information is maintained. eCRFs and other 
documents submitted to the sponsor must never contain the name of a study subject. All subjects 
in the study will be identified by a unique identifier which will be used on all CRFs and any other 
material submitted to the sponsor. All study documents and any identifying information must be 
kept in a secure location with access limited to the study staff directly participating in the study. 
Personal medical information may be reviewed by representatives of the sponsor, of the IRB or 
the FDA in the course of monitoring the progress of the study. Every reasonable effort will be 
made to maintain such information as confidential. 
The results of the study may be presented in reports, at scientific meetings or published in 
scientific journals; however, subject names will never be used in such reports, presentations or 
publications. 
9.6 
Protocol Amendments 
The protocol will only be amended with the consent of the sponsor and the IRB. Changes to the 
protocol must be in the form of a written amendment; changes other than those of a simple 
administrative nature (e.g., a new telephone number for a medical monitor) must be submitted 
by the investigator to the IRB and such amendments will only be implemented after approval of 
the requisite IRB. All amendments will also be submitted by the sponsor to the FDA. 
Protocol changes to eliminate an immediate hazard to a study subject may be implemented by 
the investigator immediately. The investigator must then immediately inform the local IRB or IEC 
and the sponsor will immediately notify local regulatory authorities. 

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All protocol amendments will be submitted to local regulatory authorities by the sponsor as 
required by local regulation. 
9.7 
Protocol Compliance 
The Investigator will conduct the study in compliance with the protocol and given approval by 
the IRB/IEC and the appropriate regulatory authorities. 
Modifications to the protocol should not be made without agreement of both the Sponsor- 
Investigator and Gilead Sciences, Inc. 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 subjects. 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. University of Wisconsin or its designee, the PCCTC, will submit all protocol modifications 
to the regulatory authorities in accordance with the governing regulations. 
When immediate deviation from the protocol is required to eliminate an immediate hazard(s) to 
subjects, the Investigator will contact the PCCTC, if circumstances permit, to discuss the planned 
course of action. Any departures from the protocol must be fully documented in the subject’s 
CRF and source documentation. 
9.8 
Site Monitoring and On-Site Audits 
A clinical monitor will make regularly scheduled trips to the investigational site to review the 
progress of the study. The actual frequency of monitoring trips will depend on the enrollment rate 
and performance at each site. As required by federal regulations, the investigator will allow access 
to all pertinent medical records in order to allow for the verification of data gathered in the eCRFs 
and for the review of the data collection process. At each visit, the monitor will review various 
aspects of the study including, but not limited to: screening and enrollment logs; compliance with 
the protocol and with the principles of Good Clinical Practice; completion of eCRFs; source data 
verification; study drug accountability and storage; facilities and staff. It is expected that eCRFs 
are completed within the timeframe outlined in the CRF completion guidelines. 
During scheduled monitoring visits, the investigator and the investigational site staff must be 
available to meet with the study monitor in order to discuss the progress of the study, make 
necessary corrections to eCRF entries, respond to data clarification requests and respond to any 
other study-related inquiries of the monitor. 
The clinical monitor has the obligation to follow the study closely. In addition to site visits the 
monitor will maintain necessary telephone, e-mail, and letter contacts as well as ongoing data 
review and query resolution. 
In addition to the above, representatives of local or foreign health authorities may review the 
conduct or results of the study at the investigational site. The investigator must promptly inform 
the PCCTC of any audit requests by health authorities, and will provide Gilead Sciences, Inc. with 
the results of any such audits and with copies of any regulatory documents related to such audits. 
As applicable, in accordance with HIPAA, a patient authorization to use personally identifiable 
health information may be required from each subject before research activities. This 

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Authorization document must clearly specify what parties will have access to a subject’s personal 
health information, for what purpose, and for how long. 
Monitoring and auditing procedures developed by the Sponsor or its designee will be followed, in 
order to comply with GCP guidelines. On-site review of subject’s CRFs for completeness and 
clarity, cross-checking with source documents, and review of regulatory documents will be 
performed. All available source documents should be obtained by the Investigator and provided 
to the Sponsor or designee at each monitoring visit. 
The site monitor will ensure that the investigation is conducted according to protocol design and 
regulatory requirements by frequent communications. 
Regulatory authorities, the IRB/IEC, University of Wisconsin, the PCCTC, and/or Gilead 
Sciences, Inc. clinical quality assurance group or designee may request access to all source 
documents, subject’s CRFs, and other study documentation for on-site audit or inspection. Direct 
access to these documents must be guaranteed by the Investigator, who must provide support at 
all times for these activities. 
9.9 
Patient Data Protection 
Privacy Act Compliance. Information collected in this clinical trial is subject to the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA) as described in 45 CFR 160 and 45 
CFR 164. The study Investigator is responsible for informing subjects of their rights under 
HIPAA, and obtaining any necessary HIPAA authorizations. In compliance with the provisions of 
that policy, Gilead Sciences, Inc. 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 Gilead Sciences, Inc. or designee in connection with the 
development of the study drug. The study Investigator is obliged to provide Gilead Sciences, Inc. 
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, Gilead Sciences, Inc., designee, 
and the IRB/EC for each study site. 
9.10 
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, 
Gilead Sciences, Inc. requests that every Investigator and sub-Investigator mentioned on FDA 
Form 1572 fill out a financial disclosure form. Under the provisions of 21 CFR Part 54, the 
term clinical Investigator includes the spouse and each dependent child of the Investigator. 

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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 (e.g., 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 
to notify Gilead Sciences, Inc. 
To assist Gilead Sciences, Inc. in providing the FDA with the required information, please 
complete the financial disclosure form and return the original signed copy. All information 
provided in the financial disclosure form will be regarded as strictly confidential and will only 
be disclosed to the FDA. 
9.11 
Discontinuation Criteria 
Gilead Sciences, Inc. reserves the right to discontinue the trial 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-Investigator and Gilead Sciences, Inc. As directed 
by the Sponsor-Investigator, all study materials will be collected and all CRFs completed to the 
greatest extent possible. 
10. 
DISSEMINATION AND PUBLICATION OF RESULTS 
The dissemination and publication of the trial results will be a joint decision between Investigators 
of participating institutions and Gilead Sciences, Inc. 

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11. 
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Massard C, Mateo J, Loriot Y, de Bono J. et.al. Phase I/II trial of cabazitaxel plus abiraterone in 
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 Smith M, Hussain M, Parnis F et al. Daralutamide and survival in metastatic, hormone-sensitive 
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APPENDIX A: PERFORMANCE STATUS CRITERIA 
ECOG Performance Status Scale 
Karnofsky Performance Scale 
Grade 
Description 
% 
Description 
0 
Normal activity. Fully active, able to 
continue all predisease performance 
without restriction. 
100 
Normal, no complaints, no evidence of 
disease 
90 
Able to carry on normal activity, minor 
signs or symptoms of disease 
1 
Symptoms, but ambulatory. Restricted in 
physically strenuous activity but 
ambulatory and able to carry out work of a 
light or sedentary nature (e.g., light 
housework, office work). 
80 
Normal activity with effort, some signs or 
symptoms of disease 
70 
Cares for self, unable to carry on normal 
activity or to do active work 
2 
In bed < 50% of the time. Ambulatory and 
capable of all self-care but unable to carry 
out any work activities. Up and about more 
than 50% of waking hours. 
60 
Requires occasional assistance but is able 
to care for most needs 
50 
Requires considerable assistance and 
frequent medical care 
3 
In bed > 50% of the time. Capable of only 
limited self-care, confined to bed or chair 
> 50% of waking hours. 
40 
Disabled, requires special care and 
assistance 
30 
Severely disabled, hospitalization indicated. 
Death not imminent. 
4 
100% bedridden. Completely disabled, 
cannot carry on any self-care, totally 
confined to bed or chair. 
20 
Very sick, hospitalization indicated. Death 
not imminent. 
10 
Moribund, fatal processes progressing 
rapidly 
5 
Dead 
0 
Dead 

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APPENDIX B: STUDY CALENDAR 
 
Cycle = 21 days 
Screening 
Cycle 1 
Cycle 2 
Cycle 3 
Cycle 4+ 
End of Treatment 
/Progression 
Follow-up7 
Within 30 days 
prior to C1D1 
Day 
1 
(±3) 
Day 
8 
(±3) 
Day 
1 
(±3) 
Day 8 
(±3) 
Day 1 
(±3) 
Day 
8 
(±3) 
Day 
15 
(±7) 
Day 
1 
(±3) 
Day 
8 
(±3) 
30 days from last treatment 
(+7) 
Every 3 
months 
(±7) 
Assessments 
Medical History 
& Comorbidities 
X 
X 
X 
X 
X 
Consent 
X 
Physical exam 
and ECOG PS 
X 
X 
X 
X 
X 
X 
Toxicity 
assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signs, 
height, weight1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ECG 
X 
X 
Laboratory Evaluations 
PSA 
X 
X 
X 
X 
X 
X 
X 
X 
Testosterone 
X 
CTCs & plasma 
X 
X 
X 
X 
X 
X2 
X 
Buffy coat 
X 
CBC with 
differential9 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
CMP3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PT/INR and PTT 
X 
X 
Urinalysis4 
X 
Treatment-Experimental Interventions 
Sacituzumab 
Govitecan 
X 
X 
X 
X 
X 
X 
X 
X 

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Metastatic 
Biopsy5 
X 
X 
Imaging studies 
99mTc-MDP bone 
scan6 
X 
X2 
X8 
X 
CT Chest; CT or 
MRI Abdomen/ 
Pelvis6 
X 
X2 
X8 
X 
1Height is only required during screening. BP and pulse prior to first infusion, every 15 for the first hour and then every 30 minutes until completing 
IV administration, at completion, and then additionally 30 minutes later. In absence of significant changes, frequency may be reduced with 
subsequent doses to prior to infusion, at 30 minutes, and then at completion. All time points may be collected ±5 minutes. 
2Every 3 cycles (cycle 7, cycle 10, etc.) or every 9 weeks; if a cycle is delayed, procedures should still be performed every 9 weeks. 
3Sodium, potassium, chloride, bicarbonate, BUN, glucose, creatinine, AST, ALT, alkaline phosphatase, lactate dehydrogenase, total bilirubin, total 
protein, albumin, serum calcium, magnesium, and phosphorous 
4To include pH, specific gravity and hemoglobin, glucose, ketones, and protein by dipstick, with microscopic exam if any of the dipstick analytes are 2+ 
or higher. 
5Fresh or Archived tumor from standard of care biopsy from metastatic site required for enrollment. On study biopsy at cycle 3 day 15 should be 
performed, regardless of treatment delays, to be performed in line with CT and bone scans. 
6Window extended to ±10 days for scans. 
7All subjects should have adverse events evaluated at least 30 days from the last dose of study drug. Follow-up for progression will be performed every 
3 months or per standard of care for up to 2 years from initiation of study therapy if subjects discontinue study treatment prior to progression. For 
subjects coming off-treatment due to progression, follow-up is complete once AEs have been evaluated at least 30 days after the last dose of the study 
drug. 
8If not performed within 30 days of End of Treatment/Progression 
9 If lab values are not within normal range on day 1 or day 8, consider repeat CBC with differential on day 15, as per MD discretion. In the case of a 
Grade 3 ANC subjects should be assessed weekly and for grade 4 ANC subjects should be assessed bi-weekly as per section 6.4.1. 

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APPENDIX C: ELEMENTS OF INFORMED CONSENT 
Signed studies items: informed consent will be obtained from all subjects participating in clinical research 
or the subject’s legally authorized representative. This consent must include the following: 
• 
A statement that the study involves research and an explanation of the purposes of the research; 
a description of the procedures to be followed and identification of any procedures that are 
experimental; and the expected duration of the subject’s participation. 
• 
A description of any reasonably foreseeable risks or discomforts to the subject. 
• 
A description of any benefits to the subject or to others that may reasonably be expected from 
the research. If the subject is to be paid for participating in the study, the consent form must state 
the amount he/she will receive and the schedule of payment (to assure neither coercion nor 
undue influence). 
• 
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be 
advantageous to the subject. 
• 
A statement describing the extent, if any, to which confidentiality of records identifying the 
subject will be maintained and noting the possibility that regulatory agencies, the IRB, or an 
authorized contract research organization (CRO) may inspect the records. 
• 
For research involving more than minimal risk, an explanation of whether any medical treatment 
is available if injury occurs and, if so, what it consists of, or where further information may be 
obtained. 
• 
An explanation of whom to contact, including the appropriate telephone number, for answers to 
pertinent questions about the research and research subject’s rights, and whom to contact in the 
event of a research-related injury to the subject. (NOTE: In some cases it may be necessary to 
identify some person other than the investigator as the contact. The guidance of the IRB may be 
required.) 
• 
A statement that participation is voluntary, that refusal to participate will involve no penalty or 
loss of benefits to which the subject is otherwise entitled, and that the subject 
• 
A copy of the consent form given to the subject. 
• 
A statement of consent, e.g. "I agree to participate." 
• 
A place for signature and date of signature for the research subject. 
• 
A statement that the particular treatment or procedures may involve risks to the subject (or to 
the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable. 
• 
Anticipated circumstances under which the subject’s participation may be terminated by the 
investigator without regard to the subject's consent. 
• 
Any additional costs to the subject that may result from participation in the research. 
• 
The consequences of a subject’s decision to withdraw from the research and procedures for 
orderly termination of participation by the subject. 
• 
A statement that significant new findings developed during the course of the research that may 
relate to the subject's willingness to continue participation will be provided to the subject. 
• The approximate number of subjects involved in the study. 

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APPENDIX D: THE DECLARATION OF HELSINKI 
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research 
Involving Human Patients 
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 
29th WMA General Assembly, Tokyo, Japan, October 1975, 35th WMA General Assembly, Venice, Italy, 
October 1983, 41st WMA General Assembly, Hong Kong, September 198948th WMA General Assembly, 
Somerset West, Republic of South Africa, October 1996 52nd WMA General Assembly, Edinburgh, 
Scotland, October 2000 
53rd WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 added) 55th WMA 
General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added) 59th WMA General 
Assembly, Seoul, October 2008 
 
A. INTRODUCTION 
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement 
of ethical principles for medical research involving human patients, including research on 
identifiable human material and data. The Declaration is intended to be read as a whole and each 
of its constituent paragraphs should not be applied without consideration of all other relevant 
paragraphs. 
2. Although the Declaration is addressed primarily to physicians, the WMA encourages other 
participants in medical research involving human patients to adopt these principles. 
3. It is the duty of the physician to promote and safeguard the health of patients, including those 
who are involved in medical research. The physician's knowledge and conscience are dedicated 
to the fulfillment of this duty. 
4. The Declaration of Geneva of the WMA binds the physician with the words, "The health of my 
patient will be my first consideration," and the International Code of Medical Ethics declares that, 
"A physician shall act in the patient's best interest when providing medical care." 
5. Medical progress is based on research that ultimately must include studies involving human 
patients. Populations that are underrepresented in medical research should be provided 
appropriate access to participation in research. 
6. In medical research involving human patients, the well-being of the individual research patient 
must take precedence over all other interests. 
7. The primary purpose of medical research involving human patients is to understand the causes, 
development and effects of diseases and improve preventive, diagnostic and therapeutic 
interventions (methods, procedures and treatments). Even the best current interventions must 
be evaluated continually through research for their safety, effectiveness, efficiency, accessibility 
and quality. 
8. In medical practice and in medical research, most interventions involve risks and burdens. 
9. Medical research is patient to ethical standards that promote respect for all human patients and 
protect their health and rights. Some research populations are particularly vulnerable and need 
special protection. These include those who cannot give or refuse consent for themselves and 
those who may be vulnerable to coercion or undue influence. 

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10. Physicians should consider the ethical, legal and regulatory norms and standards for research 
involving human patients in their own countries as well as applicable international norms and 
standards. No national or international ethical, legal or regulatory requirement should reduce or 
eliminate any of the protections for research patients set forth in this Declaration. 
 
B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH 
1. It is the duty of physicians who participate in medical research to protect the life, health, dignity, 
integrity, right to self-determination, privacy, and confidentiality of personal information of 
research patients. 
2. Medical research involving human patients must conform to generally accepted scientific 
principles, be based on a thorough knowledge of the scientific literature, other relevant sources 
of information, and adequate laboratory and, as appropriate, animal experimentation. The 
welfare of animals used for research must be respected. 
3. Appropriate caution must be exercised in the conduct of medical research that may harm the 
environment. 
4. The design and performance of each research study involving human patients must be clearly 
described in a research protocol. The protocol should contain a statement of the ethical 
considerations involved and should indicate how the principles in this Declaration have been 
addressed. The protocol should include information regarding funding, sponsors, institutional 
affiliations, other potential conflicts of interest, incentives for patients and provisions for treating 
and/or compensating patients who are harmed as a consequence of participation in the research 
study. The protocol should describe arrangements for post-study access by study patients to 
interventions identified as beneficial in the study or access to other appropriate care or benefits. 
5. The research protocol must be submitted for consideration, comment, guidance and approval to 
a research ethics committee before the study begins. This committee must be independent of the 
researcher, the sponsor and any other undue influence. It must take into consideration the laws 
and regulations of the country or countries in which the research is to be performed as well as 
applicable international norms and standards but these must not be allowed to reduce or 
eliminate any of the protections for research patients set forth in this Declaration. The committee 
must have the right to monitor ongoing studies. The researcher must provide monitoring 
information to the committee, especially information about any SAEs. No change to the protocol 
may be made without consideration and approval by the committee. 
6. Medical research involving human patients must be conducted only by individuals with the 
appropriate scientific training and qualifications. Research on patients or healthy volunteers 
requires the supervision of a competent and appropriately qualified physician or other health care 
professional. The responsibility for the protection of research patients must always rest with the 
physician or other health care professional and never the research patients, even though they 
have given consent. 
7. Medical research involving a disadvantaged or vulnerable population or community is only 
justified if the research is responsive to the health needs and priorities of this population or 
community and if there is a reasonable likelihood that this population or community stands to 
benefit from the results of the research. 
8. Every medical research study involving human patients must be preceded by careful assessment 
of predictable risks and burdens to the individuals and communities involved in the research in 
comparison with foreseeable benefits to them and to other individuals or communities affected 
by the condition under investigation. 

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9. Every clinical study must be registered in a publicly accessible database before recruitment of the 
first patient. 
10. Physicians may not participate in a research study involving human patients unless they are 
confident that the risks involved have been adequately assessed and can be satisfactorily 
managed. Physicians must immediately stop a study when the risks are found to outweigh the 
potential benefits or when there is conclusive proof of positive and beneficial results. 
11. Medical research involving human patients may only be conducted if the importance of the 
objective outweighs the inherent risks and burdens to the research patients. 
12. Participation by competent individuals as patients in medical research must be voluntary. 
Although it may be appropriate to consult family members or community leaders, no competent 
individual may be enrolled in a research study unless he or she freely agrees. 
13. Every precaution must be taken to protect the privacy of research patients and the confidentiality 
of their personal information and to minimize the impact of the study on their physical, mental 
and social integrity. 
14. In medical research involving competent human patients, each potential patient must be 
adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, 
institutional affiliations of the researcher, the anticipated benefits and potential risks of the study 
and the discomfort it may entail, and any other relevant aspects of the study. The potential patient 
must be informed of the right to refuse to participate in the study or to withdraw consent to 
participate at any time without reprisal. Special attention should be given to the specific 
information needs of individual potential patients as well as to the methods used to deliver the 
information. After ensuring that the potential patient has understood the information, the 
physician or another appropriately qualified individual must then seek the potential patient's 
freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, 
the non-written consent must be formally documented and witnessed. 
15. For medical research using identifiable human material or data, physicians must normally seek 
consent for the collection, analysis, storage and/or reuse. There may be situations where consent 
would be impossible or impractical to obtain for such research or would pose a threat to the 
validity of the research. In such situations the research may be done only after consideration and 
approval of a research ethics committee. 
16. When seeking informed consent for participation in a research study the physician should be 
particularly cautious if the potential patient is in a dependent relationship with the physician or 
may consent under duress. In such situations the informed consent should be sought by an 
appropriately qualified individual who is completely independent of this relationship. 
17. For a potential research patient who is incompetent, the physician must seek informed consent 
from the legally authorized representative. These individuals must not be included in a research 
study that has no likelihood of benefit for them unless it is intended to promote the health of the 
population represented by the potential patient, the research cannot instead be performed with 
competent persons, and the research entails only minimal risk and minimal burden. 
18. When a potential research patient who is deemed incompetent is able to give assent to decisions 
about participation in research, the physician must seek that assent in addition to the consent of 
the legally authorized representative. The potential patient's dissent should be respected. 
19. Research involving patients who are physically or mentally incapable of giving consent, for 
example, unconscious patients, may be done only if the physical or mental condition that prevents 
giving informed consent is a necessary characteristic of the research population. In such 
circumstances the physician should seek informed consent from the legally authorized 
representative. If no such representative is available and if the research cannot be delayed, the 

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study may proceed without informed consent provided that the specific reasons for involving 
patients with a condition that renders them unable to give informed consent have been stated in 
the research protocol and the study has been approved by a research ethics committee. Consent 
to remain in the research should be obtained as soon as possible from the patient or a legally 
authorized representative. 
20. Authors, editors and publishers all have ethical obligations with regard to the publication of the 
results of research. Authors have a duty to make publicly available the results of their research on 
human patients and are accountable for the completeness and accuracy of their reports. They 
should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as 
positive results should be published or otherwise made publicly available. Sources of funding, 
institutional affiliations and conflicts of interest should be declared in the publication. Reports of 
research not in accordance with the principles of this Declaration should not be accepted for 
publication. 
 
C. ADDITIONAL PRINCIPLES FORMEDICAL RESEARCH COMBINED WITH MEDICAL CARE 
1. The physician may combine medical research with medical care only to the extent that the 
research is justified by its potential preventive, diagnostic or therapeutic value and if the physician 
has good reason to believe that participation in the research study will not adversely affect the 
health of the patients who serve as research patients. 
2. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those 
of the best current proven intervention, except in the following circumstances: 
a. The use of placebo, or no treatment, is acceptable in studies where no current proven 
intervention exists; or 
b. Where for compelling and scientifically sound methodological reasons the use of placebo 
is necessary to determine the efficacy or safety of an intervention and the patients who 
receive placebo or no treatment will not be patient to any risk of serious or irreversible 
harm. Extreme care must be taken to avoid abuse of this option. 
3. At the conclusion of the study, patients entered into the study are entitled to be informed about 
the outcome of the study and to share any benefits that result from it, for example, access to 
interventions identified as beneficial in the study or to other appropriate care or benefits. 
4. The physician must fully inform the patient which aspects of the care are related to the research. 
The refusal of a patient to participate in a study or the patient's decision to withdraw from the 
study must never interfere with the patient-physician relationship. 
In the treatment of a patient, where proven interventions do not exist or have been ineffective, the 
physician, after seeking expert advice, with informed consent from the patient or a legally authorized 
representative, may use an unproven intervention if in the physician's judgment it offers hope of saving 
life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the 
object of research, designed to evaluate its safety and efficacy. In all cases, new information should be 
recorded and, where appropriate, made publicly available. 

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APPENDIX E: PROSTATE CANCER WORKING GROUP 2 (PCWG2) REPONSE CRITERIA 
The effects of Sacituzumab Govitecan will be assessed using both “control/ relieve/ eliminate” endpoints 
as well as “prevent/ delay” endpoints as outlined in the PCWG2 response criteria summarized in the table 
below. 
 
Variable 
PCWG2 (2007) 
PSA 
Recognize that a favorable effect on PSA may be delayed for 9 weeks or more, even for a 
cytotoxic drug 
Monitor PSA by cycle but plan to continue through early rises for a minimum of 9 weeks 
unless other evidence of progression 
Ignore early rises (prior to 9 weeks) in determining PSA response 
For control/relieve/eliminate endpoints: 
Record the percent change from baseline (rise or fall) at 9 weeks, and separately, the 
maximal change (rise or fall) at any time using a waterfall plot 
For prevent/ delay (progression): Decline from baseline: Record time from start of 
therapy to first PSA increase that is > 25% and > 2 ng/ml above the nadir, and which is 
confirmed by a second value 3 or more weeks later (i.e., a confirmed rising trend). 
No decline from baseline: PSA progression > 25% and > 2 ng/ml after 9 weeks 
Soft-tissue 
lesions 
For control/relieve/ eliminate endpoints: Use RECIST with caveats: 
Only report changes in lymph nodes that were > 2 cm in diameter at baseline 
Record changes in nodal and visceral soft tissue sites separately 
Record complete elimination of disease at any site separately 
Confirm favorable change with second scan 
Record changes using waterfall plot 
For prevent/ delay endpoints (progression): Use RECIST criteria for progression, with 
additional requirement that progression at first assessment be confirmed by a second scan 
6 or more weeks later. 
Note that for some treatments, a lesion may increase in size before it decreases 
Bone 
For control/relieve/ eliminate endpoints: Record outcome as new lesions or no new 
lesions First scheduled re-assessment: No new lesions: continue therapy; 
New lesions: perform a confirmatory scan 6 or more weeks later 
Confirmatory scan: No new lesions: continue therapy; Additional new lesions: progression 
Subsequent scheduled re-assessments: No new bone lesions: continue; New lesions: 
progression 
For prevent/ delay endpoints (progression): The appearance of > 2 new lesions, and for 
the first reassessment only, a confirmatory scan performed 6 or more weeks later that 
shows a minimum of 2 or more additional new lesions. 
The date of progression is the date of the first scan that shows the change. 
Symptoms 
Consider independently of other outcome measures; Document pain and analgesia at entry 
with a lead in period and measure repeatedly at 3- to 4- week intervals; Perform serial 
assessments of global changes in HRQOL, urinary or bowel compromise, pain management, 
additional anticancer therapy; Ignore early changes (< 9 weeks)in pain or HRQOL in absence 
of compelling evidence of disease progression; Confirm response or progression of pain or 
HRQOL end points > 3 weeks later 
* Adapted from Scher et al, 2008 

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APPENDIX F: GLOSSARY OF ABBREVIATIONS AND ACRONYMS 
 
ACTH 
adrenocorticotrophic hormone 
ADC 
antibody-drug conjugate 
ADCC 
antibody-dependent cell-mediated cytotoxicity 
ADR 
adverse drug reaction 
ADT 
androgen deprivation therapy 
AE 
adverse event 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil counts 
AR 
androgen receptor 
ARSI 
Androgen Receptor Signaling Inhibitors 
AST 
aspartate aminotransferase 
BUN 
blood urea nitrogen 
CBC 
complete blood count 
CBR 
clinical benefit rate (%OR+SD) 
CDR 
complementarity-determining region 
CFR 
Code of Federal Regulation 
CMP 
comprehensive medical panel 
CNS 
central nervous system 
CR 
complete response 
CRF 
case report form 
CRPC 
castration-resistant prostate cancer 
CT 
computerized tomography 
CTC 
circulating tumor cells 
CTCAE 
common terminology criteria for adverse events 
ctDNA 
circulating DNA 
CYP17 
cytochrome P450 
D 
day 
DHEA-S 
dehydroepiandrosterone-sulfate 
17A1 DHEA 
dehydroepiandrosterone 
dL 
deciliter 
DLT 
dose limiting toxicity 
DNA 
deoxyribonucleic acid 
DT 
dose titration 
ECG 
electrocardiogram 
ECOG 
eastern cooperative oncology group 
EU 
European Union 
FDA 
Food and Drug Administration 
FISH 
fluorescent in situ hybridization 
GCP 
good clinical practice 
GLP 
good laboratory practice 

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GR 
glucocorticoid receptor 
HAHA 
human anti-human antibodies 
HCT 
hematocrit 
HDPE 
high density polyethylene 
hERG 
human Ether-a-go-go-related gene 
HGB 
hemoglobin 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICH 
International Committee on Harmonization 
IC50 
half–maximal inhibitory concentration 
ICF 
informed consent form 
IEC 
independent ethics committee 
IgG 
immunoglobulin G 
IND 
Investigational New Drug 
INR 
international normalized ratio 
IRB 
institutional review board 
IULN 
institutional upper limit of normal 
HIV 
human immunodeficiency virus 
K 
potassium 
Kg 
kilogram 
L 
Liter 
LDH 
lactate dehydrogenase 
LHRH 
luteinizing hormone–releasing hormone 
mAb 
monoclonal antibody 
mEq 
milliequivalent 
mg 
milligram 
mL 
milliliter 
µl 
microliter 
MRI 
magnetic resonance Imaging 
MTD 
maximum tolerated dose 
NCI 
National Cancer Institute 
ng 
naogram 
NSAE 
non-serious adverse event 
NSAID 
non-steroidal anti-inflammatory drug 
NOAEL 
No-observed –adverse –effect level 
NOEL 
no-observed–effect level 
NYHA 
New York Heart Association 
OR 
Objective Response, OR = CR + PR 
OS 
overall survival 
PCWG2 
prostate cancer working group 2 
PD 
pharmacodynamics 
PFS 
progression free survival 
PK 
pharmacokinetics 
PR 
partial response 

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PSA 
prostate specific antigen 
PT 
prothrombin time 
PTT 
partial prothrombin time 
QD 
once a day 
QTcF 
QT interval corrected by Fredericia correction formula 
RBC 
red blood cell 
RECIST 
response evaluation criteria in solid tumors 
RNA 
ribonucleic acid 
rPFS 
radiological progression free survival 
SAE 
serious adverse event 
SOP 
standard operating procedure 
TTP 
time to progression 
WBC 
white blood cell 
ULN 
upper limit of normal 
US 
United States of America 
UWCCC 
University of Wisconsin Carbone Cancer Center