Clinical trial NCT03899467
Conditions: Metastatic Castrate Resistant Prostate Cancer (mCRPC) Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Sponsor: Suzhou Kintor Pharmaceutical Inc,
Start date: 2019-05-30; Completion date: 2022-09-19
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multiple-center, open-label, randomized, daily dose, two-sequence, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide treatment.

The objective of the study is to evaluate the safety and tolerability of proxalutamide and determine the RP2D for Ph III and/or other confirming studies.

Subjects will be randomized into the 2 treatment arms.

Detailed description:
This study is an open-label, randomized, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide. All subjects will be randomized to take 400 mg or 500 mg of GT0918 by oral administration once daily on an empty stomach (2-3 hours after a meal) for initial treatment of 6 months. Randomization of subjects will be stratified by prior therapy (abiraterone or enzalutamide).

Subjects will continue treatment with GT0918 (proxalutamide) at their assigned dose on an empty stomach until disease progression, intolerable toxicities (AEs), or withdrawn consent. A post-treatment period of 4 weeks will commence that concludes with an end-of-study visit.

Disease progression will be assessed by three methods over the duration of the study. Subjects will be assessed for biochemical (PSA) progression measured monthly, as well as radiographic progression by CT scan or/and bone progression by radionuclide bone scan every 12-weeks. Progressive disease will be considered on the occurrence of the first assessed progression event. Subjects with PSA progression only may continue the study until radiographic or bone progression at the discretion of the Investigator and with agreement by the sponsor or their authorized medical monitor.

Arms: arm 1: Group 1: Post enzalutamide failure

Group 2: Post abiraterone failure arm 2: Group 1: Post enzalutamide failure

Group 2: Post abiraterone failure
Interventions: intervention 1: GT0918
Intervention descriptions: intervention 1: anti-tumor activity

Protocol documents:
Prot_SAP_000.pdf: 
Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 1 of 79 
An Expanded/Phase II, Multi-Center, Randomized, Open-Label 
Study to Evaluate the Safety and Tolerability of Proxalutamide 
(GT0918) in Subjects with Metastatic Hormone Sensitive Prostate 
Cancer (mHSPC) and Metastatic Castrate Resistant Prostate 
Cancer (mCRPC) who Failed Either Abiraterone or Enzalutamide  
 
Protocol Number: 
GT0918-US-1002 - expanded/phase II 
 
Study Drug:  
Proxalutamide (GT0918)   
IND Number: 
124616 
Study Sponsor: 
Suzhou Kintor Pharmaceutical, Inc. 
Legal Registered Address:  
1011 S. Hamilton Rd. 
Chapel Hill. North Carolina.  
United States. 27517. 
 
 
 
 
Protocol Version:  
V 5.0 
 
 
Confidential and Proprietary 
 
This document contains proprietary and confidential information of Suzhou Kintor 
Pharmaceutical, Inc.  Acceptance of this document constitutes agreement by the recipient that 
no unpublished information contained within will be published or disclosed without prior 
written approval from Suzhou Kintor Pharmaceutical, Inc. except that this document may be 
disclosed to study personnel under your supervision who need to know the contents for 
conducting the study, and appropriate Institutional Review Boards/Independent Ethics 
Committees under the condition that they are requested to keep it confidential.  The foregoing 
shall not apply to disclosure required by governmental regulations or laws, however; Suzhou 
Kintor Pharmaceutical, Inc. must be promptly informed of any such disclosure.   
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 2 of 79 
Sponsor Signature Page 
 
Protocol title: An Expanded/Phase II, Multi-Center, Randomized, Open-Label Study to 
Evaluate the Safety and Tolerability of Proxalutamide (GT0918) in Subjects 
with Metastatic Hormone Sensitive Prostate Cancer (mHSPC) and Metastatic 
Castrate Resistant Prostate Cancer (mCRPC) who Failed Either Abiraterone or 
Enzalutamide 
 
Protocol No.: 
GT0918-US-1002 
Version: 
5.0 
Sponsor:  
Suzhou Kintor Pharmaceuticals, Inc. 
 
We, the undersigned, have read this protocol and agree that it contains all necessary information 
required to conduct the trial and that the protocol is in compliance with International 
Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines. 
 
Sponsor’s Authorized Representative & Medical Expert: 
 
 
_________________________________            
 
 (Signature)  
Date (DD-MMM-YYYY) 
Xunwei Dong, M.D. Ph.D  
Chief Medical Officer 
Suzhou Kintor Pharmaceuticals, Inc. 
 
 
 
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SIGN


Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 3 of 79 
Investigator Agreement 
 
I confirm that I have read and understood this protocol and agree to conduct this study as outlined in the 
protocol and other information supplied to me.  I agree to conduct this study in compliance with Good 
Clinical Practice (GCP) standards as defined by the International Conference on Harmonization (ICH) 
Guideline for Good Clinical Practice, the ethical principles of the Declaration of Helsinki, all applicable 
national, state and local regulations, as well as the requirements of the appropriate Institutional Review 
Board (IRB)/Independent Ethics Committee (IEC) and any other institutional requirements. 
 
 
Principal Investigator: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name (please type or print) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Institution 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Address 
 
 
 
 
 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 4 of 79 
CONTACT LIST 
Sponsor: 
Suzhou Kintor Pharmaceuticals, Inc. 
Legal address: 
1011 S. Hamilton Rd. 
Chapel Hill. North Carolina.  
United States. 27517. 
Contract Research Organization 
Medical Director: 
 
Carlyle A. St. Paul, MD 
Syneos Health Inc 
1030 Sync Street 
Morrisville, NC 27560 
Telephone:  301-806-6651 
Email: carlyle.st.paul@syneoshealth.com 
Sponsor’s Responsible Clinical 
Representative: 
 
Ting Huang, PhD 
Kintor Pharmaceuticals, Inc. USA 
1011 S. Hamilton Rd. 
Chapel Hill, NC 27517 
Telephone: 984-208-1255 
Contract Research Organization (CRO) 
Study Manager: 
 
Siechieh Redd  
Syneos Health 
1030 Sync Street 
Morrisville, NC 27560 
Telephone:  919-604-4974 
CRO Safety (Pharmacovigilance) 
Reporting: 
Syneos Health 
To report an SAE please send the 
documentation via email to:  
INCDrugSafety@INCResearch.com 
or 
Global Safety Fax: +1 (877) 464-7787  
Clinical Laboratory (ctDNA/ctRNA - 
Exploratory Markers): 
Jianjun Yu, PhD  
Predicine US 
3555 Arden Road 
Hayward, CA 94545 
Telephone: 408-645-9128 
Clinical Laboratory (Circulating Tumor 
Cell (CTC) Samples): 
Lincy Chu, PhD 
Alliance Manager, Clinical  
Operations, Translational Research 
EPIC SCIENCES  
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 5 of 79 
9381 Judicial Drive, Suite 200 
San Diego, CA 92121 
Direct: 858-256-7640 
Office: 858-356-6610 ext. 227 
Email: lincy.chu@epicsciences.com  
 
 
 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 6 of 79 
SUMMARY OF CHANGES 
 
GT0918-US-1002 Protocol Version 5.0, changes below have been made to respond to questions 
and comments from investigational sites. 
 
1. To add additional 6 cycles to current treatment duration to extend the treatment duration 
to 30 cycles, per subject’s willing and investigators’ discretion.  
 
2. Disease Assessment scans (CT or MRI or bone scan) is added with Cycle 27 D28 and 
Cycle 30 D28. 
3. Complete Physical Exam is added with Cycle 27 D28 and Cycle 30 D28 
4. Abbreviated Physical Exam is added with Cycle 26 Day 1, Cycle 27 Day1, Cycle 29 Day 
1, Cycle 30 Day 1.  
5. 12-lead ECG is added with Cycle 25 Day 1 and Cycle 28 Day 1. 
6. Exploratory markers test is added with Cycle 25 Day 1 and Cycle 28 Day 1. 
 
7. Change Kintor Legal address is updated to 1011 S. Hamilton Rd. Chapel Hill. North 
Carolina, United States. 27517 
 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 7 of 79 
1 SYNOPSIS (EXPANDED/PHASE II) 
Name of Sponsor/Company: Suzhou Kintor Pharmaceutical, Inc. 
Name of Investigational Product: Proxalutamide (GT0918) 
Title of Study:  
An Expanded/Phase II, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and 
Tolerability of Proxalutamide (GT0918) in Subjects with Metastatic Hormone Sensitive Prostate 
Cancer (mHSPC) or Metastatic Castrate Resistant Prostate Cancer (mCRPC) who Failed Either 
Abiraterone or Enzalutamide  
Study period:  
Date first subject enrolled: 2Q2019   
Phase of development (2nd stage): Expanded/Phase II 
Objectives (Expanded/Phase II):  
Primary: 
 
Evaluate the safety and tolerability of GT0918 in subjects with mHSPC or mCRPC who failed 
either abiraterone or enzalutamide treatment and determine the Recommendation Phase II Dose 
(RP2D) for other Phase II or III studies.  
Secondary: 
 
To evaluate radiographic progression-free survival (rPFS) 
 
To evaluate objective response rate  
 
To evaluate time to radiographic progression 
 
To evaluate Prostate Surface Antigen (PSA) 50% decline and maximum change at 12 weeks 
 
To evaluate PSA doubling time (PSA DT) 
 
To evaluate the time to PSA progression 
 
To identify exploratory biomarkers to characterize androgen receptor (AR) inhibition and/or 
down-regulation by GT0918  
 
Study Design (Expanded/Phase II): 
This study is an open-label, randomized, expanded/phase II study in subjects with mHSPC or mCRPC 
who progressed after either abiraterone or enzalutamide treatment. All subjects will be randomized to 
take 400 mg or 500 mg of GT0918 by oral administration once daily on an empty stomach (2-3 hours 
after a meal) for initial treatment of 6 months. Randomization of subjects will be stratified by prior 
therapy (abiraterone or enzalutamide). 
 
Subjects will continue treatment with GT0918 for up to 24 additional cycles (total up to 30 cycles) at 
their assigned dose on an empty stomach until disease progression, intolerable toxicities/adverse events 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 8 of 79 
(AEs), or withdrawn consent. Subjects will end the study by completing the end of study (EOS) 
visit/assessment. The safety follow-up visit will occur 30 days after the last does. Any subject with 
drug related AE or SAE will be followed until resolution or the subject’s condition stabilizes, which 
comes first. The safety follow-up visit can be performed via phone or in clinic as required.  
 
Disease progression will be assessed by three methods as follow over the duration of the study.  
1) Clinical assessment 
2) Biochemical (PSA) progression measured every 4 weeks 
3) Radiographic progression by CT scan and/or bone progression by radionuclide bone scan 
every 12 weeks 
Progressive disease will be considered on the occurrence of the first assessed progression event. For 
subjects with PSA progression may continue on study drug until radiographic and/or clinical 
progression, at the discretion of the Investigator and with the Medical Monitor agreement. A treatment 
diagram for the study is provided below in Figure 1. 
FIGURE 1 
 
Biomarker Assessment: 
Subjects will have blood drawn for circulating tumor cells (CTC), ct-DNA and ct-RNA obtained at 
baseline and every 12 weeks during the study, all subjects on study drug over 20 weeks (over 3 time 
points) will be analyzed for these tumor biomarkers.   
 
mCRPC or 
mHSPC
n=60
Failed to 
Abiraterone or 
Enzalutamide
Arm 1: 400 mg/day
(N=30)
Arm 2: 500 mg/day
(N=30)
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 9 of 79 
Planned number of subjects: 60 (30 subjects per treatment arm) as displayed in Figure 1:  
ARM1: 400mg /day of GT0918 
Group 1: Post enzalutamide (N=15) 
Group 2: Post abiraterone (N=15) 
ARM 2: 500 mg/day of GT0918 
Group 1: Post enzalutamide (N=15) 
Group 2: Post abiraterone (N=15) 
Study center(s):  
10 study centers located in the United States. 
Diagnosis and Inclusion/Exclusion criteria (expanded/phase II): 
Inclusion criteria: 
1. Signed informed consent obtained prior to any study-related procedure being performed. 
2. Subjects at least 18 years of age or older at the time of consent. 
3. Subjects with histologically confirmed mHSPC or mCRPC who received abiraterone or 
enzalutamide for the hormonal treatment of 6 month or longer.  
4. Subjects with mHSPC are required to have no prior ADT (androgen deprivation therapy) or 
orchiectomy. For mCRPC, ongoing androgen deprivation therapy with a luteinizing hormone-
releasing hormone (LHRH) “super-agonist” or antagonist, or bilateral orchiectomy. Serum 
testosterone level is < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening. 
5. Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging 
(MRI) or bone scan. 
6. Progressive disease despite hormonal treatment with abiraterone or enzalutamide for over 6 
months (but not both).  However, if either abiraterone or enzalutamide were used less than 3 
months before discontinuation due to toxicity, the subject is eligible. Progressive disease is 
defined by 1 or more of the following criteria: 
a. Subjects with a rising prostate specific antigen (PSA) value > 2 ng/mL in at least 2 
measurements, at least 1 week apart. If the confirmatory PSA value is less than the 
screening PSA value, then an additional test for the rising PSA is required to 
document progression. 
b. Subjects with measurable disease, progression defined by Response Evaluation 
Criteria in Solid Tumors (RECIST) 1.1 criteria 
c. Subjects with metastatic bone disease, progression defined by 2 or more new lesions 
in a radionuclide bone scan. 
7. ECOG performance status of 0-1  
8. Screening blood counts of the following: 
a. Absolute neutrophil count ≥ 1500/μL 
b. Platelets ≥ 100,000/μL 
c. Hemoglobin > 9 g/dL (if asymptomatic). 
9. Screening chemistry values of the following: 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 10 of 79 
a. Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit 
of the normal reference range (ULN) 
b. Total bilirubin ≤ 2 × ULN 
c. Creatinine ≤ 1.5 × ULN 
d. Albumin > 2.8 g/dL.  
10. At screening, life expectancy of at least 6 months. 
11. Subjects whose partners are women of childbearing potential (WOCBP) must use an adequate 
method of birth control while on study drug and for at least 3 months after discontinuation of 
study drug. 
12. Subject is willing and able to comply with all protocol required visits and assessments. 
 
Exclusion criteria: 
1. Discontinuation of enzalutamide or abiraterone less than 3 weeks prior to the start of study 
medication.  
2. Prior chemotherapy and experimental therapy (Poly (ADP-ribose) polymerase (PARP) or 
checkpoint inhibitor)  
3. Ongoing acute treatment-related toxicity associated with a previous therapy greater than grade 
1 except for grade 2 alopecia or neuropathy. 
4. History of impaired adrenal gland function (e.g., Addison’s disease, Cushing’s syndrome). 
5. Known gastrointestinal disease or condition that affects the absorption of GT0918. 
6. History of congestive heart failure New York Heart Association (NYHA) class III or IV or 
uncontrolled hypertension at screening. 
7. History or family history of long QT syndrome, or ECG corrected QT interval equal to and 
over 500 ms (Common Terminology Criteria for Adverse Events (CTCAE) V 4.03 grade 2) at 
baseline. 
8. History of other malignancy within the previous 3 years, except basal cell or squamous cell 
carcinoma, or non-muscle invasive bladder cancer. 
9. Use of systemic glucocorticoid (e.g., prednisone, dexamethasone) within 14 days prior to the 
start of study medication. Inhaled or topical steroids are allowed. 
10. Co-administration of CYP3A4 ligands that serve as substrates or induce or inhibit the enzyme 
(See Appendix 4 for the list of medications). If some medication needs to be used for the 
chronic illness, the medication shall be changed to another one that is not on the list or the 
dose should be reduced, at the discretion of the Investigator.  
11. Prior use of any herbal products known to decrease PSA levels (e.g., PC-SPES or saw 
palmetto) within 30 days prior to the start of study medication. 
12. Major surgery within 30 days prior to the start of study medication. 
13. Blood transfusion (including blood products) within 1 week of screening. 
14. Serious persistent infection within 14 days prior to the start of study medication. 
15. Serious concurrent medical condition including CNS disorders. 
16. Previous history of difficulty swallowing capsules or tablets. 
17. Known hypersensitivity to GT0918 or its excipients (See Appendix 5 for drug details). 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 11 of 79 
18. Any condition that, in the opinion of the investigator, would impair the subject’s ability to 
comply with study procedures. 
Investigational product, dosage and mode of administration:  
GT0918 will be provided as 100 mg tablet for oral administration daily. The dose consumption is 
either 400 or 500 mg, once a day (QD), dependent on randomization. 
Reference product, dosage and mode of administration  
No reference product will be used. 
Duration of study (expanded/phase II):  
The part II study will have 3 periods, screening, treatment and post-treatment safety follow up. The 
screening period is up to 3 weeks. The treatment period includes first 6-cycle treatment and potential 
additional cycles for eligible subjects up to 24 cycles. After the first 6 cycles of treatment, subjects 
without progressive disease (PD) may continue GT0918 treatment with the approval of the investigator 
and sponsor; treatment can continue until a subject experience an intolerable adverse event (AE) or 
bone or radiographic disease progression, withdraws consent or termination of the study by the 
sponsor. This approval is required for entering the next 6 cycle treatments (for starting on C7D1, 
C13D1, C19D1, C25D1). All subjects will have End-of-study visit over 30 days after last dose. A post-
treatment safety window of 30 days is allowed for record of any possible delayed study drug-related 
AEs and SAEs after the last dose of study medication.  
 
Criteria for evaluation (expanded/phase II): 
Safety monitoring: 
Toxicity reported during the study will be graded according to the CTCAE v4.03. Laboratory 
Assessments will include PSA, blood chemistry, hematology, lipid profiles, ECGs, and urinalysis. 
 
Safety and tolerability data will be reviewed on an ongoing basis in order to make decisions for dose 
selection and safety management. The following will be promptly reported to the assigned Medical 
Monitor from Sponsor: 
a. SAEs, within 24 hours 
b. AEs resulting in permanent discontinuation from study, regardless of seriousness or relationship 
to study drug. 
c. Treatment modifications (i.e., dose discontinuation, temporary interruption, or dose reduction). 
Dose modification is allowed for this trial. Subjects may skip or discontinue treatment if they 
experience at least one of the following adverse events that are considered by the Investigator 
to be “possibly”, “probably” or “definitely” related to study drug. Treatment modifications 
will be made based on the specified criteria: 
1) For any subjects experiencing grade 3 or 4 hematologic or biochemical toxicity, study drug 
will be temporarily interrupted until toxicity resolves to grade 1 or better 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 12 of 79 
2) For any subjects experiencing grade 2 non-hematologic toxicity with significant impact on 
subject’s daily active life, such as asthenic condition (including asthenia and fatigue), 
hepatoxicity mental impairment and anxiety, study drug will be temporally interrupted until 
toxicity resolves to grade 1 or better 
3) If the Investigator considers that continuing study drug is clinically beneficial for the 
subjects, the treatment and dose can be resumed. For some subjects if dose reduction is safe 
and clinically appropriate, a dose range of 25-50% dose reduction from original starting 
dose can be considered. The dose modification and schedule must be discussed with the 
medical monitor prior to implementation. Possible dose reductions are proposed as follow. 
i. For dose cohort of 400mg: starting dose can be 200mg or 300mg 
ii. For dose cohort of 500mg: starting dose can be 300mg or 400mg  
4) Dose restoration: If any subjects on reduced dose for 2 cycles or more, the subject will have 
an option for the dose modification, for example, either to remain on the same dose or 
increase one dose level up or resume initial dose. The dose modification shall be considered 
based on investigator’s clinical judgement for the best interest and care of subject and it 
must be discussed with medical monitor before implemented and document CRF timely and 
properly.    
d. The Investigator will make critical laboratory safety data available in a timely manner. 
Availability of these data will also enable the Sponsor to notify other participating study centers, as 
well as regulatory authorities, of events occurring during the trial. 
 
Assessment of safety:  
Safety will be assessed by AEs, vital signs, 12-lead ECG, pain score, and laboratory tests. 
 
Assessment of efficacy variables: 
a. 
Assessment of PSA: Blood samples will be collected to determine the serum total PSA 
concentration. 
b. 
Change of PSA from baseline: The proportion of subjects achieving a ≥50% reduction in PSA 
at 3 months (12 weeks) as compared to baseline (study entry) will be determined. 
a. Assessment of soft tissue and bone (RECIST and Prostate Cancer Working Group (PCWG)-2 
criteria): 
1) 
Soft tissue: Chest, abdomen, and pelvic CT or MRI will be performed. Changes in the 
size of target lesions will be evaluated. The timepoint overall response will be reported. 
2) 
Bone scan: Radionuclide bone scan will be performed. Number of Bone Lesion, and 
changes in the number of lesions will be reported. 
3) 
Skeletal-related events: Severity of skeletal-related event (bone pain, analgesia intake) 
will be assessed monthly per PCWG2.  
b. Performance status: ECOG performance status will be assessed. Changes from baseline will 
be evaluated 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 13 of 79 
 
Assessment of exploratory markers:  
 
Circulating tumor cells 
 
ct-DNA/ct-RNA 
 
Statistical methods: 
Analysis Populations:  
The Safety Analysis Set (SAF) will include all subjects who take at least 1 dose of study medication. 
Safety analyses will be conducted using the safety population.  
The Full Analysis Set (FAS) will include all evaluable subjects used as the supportive analysis 
population for efficacy. The FAS population will be used as the primary analysis population for 
efficacy. 
The Per Protocol (PP) Analysis Set will include all FAS subjects with the Week 12 PSA assessment 
and without major protocol violations.  
 
 
TABLE OF CONTENTS 
1 
SYNOPSIS (expanded/Phase ii) ............................................................................................. 7 
2 
LIST OF ABBREVIATIONS ............................................................................................... 17 
3 
INTRODUCTIONS .............................................................................................................. 20 
3.1 
Background on Prostate Cancer ................................................................................ 20 
3.2 
Background on GT0918 (proxalutamide) ................................................................. 21 
3.2.1 Nonclinical Studies .................................................................................................... 21 
3.2.2 Clinical Studies .......................................................................................................... 24 
3.2.3 Anticipated Clinical Risks/Benefits .......................................................................... 24 
3.3 
Rationale .................................................................................................................... 25 
4 
STUDY OBJECTIVES (exPAnded/phase II) ....................................................................... 26 
4.1 
Primary Objective ...................................................................................................... 26 
4.2 
Secondary Objectives ................................................................................................ 26 
5 
STUDY ENDPOINTS .......................................................................................................... 26 
5.1      Primary Endpoint ....................................................................................................... 26 
5.2 
Secondary Endpoints ................................................................................................. 27 
6 
INVESTIGATIONAL PLANS (exPanded/phase II) ............................................................ 27 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 14 of 79 
6.1 
Description of Overall Study Design and Plan ......................................................... 27 
6.2 
Discussion of Study Design ...................................................................................... 27 
7 
SELECTION AND WITHDRAWAL OF SUBJECTS (Expanded/Phase II)....................... 28 
7.1  
Inclusion Criteria ....................................................................................................... 28 
7.2 
Exclusion Criteria ...................................................................................................... 29 
7.3 
Withdrawal, Removal, and Replacement of Subjects ............................................... 30 
7.4 
Follow-Up for Drug Discontinuation/Subject Withdrawal from Study .................... 31 
8 
TREATMENTS .................................................................................................................... 31 
8.1 
Details of Study Medication ...................................................................................... 31 
8.2 
Dosing Schedule (expanded/phase II) ....................................................................... 32 
8.3 
Study Treatment Assignment .................................................................................... 32 
8.4 
Blinding ..................................................................................................................... 32 
8.5 
Treatment Accountability and Compliance ............................................................... 33 
8.6 
Prior and Concomitant Illnesses and Medications .................................................... 33 
8.6.1 Permitted Treatment .................................................................................................. 33 
8.6.2 Prohibited Treatment ................................................................................................. 34 
8.6.3 Dose modification and missing dose ......................................................................... 34 
9 
STUDY PROCEDURES ....................................................................................................... 35 
9.1 
Subject Informed Consent ......................................................................................... 35 
9.2 
Expanded/Phase II Study Visits ................................................................................ 35 
9.2.1 Screening Visit .......................................................................................................... 35 
9.2.2 On-Treatment Visits .................................................................................................. 36 
9.2.3 Expansion Study (Additional Cycles after Cycle 6 Day 28 (Cycle 7 Day 1, to Cycle 
23 Day 1 and Cycle 23 Day 28) ............................................................................................ 41 
9.2.4 End-of-Study (EOS) .................................................................................................. 42 
9.2.5 Unscheduled Visits .................................................................................................... 42 
10 EFFICACY ASSESSMENTS ............................................................................................... 43 
11 EXPLORATORY MARKERS ............................................................................................. 43 
12 SAFETY ASSESSMENTS ................................................................................................... 43 
12.1 
Vital Signs ................................................................................................................. 43 
12.2 
Physical Examination ................................................................................................ 44 
12.3 
Electrocardiogram ..................................................................................................... 44 
12.4 
Laboratory Assessments ............................................................................................ 45 
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12.5 
Adverse Events .......................................................................................................... 47 
12.5.1 Adverse Event Description and Reporting ................................................................ 47 
12.5.2 Serious Adverse Events ............................................................................................. 50 
12.5.3 Serious Adverse Event Reporting ............................................................................. 51 
12.5.4 Overdose .................................................................................................................... 52 
12.5.5 Pregnancy .................................................................................................................. 52 
12.5.6 Safety Review and Teleconferences .......................................................................... 52 
13 STATISTICAL ANALYSIS ................................................................................................. 53 
13.1 
Determination of Sample size ................................................................................... 53 
13.2 
Analysis Populations ................................................................................................. 53 
13.3 
Demographic and Baseline Characteristics ............................................................... 53 
13.4 
Efficacy Analysis ...................................................................................................... 55 
13.5 
Exploratory Analyses ................................................................................................ 56 
13.6 
Safety Analysis .......................................................................................................... 56 
13.7 
Interim Analysis ........................................................................................................ 56 
13.8 
Data Monitoring Committee ..................................................................................... 56 
14 STUDY MANAGEMENT .................................................................................................... 57 
14.1 
Approval and Consent ............................................................................................... 57 
14.1.1 Regulatory Guidelines ............................................................................................... 57 
14.1.2 Institutional Review Board/Independent Ethics Committee ..................................... 57 
14.1.3 Informed Consent ...................................................................................................... 57 
14.1.4 Subject Confidentiality .............................................................................................. 57 
14.2 
Data Handling ............................................................................................................ 58 
14.3 
Source Documents ..................................................................................................... 58 
14.4 
Record Retention ....................................................................................................... 58 
14.5 
Monitoring ................................................................................................................. 59 
14.6 
Quality Control and Quality Assurance .................................................................... 59 
14.7 
Protocol Amendment and Protocol Deviation ........................................................... 59 
14.7.1 Protocol Amendment ................................................................................................. 59 
14.7.2 Protocol Deviations ................................................................................................... 60 
14.8 
Ethical Considerations ............................................................................................... 60 
14.9 
Financing and Insurance ............................................................................................ 60 
14.10 Publication Policy / Disclosure of Data .................................................................... 60 
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15 REFERENCES ...................................................................................................................... 61 
16 APPENDICES ....................................................................................................................... 62 
16.1 
Schedule of Assessments 1 ........................................................................................ 62 
16.2 
APPENDIX 1:  ECOG Performance Status .............................................................. 65 
16.3 
APPENDIX 2:  RECIST Guidelines v1.1 ................................................................. 66 
16.4 
APPENDIX 3:  New York Heart Association Classifications .................................. 77 
16.5 
APPENDIX 4:  Drugs with Potential Interactions with Metabolism ........................ 78 
16.6 
APPENDIX 5:  Ingredients of GT0918 Drug Product .............................................. 79 
 
 
 
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2 LIST OF ABBREVIATIONS 
 
Abbreviation 
 
Definition 
ACTH 
adrenocorticotrophic hormone 
ADT 
androgen deprivation therapy 
AE 
adverse event 
ALT 
alanine aminotransferase  
AR 
androgen receptor 
AST 
aspartate transaminase  
AUC0-24 
area under the plasma concentration-time curve from time zero to 24 hours 
AUC0-∞ 
area under the plasma concentration-time curve from time zero to infinity 
AUC0-t 
area under the plasma concentration-time curve from time zero to the last 
sample with a quantifiable concentration 
BAP 
bone alkaline phosphatase 
C  
clearance 
Cmax 
peak plasma concentration 
CNS 
central nervous system 
CR 
complete response 
CRPC 
castration resistant prostate cancer 
CRU 
clinical research unit 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
 
ctDNA 
circulating tumor DNA 
CYPC19 
cytochrome P450 C19 
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Abbreviation 
 
Definition 
DHEA 
dehydroepiandrosterone 
DHT 
dihydrotestosterone 
DLT 
dose limiting toxicity 
DNA 
deoxyribonucleic acid 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EoS 
end of study 
ET 
early termination 
FDG-PET 
fluorodeoxyglucose positron emission tomography 
FDHT-PET 
fluorodihydrotestosterone positron emission tomography 
FSH 
follicle stimulation hormone 
GnRH 
gonadotropin releasing hormone 
ITT 
intent-to-treat 
LH 
luteinizing hormone 
LHRH 
luteinizing hormone releasing hormone 
MED 
minimal effective dose  
MedDRA 
Medical Dictionary for Regulatory Activities  
Min 
minutes 
mRNA 
messenger RNA 
MRI 
magnetic resonance imaging  
MTD 
maximum tolerated dose 
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NOAEL 
no observed adverse effect level 
NYHA 
New York Heart Association 
PCWG2 
Prostate Cancer Working Group 2 
PD 
progressive disease 
PK 
pharmacokinetics 
PP 
per protocol 
PR 
partial response 
PSA 
prostate specific antigen 
PAP 
prostatic acid phosphatase 
RECIST 
response evaluation criteria in solid tumors 
RNA 
ribonucleic acid 
RP2D 
recommended Phase II dose 
SAE 
serious adverse event 
SAS 
Statistical Analysis Software  
SD 
stable disease 
t½ 
terminal elimination half-life 
Tmax 
the time to reach the peak plasma concentration 
TSH 
thyroid stimulating hormone 
TURP 
transurethral resection of prostate 
λz 
terminal elimination rate constant 
UA 
urine analysis 
ULN 
upper limit of normal 
Vz   
volume of distribution 
WOCBP   
women of childbearing potential 
 
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3 INTRODUCTIONS 
3.1 
Background on Prostate Cancer 
Prostate cancer is the most common malignant tumor in men and is the second leading cause of 
cancer-related deaths in men, second only to lung cancer. Prostate cancer does not have 
remarkable symptoms at its early stage. Once symptoms are observed, the disease will be often 
at an advanced stage. Then the cancer progresses rapidly. If it is not treated in a timely manner, 
the average survival time will be only 3 to 5 years from the date when the symptoms are 
discovered. Metastasis is very common in subjects with prostate cancer. Approximately 1/3 to 
2/3 of subjects have lymph node metastases at their first medical visit, and hematologic 
metastases are often seen in bone. This disease depends on dihydrotestosterone (DHT) which 
activates androgen receptor (AR) signaling. Endocrine therapy (including surgery, chemotherapy 
or anti-androgen deprivation therapy or combined androgen blockade therapy) is a preferred 
treatment for prostate cancer. This treatment is very effective for the majority of subjects at the 
initial stage but after a median period of treatment of 14 to 30 months, almost all subjects will 
gradually develop castration resistant prostate cancer (CRPC) with a median survival of less than 
20 months, and urgently need a further treatment. 
As for the specific treatment for prostate cancer, surgical castration (radical prostatectomy, 
transurethral resection of prostate [TURP], and bilateral orchiectomy) and medical castration 
(luteinizing hormone releasing hormone [LHRH] antagonist and gonadotropin-releasing 
hormone [GnRH] antagonist) are the preferred means for early treatment, and they can be 
performed in combination with treatments such as endocrine, immune, differentiation, gene and 
radiation therapies. Most androgens are from the testes and a lesser amount originate from the 
adrenal glands; surgical castration can only remove the androgens originating from the testes, 
and the adrenal glands still secrete a significant amount of steroids, producing androgens and 
precursors of testosterone that enter prostatic tissues and are then released into the blood. 
Prostate cancer is highly sensitive to androgen. To achieve the purpose of treatment of prostate 
cancer, synthesis of androgen must be suppressed to prevent its interaction with AR on the cell 
surface, thereby blocking the physiological effects of androgen. The usual androgen deprivation 
therapy (ADT) is mainly focused on the hypothalamic-pituitary-testicular gonadal axis generated 
by androgen. The drug treatments are: 1) endocrine axis blocking therapy; 2) direct inhibition of 
androgen synthesis, and 3) androgen receptor inhibitor. For example, estrogen 
(Diethylstilbestrol, Transdermal estradiol and Conjugated estrogens [Premarin® tablets]) can be 
used to regulate the hypothalamic-pituitary-gonadal axis to reduce testosterone production; 
inhibitors produced by adrenal androgen (corticosteroids, ketoconazole and CYPC19 inhibitor 
abiraterone) reduce testosterone synthesis by inhibiting the relevant enzymes. Androgen receptor 
(AR) antagonists in combination with anti-androgen drugs are currently the most effective drug 
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treatment to manage the prostate cancer where castration failed. Nilutamide, flutamide, 
bicalutamide (trade name Casodex®) and enzalutamide (trade name XTANDI®) all belong to 
this class of androgen receptor antagonists. 
Enzalutamide (Xtandi) has a higher antagonistic activity than bicalutamide in CRPC cells and 
effectively suppresses the activation, preventing AR transfer from then cytoplasm to the nucleus 
and from binding to DNA, ultimately achieving significant clinical efficacy for advanced 
castration-resistant prostate cancer. Enzalutamide has shown long half-life in subjects (3-13 
days). When administered once a day, it will lead to serious drug accumulation, resulting in 
significant side effects, fatigue 34%, headache12%, and some serious neurotoxicity, such as 
induced epilepsy of 1-2 %. 
GT0918 is a new investigational second-generation androgen receptor antagonist with more 
specificity and activity in inhibiting androgen receptors; in particular, it can maintain a pure role 
of an antagonist because it does not activate the AR of CRPC cells compared to bicalutamide. As 
compared to enzalutamide, GT0918 has improvement in target potency as well as drug 
disposition properties. It is expected to reduce drug accumulation, which may reduce drug 
exposure in the CNS, therefore avoiding the CNS side effect such as seizure. 
In addition, GT0918 demonstrates a dual mechanism of action in cell assays, i.e., highly 
effective in inhibiting AR as well as exhibiting pharmacological effects of inducing the down-
regulation of AR expression; the mechanism that is not seen in bicalutamide and enzalutamide. 
Considering that over-expression of AR is one of the major mechanisms for generating 
resistance in castration therapy for prostate cancer, GT0918 could alleviate the resistance of 
castration therapy for prostate cancer because of the dual mechanism of action thus is expected 
to be a more effective and less toxic second-generation CRPC drug therapy. GT0918 may 
provide clinical benefits to some of the CRPC subjects who have developed resistance to 
enzalutamide or abiraterone treatments. 
3.2 Background on GT0918 
3.2.1 Nonclinical Studies 
Safety pharmacology, single dose and repeated dose toxicity studies, as well as genotoxicity 
study in pre-clinical in vitro and in vivo animal models suggests that GT0918 has an acceptable 
safety profile when projected for human use. The starting dose of 50 mg of GT0918 is selected 
for the treatment of subjects with metastatic castrate resistant prostate cancer (mCRPC) in the 
proposed dose ascending MTD study. 
 
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The maximum tolerated dose (MTD) was 500 mg/kg in the acute animal study, and the no 
observed adverse effect level (NOAEL) was 60 mg/kg after GT0918 orally administered to SD 
rats for 28 days. In Beagle dogs, the MTD and NOAEL were 2000 mg/kg and 50 mg/kg, 
respectively, in the acute and the 28-day study. The adverse effect noted in rat and dog studies 
were reversible during the 4-week recovery period. No seizure or convulsion was observed in 
animals throughout the general toxicology studies including high doses in acute studies as well 
as repeat dosing studies. 
In the 13-week oral gavage toxicity and toxicokinetics study in Sprague Dawley rats with a 4-
week recovery, male and female Sprague Dawley rats were given the vehicle control article or 
GT0918 at a dose level of 20, 45, or 90 mg/kg/day via oral gavage once daily for 13 weeks. No 
test article-related mortality, clinical observations, ophthalmic findings, food consumption, or 
hematology, coagulation, and urinalysis changes were noted. Low body weight was observed 
during the dosing phase in animals given ≥45 mg/kg/day, and recovered during the recovery 
phase. Minor clinical chemistry changes (e.g., increased cholesterol, phosphorus, and globulin 
and decreased albumin and chloride) were observed during the dosing phase and recovered in the 
recovery phase. Large adrenal glands (females ≥45 mg/kg/day) and small prostates (males 90 
mg/kg/day) were observed during the dosing phase and recovered in the recovery phase. 
Microscopic findings, including those in the adrenal cortex (≥20 mg/kg/day), liver (≥45 
mg/kg/day), seminal vesicles and prostate (atrophy, noted males ≥45 mg/kg/day), and mammary 
gland (males ≥20 mg/kg/day), were observed in the dosing phase. These microscopic findings 
had partially to completely resolved after the 4-week recovery phase. Since the findings were not 
severe, they were not considered as adverse. Based on these findings, the no observed adverse 
effect level (NOAEL) and the highest none-severely toxic dose (HNSTD) were 90 mg/kg/day. 
The corresponded GT0918 AUC0-t values in males and females on Day 91 were 159,000 and 
495,000 h*ng/mL, respectively. 
In the 13-week oral gavage toxicity and toxicokinetics study in Beagle dogs with a 4-week 
recovery, male and female dogs were given GT0918 at a dose level of 5, 15, and 50/30 
mg/kg/day via oral capsule once daily for up to 13-weeks, which resulted in overt toxicity at the 
dose level of 50/30 mg/kg/day. GT0918 related findings included clinical observations 
(hypoactivity, thin appearance, hunched posture, and et al.) and decreased body weight and food 
consumption in animals given >15 mg/kg/day. These findings were generally mild in animals 
given 15 mg/kg/day and showed evidence of reversibility during the recovery phase. Clinical 
chemistry and hematology changes were minor and reversible. GT0918 related increased liver 
weights and correlated hepatocellular hypertrophies were considered toxicologically significant.  
GT0918 related organ weight decreases and microscopic findings in male reproductive organs 
were consistent with the expected pharmacologic effects, and they were reversible, although the 
finding in prostate was considered adverse at 15 mg/kg/day. Due to the severe clinical 
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observations and marked decreases in body weight and food consumption in animals given 50/30 
mg/kg/day, effects at this dose were considered adverse; animals generally tolerated a dose of 30 
mg/kg/day up to 8 weeks when they were supplemented with canned dog food. Despite marked 
atrophy in the prostate of one male given 15 mg/kg/day, the no observed adverse effect level 
(NOAEL) was 15 mg/kg/day. The highest none-severely toxic dose (HNSTD) was 15 mg/kg/day 
for both males and females, which corresponds to mean Cmax and AUC values for GT0918 of 
11,600 ng/mL and 156,000 ng*hr/mL, respectively, in males and 16,300 ng/mL and 218,000 
ng*hr/mL, respectively, in females on Day 90 of the dosing phase; mean Cmax and AUC values 
for GT0955 were 5250 ng/mL and 94,200 ng*hr/mL, respectively, in males and 8320 ng/mL and 
135,000 ng*hr/mL, respectively, in females on Day 90 of the dosing phase. 
A battery of safety pharmacology studies under the U.S. GLP guidelines including behavioral 
effects in Sprague Dawley rats using the functional observational battery and a cardiovascular 
and respiratory safety pharmacology study in conscious Beagle dogs were conducted. GT0918 
inhibited hERG-mediated potassium current in CHO cells with an IC50 much higher than 10 μM. 
This strongly suggests that the potential for QT prolongation at clinically relevant concentrations 
of GT0918 is low. In addition, no evidence of QTc prolongation was observed in the 
cardiovascular and respiratory safety pharmacology study in conscious Beagle dogs after oral 
administration at doses up to 50 mg/kg. 
No significant changes in CNS function were observed with GT0918 in rats at doses up to 180 
mg/kg. GT0918 did not produce adverse effects on cardiovascular functions, respiratory 
functions and the body temperature in conscious beagle dogs after oral administration at doses up 
to 50 mg/kg.  
In addition, no evidence for activity of GT0918 was identified using in vitro Ames test, 
chromosomal aberration assay in Chinese hamster lung fibroblast with or without S9 metabolic 
activation system and in vivo micronucleus study using bone marrow in ICR mice. 
The above-mentioned 13-week subchronic toxicity studies in SD rats and Beagle dogs, safety 
pharmacology studies as well as genotoxicity studies conducted under the U.S. GLP regulations 
will support the IND opening of GT0918 in U.S. 
Altogether, these findings with high doses of GT0918 in animal were fairly benign.  When 
choosing a dose for start of clinical studies in humans, algorithms were used to choose a lower 
dose at which these findings would be absent or minimized.  Based upon the preclinical findings, 
same class drugs, the following common adverse events may be encountered during clinical trial:  
hot flush, headache, nausea, vomiting, dizziness, loss of appetite, diarrhea, and fatigue. Other 
reported adverse events from same class drugs will be monitored including not limited to back 
pain, constipation, hypertension, pain in extremities, arthralgia, and some rare cases of seizures.  
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3.2.2 Clinical Studies 
In the Phase I/II trial of GT0918 US 1001, part 1 study of dose escalation, 40 subjects have been 
treated with GT0918 at seven dose levels: daily 50 mg (n = 3), 100 mg (n = 6), 200 mg (n=6), 
300 mg (n=7), 400 mg (n=7), 500 mg (n=6), 600 mg (n=5). All subjects progressed on multiple 
lines of therapies including, but not limited to, bicalutamide, abiraterone, enzalutamide, 
docetaxel, cabazitaxel, radium 223, sipuleucel T and pembrolizumab. No DLT has been 
identified in the planned dose escalation cohorts thus MTD is not defined. GT0918 has been 
shown generally well tolerated and it has some CTCAE grade 1 and 2 AEs reported, such as 
fatigue, lethargy, nausea, loss of appetite, anemia, hypercholesterolemia, hyperglycemia, 
hyperglyceridemia, hot flush, constipation, etc. Three events of 2 grade 3 fatigue, 1 grade 3 
anemia, and one event of grade 4 elevated creatine kinase (CK) were reported. Stable disease by 
imaging scans at 20 weeks by dose group were; 1/50 mg, 1/100mg, 3/400mg, 1/500mg. PSA 
decreases were also seen among subjects with increasing dosing for a period of time. This is the 
part II study to further evaluate the safety and tolerability of 2 dosages: 400 and 500 mg in 
selected subjects with mCRPC progressed on prior treatment either abiraterone or enzalutamide. 
Early phase 1 study performed in China included 19 subjects who were treated with GT0918 in 
various doses 50 mg, 100 mg, 200 mg, 300 mg and 400 mg over 3 months.  Mild to moderated 
drug-related AEs were reported, such as hypercholesterolemia, hyperglycemia, 
hyperglyceridemia, peripheral edema, hot flash, fatigue, nausea, constipation. 
Therefore three more clinical trials (China Phase 1 Bioavailability Study, GT0918-CN-1001, 
GT0918-CN-1002) regarding to GT0918 bioavailability in healthy subject and as a monotherapy 
drug in mCRPC subjects have finished in China and five on-going GT0918 clinical trials in 
mCRPC and breast cancer subjects. More information regarding to these trials can be found in 
investigator brochure. 
3.2.3 Anticipated Clinical Risks/Benefits 
GT0918, a new investigational second generation of androgen receptor antagonist, has been 
orally administrated daily to over one hundred subjects with mCRPC or metastatic triple 
negative breast cancer (mTNBC) with androgen receptor (AR) positive. It has been shown that 
GT0918 was generally well-tolerated with some CTCAE grade 1 and 2 AEs, such as fatigue, 
lethargy, nausea, loss of appetite, anemia, hypercholesterolemia, hyperglycemia, 
hyperglyceridemia, hot flush, constipation, hepatoxicity etc. Two events of grade 3 fatigue and 
one event of grade 4 elevated creatine kinase (CK) were reported. All the participating subjects 
who had progressed disease after the prior standard and experimental therapies, including 
abiraterone and enzalutamide, showed promising clinical responses and disease control rate with 
the study drug GT0918. The ratio of risks versus benefits supports further clinical evaluations of 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
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V5.0, 18 March 2021 
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Page 25 of 79 
selected 2 doses of 400 mg and 500 mg in mCRPC and mHSPC subjects whose disease 
progressed after abiraterone or enzalutamide.  
For hepatoxicity of GT0918 monotherapy in mCRPC subjects, increased ALT and increased 
AST are the most common AEs in both China and the US. The severity is mostly grade 1-2. 
Among 2.0% (19/958) of the subjects reported grade 3 and 4 hepatoxicity AEs that believed to 
be study drug related. 9 subjects developed drug induced liver injury and 2 subjects experienced 
hepatic failure (as of 11/18/2020).    
3.3 Rationale 
Suzhou Kintor Pharmaceutical, Inc. is developing GT0918, a new investigational androgen 
receptor (AR) antagonist for the treatment of castration resistant prostate cancer (CRPC) and 
metastatic hormone sensitive cancer (mHSPC). The anticipated dosing regimen is once daily for 
oral administration. The proposed dosage form for clinical research is 100 mg per tablet. 
GT0918 is a new investigational second generation of androgen receptor antagonist with more 
specificity and activities in inhibiting androgen receptors; in particular, it can maintain a pure 
role of an antagonist because it does not activate AR of CRPC cells compared to bicalutamide. 
As compared to enzalutamide, GT0918 has improvement in target potency as well as drug 
disposition properties. It is expected to reduce drug accumulation, which may reduce drug 
exposure in the CNS, therefore avoiding the CNS side effects of enzalutamide such as seizure, 
thus improving the safety profile. 
In addition, GT0918 demonstrates a dual mechanism of action in cell assays, i.e., highly 
effective in inhibiting AR as well as other pharmacological effects such as down-regulation of 
AR expression; a mechanism that is not seen in bicalutamide or enzalutamide. Considering that 
over-expression of AR is one of the major mechanisms for generating resistance in castration 
therapy for prostate cancer, GT0918 could alleviate resistance of castration therapy for prostate 
cancer as result from the dual mechanism of action thus is expected to be a more effective and 
less toxic second-generation CRPC drug therapy. GT0918 may provide clinical benefits to some 
of the subjects who have developed resistance to enzalutamide or abiraterone treatments. These 
properties make GT0918 an ideal candidate suitable for testing in subjects with metastatic 
hormonal sensitive prostate cancer (mHSPC) or metastatic castrate resistant prostate cancer 
(mCRPC). 
In the Phase I/II study, GT0918-US-1001, part I study of dose escalation, 40 subjects have been 
treated with GT0918 at seven dose levels (detail see above 3.2.2), who progressed on multiple 
lines of therapies including abiraterone and enzalutamide. GT0918 has been generally well-
tolerated. Early phase I study performed in China included 19 subjects who were treated with 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
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GT0918 in various doses 50 mg, 100 mg, 200 mg, 300 mg and 400 mg over 3 months.  Mild to 
moderated drug-related AEs were reported, such as hypercholesterolemia, hyperglycemia, 
hyperglyceridemia, peripheral edema, hot flush, fatigue, nausea, constipation, hepatoxicity. 
Based on clinical outcomes from both phase I studies, this expanded/phase II is recommended to 
further evaluate the safety and tolerability of GT0918 at 2 dosages: 400 mg and 500 mg in 
eligible subjects with mCRPC and mHSPC.  
4 STUDY OBJECTIVES (EXPANDED/PHASE II)  
4.1 Primary Objective 
 To evaluate the safety and tolerability of GT0918 in subjects with mHSPC or 
mCRPC who failed either abiraterone or enzalutamide treatment, and to determine the 
RP2D for Ph III and/or other confirming studies 
4.2 Secondary Objectives 
 To evaluate radiographic progression-free survival (rPFS)  
 To evaluate objective response rate 
 To evaluate time to radiographic progression 
 To evaluate PSA 50% decline and maximum change at 12 weeks 
 To evaluate PSA doubling time (PSA DT) 
 To evaluate the time to PSA progression 
 
To identify exploratory biomarkers to characterize androgen receptor (AR) inhibition 
and/or down-regulation by GT0918  
5 STUDY ENDPOINTS 
5.1      Primary Endpoint 
 To select the recommended Phase II dose (RP2D) for future clinical trials and/or 
other confirmatory studies based on safety, tolerability and dose exposure  
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5.2 
Secondary Endpoints 
 To evaluate safety and tolerability of GT0918 assessed by AEs, SAEs, vital signs, 
ECG, physical exam, and laboratory safety assessments of 400 mg daily vs. 500 
mg daily over 6 months or longer treatment. 
 To evaluate proportion of subjects with a > 50% PSA suppression or increased 
PSA doubling time at 12 weeks and 24 weeks  
 CT/MRI and bone scans will be done at 12-week intervals to determine time to 
progression, and percentage of radiographic disease progression at 6 and 12 
months 
 Exploratory markers include circulating tumor cells, cell free circulating tumor 
DNA (ct-DNA)/RNA (ct-RNA), etc.  
6 INVESTIGATIONAL PLANS (EXPANDED/PHASE II) 
6.1 Description of Overall Study Design and Plan 
This expanded/Phase II, open-label, randomized, and multi-center clinical study is designed to 
evaluate the safety, tolerability and efficacy of GT0918, an orally administered AR antagonist, in 
mHSPC or mCRPC subjects who failed prior treatment of either abiraterone or enzalutamide. All 
subjects will be randomized to either take 400 mg or 500 mg for daily administration as 
recommended by the phase I clinical data. Each arm will be 30 subjects.  Subjects will have 
initial treatment up to 6 cycles with an option to continue up to additional 24 cycles as long as 
there is no progressive disease, no intolerable adverse event, no radiographic disease 
progression, no consent withdrawn by the subject or no termination of the study by the sponsor. 
6.2 
Discussion of Study Design 
GT0918 is an oral androgen receptor antagonist with superior characteristics compared to 
currently marketed AR antagonists based on both preclinical and clinical data.   
Based on clinical experience and outcomes from phase 1 (part I) dose escalation of GT0918, it is 
recommended for 400 mg or 500 mg oral administration daily for the first initial treatment up to 
6 cycles. Dose reduction is allowed for subjects (see Section 8.6.3) who experiences any study 
drug related intolerable toxicities. Study drug GT0918 is suggested to be taken on an empty 
stomach. If dosing before meal time, it is recommended to wait 1 hour before eating. If dosing 
after meals, it is recommended to wait 2 hours before taking the study drug. 
 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
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By the end of 6 cycles of initial treatment, subjects will have an end-of-6-cycles assessment to be 
determined for further treatment (Section 9.2.2.) Eligible subjects (without PD) have the option 
to be treated for additional up to 24 cycles at their assigned dose level until PD, intolerable 
toxicity or as investigator’s discretion (Section 9.2.3). At the end of 12, 18 and 24 cycles, 
assessments will be performed to determine if the subjects will move into the next 6 cycle 
treatment. 
All subjects on study drug of GT0918 are required to perform End-of-Study (EoS) assessment 
before termination (Section 9.2.4). A post-treatment safety window of 30 days is allowed for any 
possible delayed study drug-related AEs and SAEs after the last dose of study medication or end-
of-study visit which ever occur later. See schedule of assessments (Appendix 1) 
Duration of Study (expanded/phase II) 
This Phase II study is an open-label, randomized, multi-center study in mHSPC or mCRPC 
subjects who progressed on prior treatment with either abiraterone or enzalutamide.  
The study has 2 periods, a 3-week Screening Period, a up to 6 cycles Treatment Period (+ option 
of continued treatment, see above).  The study will be conducted at 10 centers in the United 
States.  
7 SELECTION AND WITHDRAWAL OF SUBJECTS (Expanded/Phase II) 
7.1  
Inclusion Criteria 
1. Signed informed consent obtained prior to any study-related procedure being performed. 
2. Subjects at least 18 years of age or older at the time of consent. 
3. Subjects with histologically confirmed mHSPC or mCRPC who received abiraterone or 
enzalutamide for the hormonal treatment of 6 months or longer.  
4. Subjects with mHSPC are required to have no prior ADT or orchiectomy. For mCRPC, 
ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone 
(LHRH) “super-agonist” or antagonist, or bilateral orchiectomy. Serum testosterone level 
is < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening. 
5. Metastatic disease documented by computed tomography (CT)/magnetic resonance 
imaging (MRI) or bone scan. 
6. Progressive disease despite hormonal treatment with abiraterone or enzalutamide, but not 
both.  However, if either of these 2 drugs was used less than 3 months before 
discontinuation due to toxicity, the subject is eligible. Progressive disease is defined by 1 
or more of the following criteria:  
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Protocol#: GT0918-US-1002 
 
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V5.0, 18 March 2021 
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a. Subjects with a rising prostate specific antigen (PSA) value > 2 ng/mL in at least 
2 measurements, at least 1 week apart. If the confirmatory PSA value is less than 
the screening PSA value, then an additional test for the rising PSA is required to 
document progression. 
b. Subjects with measurable disease, progression defined by Response Evaluation 
Criteria in Solid Tumors (RECIST) 1.1 criteria 
c. Subjects with metastatic bone disease, progression defined by 2 or more new 
lesions in a radionuclide bone scan. 
7. ECOG performance status of 0-1  
8. Screening blood counts of the following: 
a. Absolute neutrophil count ≥ 1500/μL 
b. Platelets ≥ 100,000/μL 
c. Hemoglobin > 9 g/dL (if asymptomatic). 
9. Screening chemistry values of the following: 
a. Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper 
limit of the normal reference range (ULN) 
b. Total bilirubin ≤ 2 × ULN 
c. Creatinine ≤ 1.5 × ULN 
d. Albumin > 2.8 g/dL.  
10. At screening, life expectancy of at least 6 months. 
11. Subjects whose partners are women of childbearing potential (WOCBP) must use an 
adequate method of birth control while on study drug and for at least 3 months after 
discontinuation of study drug. 
12. Subject is willing and able to comply with all protocol required visits and assessments  
 
7.2 
Exclusion Criteria 
1. Discontinuation of enzalutamide or abiraterone less than 3 weeks prior to the start of 
study medication.  
2. Prior chemotherapy and experimental therapy (PARP or checkpoint inhibitor). 
3. Ongoing acute treatment-related toxicity associated with a previous therapy greater than 
grade 1 except for grade 2 alopecia or neuropathy. 
4. History of impaired adrenal gland function (e.g., Addison’s disease, Cushing’s 
syndrome). 
5. Known gastrointestinal disease or condition that affects the absorption of GT0918. 
6. History of congestive heart failure New York Heart Association (NYHA) class III or IV 
or uncontrolled hypertension at screening. 
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Protocol#: GT0918-US-1002 
 
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V5.0, 18 March 2021 
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7. History or family history of long QT syndrome, or ECG corrected QT interval equal to and 
over 500 ms (CTCAE grade 2) at baseline. 
8. History of other malignancy within the previous 3 years, except basal cell or squamous 
cell carcinoma, or non-muscle invasive bladder cancer. 
9. Use of systemic glucocorticoid (e.g., prednisone, dexamethasone) within 14 days prior to 
the start of study medication. Inhaled or topical steroids are allowed. 
10. Co-administration of CYP3A4 ligands that serve as substrates or induce or inhibit the 
enzyme. (See Appendix 4 of list of medications) If such medication needs to be used for 
the chronic illness, the medication shall be changed to another one that is not on the list 
or the dose should be reduced, at the discretion of the Investigator. 
11. Prior use of any herbal products known to decrease PSA levels (e.g., PC-SPES or saw 
palmetto) within 30 days prior to the start of study medication. 
12. Major surgery within 30 days prior to the start of study medication. 
13. Blood transfusion (including blood products) within 1 week of screening. 
14. Serious persistent infection within 14 days prior to the start of study medication. 
15. Serious concurrent medical condition including CNS disorders. 
16. Previous history of difficulty swallowing capsules. 
17. Known hypersensitivity to GT0918 or its excipients (See Appendix 5 for drug details).  
18. Any condition that, in the opinion of the investigator, would impair the subject’s ability 
to comply with study procedures 
 
7.3 
Withdrawal, Removal, and Replacement of Subjects 
A subject may voluntarily withdraw or be withdrawn from the study at any time for reasons 
including, but not limited to, the following reasons. All sites are required to inform project team, 
Medical Monitor or/and sponsor and discuss possible alternatives in order to keep high quality of 
study data. No replacement of subjects in Phase II study. 
1) Progressive disease 
2) Unacceptable toxicity or AE 
3) Subject withdrawal of consent:  At any time, a subject's participation in the study may 
terminate at his request or on the basis of the Investigator’s clinical judgment.  The reason for 
subject withdrawal will be noted on the case report form (eCRF). 
4) Intercurrent illness:  a condition, injury, or disease unrelated to the primary diagnosis that 
became apparent during treatment and necessitated the subject's termination from the study. 
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Protocol#: GT0918-US-1002 
 
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V5.0, 18 March 2021 
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5) General or specific changes in the subject's condition that renders him ineligible for further 
treatment according to the inclusion/exclusion criteria. 
6) Protocol deviation:  The subject’s findings or conduct failed to meet the protocol entry 
criteria or the subject failed to adhere to the protocol requirements (e.g., drug noncompliance, 
failure to return for defined number of visits).  The deviation necessitated premature 
termination from the study. 
7) Lost to follow-up:  The subject stopped coming for visits, and study personnel were unable to 
contact the subject after at least 3 documented attempts (including certified letter) to contact 
the subject. 
8) This study may be terminated at the discretion of the Sponsor or any regulatory agency.  An 
Investigator may elect to discontinue or stop the study at his or her site for any reason 
including safety or low enrollment. 
9) There is no subject replacement in this phase II study. 
 
7.4 
Follow-Up for Drug Discontinuation/Subject Withdrawal from Study 
If a subject discontinues study treatment and is withdrawn from the study for any reason, the 
study site must immediately notify the project team and sponsor and discuss possible alternatives 
in order to keep high quality of study data.  The date and the reason for study discontinuation 
must be recorded on the eCRF.  In the event where a subject discontinues prematurely from the 
study due to a study drug-related AE or SAE, the AE or SAE will be followed until it is resolved 
(returns to normal or baseline values) or stabilizes. Office visits are recommended for these 
subjects until it is judged by the investigator to be no longer necessitated. 
Once a subject is withdrawn from the study, the subject may not re-enter the study. 
8 TREATMENTS 
8.1 
Details of Study Medication 
GT0918 is an androgen receptor antagonist (MW 517.5 g/mol).  The dosage form for clinical 
research is a 100 mg tablet weighing 320 mg per tablet. The 100 mg tablet is circular in shape 
with 10 mm in diameter. The color is light pinky with PRO print on pills. The drug product 
tablets are packaged in PTP aluminum and PVC blister foils. These packaging materials are in 
compliance with 21CFR 174-186 – Indirect Food Additive Regulations.  
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
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The recommended storage conditions for GT0918 tablets are room temperature, with a shelf-life 
of 2 years. All drug supplies will be provided by the Sponsor.  
 
8.2 
Dosing Schedule (expanded/phase II) 
In expanded/Phase II, all subjects will be randomized into 2 groups to take either 400 or 500mg 
oral GT0918 once a day for 28 days each cycle for initial treatment of 6 cycles. At the end of 
6/12/18/24 cycles of GT0918 treatment, subjects without progressive disease (PD) may continue 
study drug GT0918 treatment with the approval of the investigator, medical monitor and 
sponsor; treatment can continue until a subject experience an intolerable adverse event (AE) or 
experiences disease progression, withdraws consent or until termination of the study by the 
sponsor. All subject’s disease condition will be re-evaluated every 3 cycles (84 days + 7) in order 
to qualify for additional treatment. If any subject shows mix response (for example, only PSA 
raising or mix response on imaging scan, or lesion increasing in size without PSA raising, or no 
clinical progression), treatment can be continued for additional 4-6 weeks and then another PSA 
or tumor assessment can be scheduled to confirm if disease progression is determined. In case 
PD is confirmed that will conclude with an end-of-study visit.  
All subjects will have safety review at the end of every cycle conducted by participating 
principal investigators (PIs) and medical monitor. In addition, the medical monitor can prompt a 
safety review at any time. 
Toxicity reported during the study will be graded according to the CTCAE (Common 
Terminology Criteria for Adverse Events) v4.03. Laboratory Assessments will include blood 
chemistry, hematology, ECGs, and urinalysis. 
 
8.3 
Study Treatment Assignment 
Subjects will be randomized between the 2 treatment arms. 
 
8.4 
Blinding 
NOT APPLICABLE 
 
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Protocol#: GT0918-US-1002 
 
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8.5 
Treatment Accountability and Compliance 
The investigation site will maintain records of study drug (investigational product) delivered to 
the study site; the inventory at the site; the distribution to and use by each subject; and the return 
of study drug to the Sponsor for storage and/or disposal.  These records should include dates, 
quantities, batch/blister card/pouch/serial numbers, expiration dates, in-clinic temperature log(s), 
and unique code numbers assigned to the study drug and study subjects.   
At each visit after initiation of treatment, site staff will record compliance of subjects with their 
assigned regimen.  Subjects will be instructed to bring their study drug pouches containing 
unused/partially used/empty blister cards back for inspection at each study visit.  Subjects are to 
be reminded of the importance of compliance with their assigned regimen, with an emphasis on 
taking their study drug on schedule and maintaining the prescribed interval between doses. 
Investigators will maintain records that document adequately that the subjects were provided 
with the correct study drug kits and will reconcile the products received from the drug dispensing 
center.  Study drug will not be returned to the Sponsor or destroyed at the clinical site until 
accountability has been fully determined. 
Medication containers must be returned at each visit, as compliance will be assessed by tablet 
counts.  Noncompliance is defined as taking less than 80% or more than 120% of study drug 
during any outpatient evaluation period (visit to visit). Discontinuation for noncompliance is at 
the investigator’s discretion and is to be noted on the eCRF.  
8.6 
Prior and Concomitant Illnesses and Medications 
Investigators should document all prior significant illnesses that the subject has experienced 
within 5 years prior to screening.  Medical histories with ongoing or worsening condition before 
5 years prior to screening may be documented per investigator’s discretion.  Additional illnesses 
present at the time when informed consent is given and up to the time of first dosing are to be 
regarded as concomitant illnesses.  Illnesses first occurring or detected during the study and/or 
worsening of a concomitant illness during the study are to be documented as AEs on the eCRF.   
8.6.1 Permitted Treatment 
 Full supportive care is to be administered per normal or routine practice at the study 
center.  Concomitant anti-cancer therapy is not permitted.  Palliative and supportive care 
for disease-related symptoms will be allowed to subjects in this study (e.g. 
bisphosphonates).  However, subjects requiring palliative radiation anti-cancer therapy 
will be removed from the study.   
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
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Confidential 
 
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 Subjects are required to continue the LHRH super-agonists/antagonists (if currently 
receiving this therapy prior to Cycle 1, Day 1) therapy unless having undergone bilateral 
orchiectomy. 
 Standard therapies for concurrent medical conditions, such as if the subject is taking a 
regimen for pain control under physician supervision. 
 Treatment for nausea, vomiting, and diarrhea, should they occur is allowed, using 
standard agents per institute’s standard of practice. Tylenol and over the counter NSAIDs 
are also allowed. 
 Subjects may receive antibiotics for infections that might occur 
8.6.2 Prohibited Treatment 
 Glucocorticoids and herbs known to alter PSA levels (saw palmetto or PC-SPES)    
 Any concurrent chemotherapy, radiotherapy, hormonal therapy (AR antagonists.), or 
immunotherapy 
 Inducers or inhibitors of CYP3A4, or sensitive CYP3A substrates (detail see appendix 4)  
 Other investigational agents  
8.6.3 Dose modification and missing dose 
Treatment modifications will be made based on specified safety criteria. Subjects may skip or 
discontinue treatment with GT0918 if they experience at least one adverse event, (noted below), 
following their dose of GT0918, and are considered by the Investigator to be “possibly”, 
“probably” or “definitely” related to study drug. Treatment modifications must be reported to 
the project team and discussed with the assigned medical monitor. 
1) For any subjects experiencing grade 3 or 4 hematologic and/or biochemical toxicity, 
study drug will be temporarily interrupted until toxicity resolves to grade 1 or better 
2) For any subjects experiencing grade 2 non-hematologic toxicity with significant 
impact on subject’s daily active life, such as asthenic condition (including asthenia 
and fatigue), hepatoxicity, mental impairment and anxiety, study drug will be 
temporarily interrupted until toxicity resolves to grade 1 or better 
3) If the Investigator considers that continuing study drug is clinically beneficial for the 
subjects, the treatment and dose can be resumed. For some subjects if dose reduction 
is safe and clinically appropriate, a dose range of 25-50% dose reduction from 
original starting dose can be considered. The dose modification and schedule must be 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
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discussed prior to implementation with the assigned medical monitor. Possible dose 
reductions are proposed as follow. 
i. For dose cohort of 400mg: starting dose can be 200mg or 300mg 
ii. For dose cohort of 500mg: starting dose can be 300mg or 400mg  
 
Dose restoration: If any subjects on reduced dose for 2 cycles or more, the subject will have an 
option for the dose modification, for example, either to remain on the same dose or increase one 
dose level up or resume initial dose. The dose modification shall be considered based on 
investigator’s clinical judgement for the best interest and care of subject and it must be discussed 
with medical monitor before implemented and document CRF timely and properly.    
The subject may discontinue study drug for up to 5 consecutive days without being discontinued 
for noncompliance, which is at the investigator’s discretion and is to be noted on the eCRF. 
Study drug GT0918 is administrated orally once per day on empty stomach at least one hour 
before or 2 hours after a meal. Subjects are recommended to take GT0918 on the same time of 
the day during entire treatment. In case there is accidentally a missing dose of study drug on 
usual dosing time, the subject may take the drug as soon as possible within 8 hours. If the drug 
cannot be taken within 8 hours of the scheduled dosing time, the subject should omit the dosing 
on that day and report missing dose in CRF. However, a subject is not allowed to have “missing 
doses” in consecutive days unless he has intolerable toxicities and is requested by investigator 
for study drug interruption.  
9 STUDY PROCEDURES 
The Schedule of Assessments (Appendix 1) outlines the timing of procedures, and assessments 
to be performed throughout the study.  
9.1 
Subject Informed Consent 
Prior to performing any study-related procedures, the Investigator (or his/her designated staff 
member) will obtain signed written informed consent from the subject.  
9.2 
Expanded/Phase II Study Visits 
9.2.1 Screening Visit 
Screening Visit (days -21 to -1) will occur within 3 weeks prior to Day 1. Re-screening is 
allowed for some special cases where clinical reassessments are required and approved by 
medical monitor. Assessments performed as part of standard of care and obtained prior to 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
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informed consent but within 28-days of enrollment may be used in some cases to satisfy the 
screening criteria. The following assessments and tests will be performed:  
 Informed consent 
 Inclusion/Exclusion Criteria 
 Demographics, Medical and Surgical History 
 Schedule CT or MRI, or/and bone scan preferably within -7 days of Day 1 of treatment 
OR 
Document/Assess Disease Status (Obtain CT or MRI or/and bone scan that may be 
performed as part of standard care within 6 weeks prior to Day 1 to confirm screening 
requirements) 
 Vital Signs, including Height and Body Surface Area (BSA) (Screening only) 
 Complete Physical Exam  
 ECOG performance status 
 Laboratory Tests (fasting where applicable):  hematology, PT/PTT/INR, chemistry 
including electrolytes, urinalysis, lipid profile and blood glucose, PSA, LDH, and 
testosterone 
 12 lead ECG 
 Assess Prior/Concomitant medication usage. If pain medications are taken, list name, 
dosage, frequency, etc. 
9.2.2 On-Treatment Visits 
 
Cycle 1, Day 1 (Week 1) before dosing for ALL subjects 
 Admit to Clinical Research Unit (CRU) 
 Confirm screening eligibility test results are acceptable for study participation 
 Review and record Interim Medical and Surgical History (prior to first dose) 
 Vital signs (prior to first dose) 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
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 Abbreviated Physical Exam  
 ECOG (prior to first dose) 
 Laboratory Tests (fasting where applicable): hematology, chemistry & electrolytes, 
urinalysis, lipid profile and blood glucose, PSA, and LDH  
 12 lead ECG  
 Assess AEs  
 Assess Concomitant Medication usage/confirmation. If pain medications are taken, list 
name, dosage, frequency, etc. 
 Study drug disposition 
 Exploratory markers: circulating tumor cells (CTC), ct-DNA and ct-RNA 
Cycle 1 Day 15 
 Subject returns to CRU 
 Vital Signs  
 Abbreviated Physical exam 
 ECOG 
 Assess for AEs 
 Assess compliance by pill count 
 Assess concomitant meds usage/confirmation. If pain medications are taken, list name, 
dosage, frequency, etc. 
 Study drug disposition 
Cycle 2 Day 1 (Study day 29) 
 Subject returns to CRU  
 Vital signs  
 Abbreviated Physical Exam 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
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 ECOG performance status 
 Laboratory Tests: hematology, chemistry & electrolytes, lipid profile and glucose, PSA, 
LDH, testosterone, and urinalysis 
 12-lead ECG  
 Assess AEs 
 Assess Concomitant Medication usage/confirmation. If pain medications are taken, list 
name, dosage, frequency, etc.  
 Assess compliance by pill count 
 Study drug disposition 
Cycle 3 Day 1 (Study day 57) 
 Subject returns to CRU  
 Vital signs  
 Abbreviated Physical Exam 
 ECOG performance status 
 Laboratory Tests: hematology, chemistry & electrolytes, lipid profile and glucose, PSA, 
LDH, testosterone, and urinalysis 
 Assess AEs 
 Assess Concomitant Medication usage/confirmation. If pain medications are taken, list 
name, dosage, frequency, etc.  
 Assess compliance by pill count 
 Study drug disposition 
Cycle 4 Day 1 Study day 85 
 Subject returns to office/CRU  
 Vital signs  
 Complete Physical Exam 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
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 ECOG performance status 
 Laboratory Tests: hematology, chemistry & electrolytes, lipid profile and glucose, PSA, 
PT/PTT/INR, LDH, testosterone, urinalysis  
 Assessment of exploratory markers: circulating tumor cells (CTC), ct-DNA and ct-RNA, 
and androgen receptor (AR) related gene profiles  
 12-lead ECG  
 CT/MRI, Bone Scan 
 Assess AEs 
 Assess Concomitant Medication usage/confirmation. If pain medications are taken, list 
name, dosage, frequency, etc.  
 Assess compliance by pill count 
 Study drug disposition 
 Exploratory Markers 
Cycle 5 Day 1 Study day 113 
 Subject returns to office/CRU  
 Vital signs  
 Abbreviated Physical Exam 
 ECOG performance status 
 Laboratory Tests: hematology, chemistry & electrolytes, lipid profile and glucose, PSA, 
LDH, testosterone, and urinalysis 
 Assess AEs 
 Assess Concomitant Medication usage/confirmation. If pain medications are taken, list 
name, dosage, frequency, etc.  
 Assess compliance by pill count 
 Study Drug disposition 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
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V5.0, 18 March 2021 
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Cycle 6 Day 1 Study day 141  
 Subject returns to office/CRU  
 Vital signs  
 Abbreviated Physical Exam 
 ECOG performance status 
 Laboratory Tests: hematology, chemistry & electrolytes, lipid profile and glucose, PSA, 
LDH, testosterone, and urinalysis 
 Assess AEs 
 Assess Concomitant Medication usage/confirmation. If pain medications are taken, list 
name, dosage, frequency, etc.  
 Assess compliance by pill count 
 Study drug disposition 
Study day 169 (if eligible for continuous treatment, this will be Cycle 7 Day 1)  
 Subject returns to CRU  
 Disease Assessment scans (CT or MRI or bone scan). 
 Vital signs  
 Complete Physical Exam 
 ECOG performance status 
 Laboratory Tests: hematology, chemistry & electrolytes, lipid profile and glucose, PSA, 
PT/PTT/INR, LDH, testosterone, urinalysis,  
 12-lead ECG 
 Exploratory markers: circulating tumor cells (CTC), ct-DNA and ct-RNA 
 Assess AEs 
 Assess Concomitant Medication usage/confirmation. If pain medications are taken, list 
name, dosage, frequency, etc.  
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
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 Assess compliance by pill count 
 Study drug disposition (if on Cycle 7 Day 1) 
 
9.2.3 Expansion Study (Additional Cycles after Cycle 6 Day 28 (Cycle 7 Day 1, to 
Cycle 30 Day 28) 
Eligible subjects (no disease progression) have the option to continue additional cycles (up to 18 
more cycles) on their assigned dose level until they exhibit PD and/or investigator discretion. 
Visits will occur every cycle/month, i.e. every 28 days (+/- 3 days). Every 3 cycles, the subjects 
will be given a disease assessment scan (CT and/or MRI or bone scan). Every 6 cycles, the 
subjects will be assessed by Investigator and discussed with Medical Monitor or/and Sponsor to 
determine whether to proceed into the next 6 cycles. 
 Subject returns to office 
 Disease Assessment scans (CT or MRI or bone scan) are to be performed every 3 cycles 
(84 +/- 14 days, Cycle 7 Day 1, Cycle 10 Day 1, Cycle 13 Day 1, Cycle 16 Day 1, Cycle 
19 Day 1, Cycle 22 Day 1, Cycle 24 Day 28, Cycle 27 D28 and Cycle 30 D28). 
 Vital signs  
 Complete Physical Exam (Every 3 cycles on Cycle 7 Day 1, Cycle 10 Day 1 Cycle 13 
Day 1, Cycle 16 Day 1, Cycle 19 Day 1, Cycle 22 Day 1, Cycle 24 Day 28, Cycle 27 D28 
and Cycle 30 D28)  
 Abbreviated Physical Exam (Cycle 8 Day 1, Cycle 9 Day 1, Cycle 11 Day 1, Cycle 12 
Day 1, Cycle 14 Day 1, Cycle 15 Day 1, Cycle 17 Day 1, Cycle 18 Day 1, Cycle 20 Day 
1, Cycle 21 Day 1, Cycle 23 Day 1, Cycle 24 Day 1, Cycle 26 Day 1, Cycle 27 Day1, 
Cycle 29 Day 1, Cycle 30 Day 1) 
 ECOG status 
 Laboratory Tests: hematology, chemistry & electrolytes, testosterone, PSA, and 
urinalysis, lipid profile/blood glucose performed every 3 months (For subjects with 
abnormal lipid profiles monthly testing is required.)  
 12-lead ECG (every 3 cycles on Cycle 7 Day 1, Cycle 10 Day 1 Cycle 13 Day 1, Cycle 
16 Day 1, Cycle 19 Day 1, Cycle 22 Day 1, Cycle 25 Day 1 and Cycle 28 Day 1 ) 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 42 of 79 
 Exploratory markers (every 3 cycles on Cycle 7 Day 1, Cycle 10 Day 1, Cycle 13 Day 1, 
Cycle 16 Day 1, Cycle 19 Day 1, Cycle 22 Day 1, Cycle 25 Day 1 and Cycle 28 Day 1) 
 Administer study drug from subject supply in the office  
 Study drug disposition (unless this is the last visit of the extension study) 
 Assess AEs 
 Assess Concomitant medication usage/confirmation. If pain medications are taken, list 
name, dosage, frequency, etc. 
 Assess compliance by pill count 
9.2.4 End-of-Study (EOS)  
All subject will have End-of-study visit before discontinued. If the EoS is equal to or less than 14 
days from previous scheduled visit, the EoS visit can be omitted and the assessment will be the 
previous visit.  
 Subject (if qualified) returns to office/CRU 
 Vital signs  
 Abbreviated Physical Exam 
 ECOG status 
 Laboratory Tests: hematology, chemistry & electrolytes, and urinalysis 
 Assess AEs 
 Assess Concomitant medication usage/confirmation  
 Assess compliance by pill count 
 Exploratory markers 
 
9.2.5 Unscheduled Visits 
The Investigator may at his/her discretion arrange for a subject to have an unscheduled 
assessment, especially in the case of adverse events (AEs) that require follow-up or an AE 
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considered by the Investigator to be possibly related to the use of study drug.  The unscheduled 
visit page in the eCRF must be completed. 
9.2.6 30-day safety follow-up “window”  
GT0918 is a new 2nd generation of androgen receptor antagonist. The phase I data shows that the 
average elimination half-life between 400 mg and 500 mg is approximately 7 days (189 to 267 
hours). Thus the safety follow-up “window” is set for 30 days after last dose of study drug 
GT0918 for any possible drug-related AE or SAE. Drug-related AE should be followed up until 
complete resolution or equal to the level of baseline. The safety follow-up visit can also be done 
over the phone or in the office if there is SAE and clinically indicated. If subject starts with 
different treatment or therapy, the window of safety follow-up will be closed. Any AE and/or 
SAE unrelated to the study drug is not required to report. 
 Safety assessment on the AEs. 
10 EFFICACY ASSESSMENTS 
Efficacy measures, timing, and required tests are detailed in Section 14 (“Statistical Analysis”). 
11 EXPLORATORY MARKERS 
 CTCs, ct-DNA and ct-RNA  
12 SAFETY ASSESSMENTS 
Safety assessments (vital signs, physical examinations, electrocardiogram (ECG) recording, AEs, 
clinical laboratory results (routine hematology and chemistry) are to be performed at protocol-
specified visits, as specified in the Schedule of Assessments. 
12.1 Vital Signs 
Vital signs (body temperature, respiration rate, heart rate, systolic and diastolic blood pressure 
measurements) will be evaluated at the visits indicated in the Schedule of Assessments.  All vital 
signs will be measured after the subject has been resting in a sitting position for at least 5 
minutes.  Blood pressure measurements are to be taken in the same non-dominate arm for the 
duration of the study.  Body weight (without shoes) will be recorded whenever vital signs are 
recorded. Height (without shoes) and BSA will be recorded at screening only. 
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Protocol#: GT0918-US-1002 
 
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Vital sign measurements will be repeated manually if clinically significant or 
machine/equipment errors occur.  Out-of-range blood pressure, respiratory rate or heart rate 
measurements will be repeated at the Investigator’s discretion.  Any confirmed, clinically 
significant vital sign measurements must be recorded as AEs. 
12.2 Physical Examination 
Complete physical examinations (general appearance, skin, HEENT including thyroid, heart, 
lungs, abdomen, cervical and axillary lymph nodes, extremities, neurological, and 
musculoskeletal systems) will be performed at Screening (Day -21 to Day -1) and at continued 
treatment Cycles 2-24. In addition, medical history will be recorded at screening and prior to first 
dose at Cycle 1, Day 1; including smoking history, if applicable. 30 days after last dose, a 
physical exam will be performed. 
An abbreviated physical examination to verify continued subject eligibility and to follow up any 
change in medical history will be performed at the visits indicated in the Schedule of 
Assessments.  Symptom-driven limited physical examinations will be performed as clinically 
indicated at any study visit.  All changes not present at baseline or described in the past medical 
history and identified as clinically noteworthy must be recorded as AEs. 
12.3 Electrocardiogram 
A 12-lead resting ECG will be obtained at the visits indicated in the Schedule of Assessments. 
ECGs will be performed during Screening. At Screening, the Investigator will examine the ECG 
traces for signs of cardiac disease that could exclude the subject from the study. Additional 
ECGs will be done on Cycle 1 Day 1, Cycle 1 Day 29, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 10 
Day 1 Cycle 13 Day 1, Cycle 16 Day 1, Cycle 19 Day 1, Cycle 22 Day 1, Cycle 24 Day 28 and 
at the end of the study (or earlier if clinically indicated).  An assessment of normal or abnormal 
will be recorded. If the ECG is considered abnormal, the abnormality will be documented on the 
eCRF.  ECGs will be repeated if clinically significant abnormalities are observed or artifacts are 
present. ECGs will be archived for further evaluation as necessary. If technical issues impede the 
interpretation, all available ECGs at each time point will be used to interpret the result.   
ECGs, including the heart rate, PR, QRS, and the QTc intervals will be calculated automatically 
by the ECG equipment and will be assessed by the investigator or their designee. The designated 
physician will review the ECGs to detect a prolongation of the QTc compared to the Baseline 
tracing.  QTc intervals automatically determined by the ECG equipment will be acceptable for 
detection of prolongation, provided that it is confirmed by a qualified physician later.  The mean 
of the QTc intervals collected at each time point will be compared to the Baseline tracing.  For 
individual subjects, prolongation of the QTc will be defined as (a) an increase in the QTc to > 
500 ms for a subject without pre-existing bundle-branch block; (b) an increase in the QTc to > 
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Protocol#: GT0918-US-1002 
 
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Confidential 
 
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550 ms for a subject with a pre-existing bundle-branch block; or (c) an increase in the QTc by > 
60 ms at any single time point or by >30 ms at 2 successive time points.  In any case of QT 
prolongation detected by the investigative site, the tracing will be promptly forwarded to the 
medical monitor for confirmation.  
If QT interval prolongation is confirmed, the next dose of study medication will be held until 
normalization of the QT interval has been observed by 2 sets of triplicate ECGs taken with a 
minimum of 1 hour apart.  A grade 3 QTc interval prolongation (QTc >500 ms on 2 consecutive 
ECGs) will be considered a DLT and reported to sponsor immediately.  In the case of any 
dysrhythmias that are believed by the investigator to be drug-induced, they will be treated with 
appropriate measures such as magnesium administration, anti-arrhythmics, temporary pacing, 
etc., until the arrhythmia resolves. 
12.4 Laboratory Assessments 
Laboratory assessment samples are to be obtained at designated visits as detailed in the Schedule 
of Assessments. 
Table 1: 
Laboratory Assessments 
Hematology 
Serum chemistry 
Urine analysis 
(dipstick) 
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V5.0, 18 March 2021 
Confidential 
 
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Full and differential blood count
Hematocrit (Hct) 
Hemoglobin (Hgb) 
Mean corpuscular hemoglobin 
 
(MCH) 
Mean corpuscular hemoglobin 
 
concentration (MCHC) 
Mean corpuscular volume 
(MCV) 
Platelet count 
Red blood cell (RBC) count  
White blood cell (WBC) count 
 
with differential  
 
Albumin 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Alkaline phosphatase (ALP) 
Blood Urea Nitrogen (BUN) or 
Urea 
Carbon dioxide (CO2) 
Creatinine 
Electrolytes (Na, K, Cl, Ca, P) 
Glucose  
Lactate dehydrogenase (LDH)  
Total bilirubin 
Direct bilirubin 
Total cholesterol 
Triglycerides 
Testosterone every 28 days 
PSA every 28 days 
Appearance 
pH 
Protein 
Glucose 
Ketone bodies 
Indicators of blood 
and WBCs 
Specific gravity 
Urobilinogen 
Coagulation 
 
 
PT/PTT/INR  
 
 
 
Blood samples will be analyzed at a local laboratory facility.  Urine samples will be analyzed by 
dipstick, and a microscopic analysis will be performed if the results of dipstick indicate 
abnormalities to be further investigated by a local laboratory.  All laboratory reports must be 
reviewed, signed, and dated by the Investigator.  A legible copy of all reports must be filed with 
both the subject's source documents and medical record (source document) for that visit.  Any 
laboratory test result considered by the Investigator to be clinically significant should be 
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considered an AE (clinically significant AEs include those that require an intervention).  
Clinically significant abnormal values occurring during the study will be followed until repeat 
test results return to normal, stabilize, or are no longer clinically significant.  
12.5 Adverse Events 
12.5.1 Adverse Event Description and Reporting 
An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges 
or, if present at screening, worsens during the study, regardless of the suspected cause of the 
event.  All medical and psychiatric conditions (except those related to the indication under study) 
present at screening and up until the first dose of study medication will be documented in the 
medical history eCRF.  Worsening of these conditions and newly emerged symptoms, physical 
signs, syndromes, or diseases should be noted on the AE eCRF during the study.   
Progressed disease (PD) and death caused by PD are not AE/SAE and should not be reported on 
the AE page of the eCRF.  
Laboratory test results will be recorded on the laboratory results pages of the eCRF.  Laboratory  
test value abnormalities, if not clinically significant, should not be reported on the AE page of 
the eCRF as AEs.  Clinically significant laboratory abnormalities should be recorded as AEs.  
Conditions that result from a pre-planned surgical procedure arranged before the subject 
enrollment, are not considered AE or SAEs if the expected conditions were known before study 
inclusion. Such medical condition should be reported in the subject’s medical history. 
Additionally, anticipated AEs for this study population, listed below, must be reported by 
Investigators to the Medical Monitor but will not be expedited on an individual basis.  Instead 
these AEs will be reviewed in aggregate every 3 months by the Sponsor.  This aggregate review 
may result in an expedited safety report. 
List of Anticipated AEs for this Study 
diarrhea 
loss of appetite 
pain in extremities 
dizziness 
nausea 
Arthralgia/myalgia 
fatigue/lethargy 
vomiting 
back pain 
headache 
constipation 
hot flush 
hypercholesterolemia 
hyperglycemia 
hyperglyceridemia 
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peripheral edema 
anemia 
fever/chills/flu-like 
symptoms 
blurred vision 
dry eyes 
taste changes/sensitivity to 
salt 
gastro-esophageal reflux 
increased CK levels 
onychoschizia 
Spinal cord compression 
Elevated transaminase 
Liver injury 
Hepatic failure 
Hepatic cirrhosis 
 
 
List of adverse events (potential AR antagonist class effects and AEs reported from 
enzalutamide and abiraterone in clinical trials): 
Enzalutamide: seizures, posterior reversible encephalopathy syndrome (PRES), 
hypersensitivity, embryo-fetal toxicity, hypertension 
Abiraterone: hypertension, hypokalemia, fluid retention (from increased mineralocorticoid 
levels), hepatotoxicity (post-marketing experience) 
Subjects will be asked about and instructed to report AEs at each study visit.  All drug-related 
AEs are to be followed until resolution or until a stable clinical endpoint is reached. 
All AEs are to be documented on the eCRF with reference to date of onset, duration, frequency, 
severity, relationship to study drug, action taken with study drug, treatment of event (if any), and 
outcome.  Furthermore, each AE is to be classified as being serious or non-serious.  Changes in 
AEs and resolution dates are to be documented on the eCRF. 
The purposes of this phase II trial is to study safety and tolerability of GT0918, the period of 
collection of AEs is from the time of first dose to the last dose of study drug or EoS visit. The 
30-day safety follow up “window” is set to capture possibly drug-related AE and/or SAE. 
Regardless if subject has discontinued from study drug, any drug-related AE or SAE is required 
to follow until the event is resolved or stabilized at a level of baseline.  
When subject starts with new therapy, the safety window of AE collection is closed 
simultaneously. All drug-unrelated or irrelevant AEs/SAEs such as disease progression and/or 
from new treatment should NOT be reported. 
 Specific guidelines for classifying AEs by intensity and relationship to study drug are given in 
Table 2 and Table 3. 
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Table 2: 
Classification of Adverse Events by Intensity 
Grade 1: MILD: An event that is easily tolerated by the subject, causing minimal 
discomfort and not interfering with everyday activities. 
Grade 2: MODERATE: An event that is sufficiently discomforting to interfere with normal 
everyday activities. 
Grade 3: SEVERE: An event that prevents normal everyday activities. 
Grade 4: LIFE THREATENING: An event that requires urgent intervention. 
Grade 5: DEATH: An event that is related to death. 
 
Table 3: 
Classification of Adverse Events by Relationship to Study Drug 
UNRELATED: This category applies to those AEs that are clearly and incontrovertibly due 
to extraneous causes (disease, environment, etc.). 
UNLIKELY:  This category applies to those AEs that are judged to be unrelated to the test 
drug, but for which no extraneous cause may be found.  An AE may be considered unlikely 
to be related to study drug if or when it meets 2 of the following criteria:  (1) it does not 
follow a reasonable temporal sequence from administration of the test drug; (2) it could 
readily have been produced by the subject’s clinical state, environmental or toxic factors, or 
other modes of therapy administered to the subject; (3) it does not follow a known pattern of 
response to the test drug; or (4) it does not reappear or worsen when the drug is re-
administered. 
POSSIBLY: This category applies to those AEs for which a connection with the test drug 
administration appears unlikely but cannot be ruled out with certainty.  An AE may be 
considered possibly related if or when it meets 2 of the following criteria: (1) it follows a 
reasonable temporal sequence from administration of the drug; (2) it could not readily have 
been produced by the subject’s clinical state, environmental or toxic factors, or other modes 
of therapy administered to the subject; or (3) it follows a known pattern of response to the 
test drug. 
PROBABLY: This category applies to those AEs that the investigator feels with a high 
degree of certainty are related to the test drug.  An AE may be considered probably related if 
or when it meets 3 of the following criteria: (1) it follows a reasonable temporal sequence 
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V5.0, 18 March 2021 
Confidential 
 
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from administration of the drug; (2) it could not be reasonably explained by the known 
characteristics of the subject’s clinical state, environmental or toxic factors, or other modes 
of therapy administered to the subject; (3) it disappears or decreases on cessation or reduction 
in dose (note that there are exceptions when an AE does not disappear upon discontinuation 
of the drug, yet drug-relatedness clearly exists; for example, as in bone marrow depression, 
fixed drug eruptions, or tardive dyskinesia); or (4) it follows a known pattern of response to 
the test drug. 
DEFINITELY: This category applies to those AEs that the investigator feels are 
incontrovertibly related to test drug.  An AE may be assigned an attribution of definitely 
related if or when it meets all of the following criteria: (1) it follows a reasonable temporal 
sequence from administration of the drug; (2) it could not be reasonably explained by the 
known characteristics of the subject’s clinical state, environmental or toxic factors, or other 
modes of therapy administered to the subject; (3) it disappears or decreases on cessation or 
reduction in dose and recurs with re-exposure to drug (if rechallenge occurs); and (4) it 
follows a known pattern of response to the test drug. 
 
When changes in the intensity of an AE occur more frequently than once a day, the maximum 
intensity for the event should be noted.  If the intensity category changes over a number of days, 
then those changes should be recorded separately (with distinct onset dates). 
The severity of AEs will be graded according to the National Cancer Institute Common 
Terminology Criteria for Adverse Events, Version 4.03 (NCI CTCAE V4.03) (Grades 1 to 5). 
12.5.2 Serious Adverse Events 
An AE is considered “serious” if it is judged by the Investigator or Sponsor to meet 1 or more of 
the following criteria:  
 Is fatal 
 Is life-threatening 
 Results in subject hospitalization or prolongation of existing hospitalization 
 Results in a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 
 Is a congenital anomaly/birth defect 
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 Other important medical events that may not be immediately life-threatening or result in 
death or hospitalization, but may jeopardize the subject and/or require medical or surgical 
intervention to prevent one of the outcomes listed above. 
Since SAEs are critically important for identification of significant safety problems, it is 
important to take into account both the Investigator’s and the Sponsor’s assessment.  If either the 
Sponsor or the Investigator believes that an event is serious, the event must be considered serious 
and evaluated by the Sponsor for expedited reporting.  Hospital admission or death caused by 
progressive disease will not be considered an SAE and do not require expedited reporting. For 
such cases, initial SAE report of signs or symptoms can be made, but once final diagnosis of PD 
is made for the underlying cause of sign or symptom, update of SAE report is required and likely 
to be retracted as result.   
The Investigator must notify the Ethics Review Committee/IRB of such an event in writing 
as soon as is practical and in accordance with international and local laws and regulations 
12.5.3 Serious Adverse Event Reporting 
All SAEs occurring during the period between the first dose and the last dose of GT0918 or EOS 
must be reported to the INC Pharmacovigilance Group and will be evaluated by the medical 
monitor and the Sponsor. The 30-day safety follow-up “window” is set to capture possible drug-
related AEs and SAE whereas unrelated SAEs should not be reported. When subject starts new 
therapy, the window of SAE report is closed simultaneously. All SAEs must be reported within 
24 hours of occurrence or when the Investigator becomes aware of the event unless the SAE is 
determined not related to study drug.  Notification can be made using the dedicated fax line 
and/or telephone line for the CRO Pharmacovigilance Group: 
INC Pharmacovigilance Fax:   
+1 877 464 7787 
INC Pharmacovigilance Contact:   
INCDrugSafety@INCResearch.com 
CRO, Inc.:   
 
 
 
Syneos Health (INC) 
Address:   
 
 
 
1030 Sync Street, Morrisville, NC  27560 
Telephone:  
 
 
 
+1 919 745 3026 
 
If the Investigator contacts the INC Pharmacovigilance Group by telephone, then a written report 
must follow within 1 business day and is to include a full description of the event and sequelae in 
the format detailed in the SAE reporting form. 
The event must also be recorded on the standard AE electronic CRF.  Preliminary reports of 
SAEs must be followed by detailed descriptions later on, including clear and anonymized 
photocopies of hospital case reports, consultant reports, autopsy reports, and other applicable 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
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V5.0, 18 March 2021 
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documents.  SAE reports must be made irrespective to whether or not the Investigator considers 
the event to be related to the investigational drug. 
Appropriate remedial measures should be taken to treat the SAE, and the response should be 
recorded.  Clinical, laboratory, and diagnostic measures should be employed as needed in order 
to determine the etiology of the problem.  The Investigator must report all additional follow-up 
evaluations to the CRO Pharmacovigilance Group within 10 calendar days.  All SAEs will be 
followed until the Investigator and Sponsor agree the event is satisfactorily resolved. 
Any SAE that is not resolved by the end of the study or upon discontinuation of the subject’s 
participation in the study is to be followed until it either resolves, stabilizes, returns to baseline 
values (if a baseline value is available), or is shown to not be attributable to the study drug or 
procedures. 
12.5.4 Overdose 
The Investigator must immediately notify the Sponsor and CRO Medical Monitor of any 
occurrence of overdose with study drug. 
12.5.5 Pregnancy 
Pregnancy occurring in the female partner of a subject participating in the study should be 
reported to the Investigator and the Sponsor. The reporting timeframe is from start of study drug 
up to 90 days after the last dose of study drug.  Pregnancy is not an SAE; however, the outcome 
of a pregnancy must be reported to detect a potential SAE (congenital anomaly, premature birth, 
or birth defect). Procedures and policies at the site and at the Sponsor, regarding pregnancies, 
will be followed to ensure that the safety and well-being of the fetus are appropriately followed 
through the pregnancy to birth. In the event that a pregnancy occurs, the Investigator will then 
(and only then) obtain the partner’s consent so that the Sponsor can hold her data on file. If the 
female partner is unwilling to sign the consent her data may not be held in the safety database. 
However, this will not affect the ability of the male subject to continue in the study.  
12.5.6 Safety Review and Teleconferences 
Safety review of AEs, laboratory data, concomitant medication, etc. will be performed by the 
study Medical Monitor on regular basis. Safety call and teleconferences will be held between the 
investigators/sites and medical monitor and Sponsor to discuss some important drug-related AEs 
and management of AEs/SAEs during the trial. The frequency may vary based on accrual and 
study activities. 
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Suzhou Kintor Pharmaceutical, Inc.                                                          Proxalutamide (GT0918)  
Protocol#: GT0918-US-1002 
 
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V5.0, 18 March 2021 
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13 STATISTICAL ANALYSIS 
A Statistical Analysis Plan (SAP) will be prepared after the protocol is approved.  This document 
will provide further details regarding the definition of analysis variables and analysis 
methodology to address all study objectives.  The SAP will serve as a compliment to the protocol 
and supersedes it in case of differences. 
The statistical evaluation will be performed using the Statistical Analysis Software (SAS®) 
Version 9.4 or higher (SAS Institute, Cary, NC).  All data will be listed, and summary tables will 
be provided.  Summary statistics will be presented by dose group.  For continuous variables, data 
will be summarized with the number of subjects (N), mean, standard deviation, median, 
minimum, and maximum by treatment group.  For categorical variables, data will be tabulated 
with the number and percentages of subjects for each category by treatment group. No interim 
analyses are planned for the Phase II dose expansion study.   
13.1 Determination of Sample size 
Phase II dose expansion stage consists of 2 arms of 30 subjects/arm, for a total of 60 subjects for 
Phase II.  Altogether, up to 60 subjects will be estimated for the randomization and stratified by 
prior medication (abiraterone or enzalutamide).  
Of note, the study does not allow disease progression on both abiraterone or enzalutamide. If 
prior treatment of one of these 2 drugs (i.e. abiraterone) only lasted less than 3 months due to 
toxicity, the subject (i.e. progressed on enzalutamide) is eligible and prior therapy of 
enzalutamide will be considered.  
 
13.2 Analysis Populations 
The Safety Analysis Set (SAF) will include all subjects who take at least 1 dose of study 
medication. Safety analyses will be conducted using the safety population.  
The Full Analysis Set (FAS) will include all evaluable subjects used as the supportive analysis 
population for efficacy. The FAS population will be used as the primary analysis population for 
efficacy. 
The Per Protocol (PP) Analysis Set will include all FAS subjects with the Week 12 PSA 
assessment and without major protocol violations.  
 
13.3 Demographic and Baseline Characteristics 
Data will be tabulated by #subjects (%) or Median (range) for the following variables: 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 54 of 79 
 # Subjects 
 Age in years - median (range) 
 Treatment of Primary Tumor, # (%) 
 Surgery  
 Radiation 
 No primary therapy 
 Prior hormonal therapy # (%) 
 1 line 
 2 lines 
 3 lines 
 >/= 4 lines 
 Prior chemotherapy # (%) 
 None 
 1 line (2 or more are excluded) 
Clinical State of Disease 
 PSA in ng/mL - median (range) 
 Sites of disease # (%) 
 Bone only 
 Bone and soft tissue 
 Soft tissue only 
 Soft tissue disease 
 Lymph node (LN) only  
 Visceral lesion only 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 55 of 79 
 Lymph node + visceral lesion 
 Other (pelvis/bladder) alone 
 Prior required hormonal treatment  
o abiraterone,  
o enzalutamide 
 
13.4 Efficacy Analysis 
Assessment of Efficacy Variables: 
1. Assessment of PSA: Blood samples will be collected to determine the serum total PSA 
concentration. 
2. Change of PSA from baseline:  
a. The percentage of change of PSA from baseline Week 12 will be calculated. 
Maximum percentage change of PSA from baseline at any time will be calculated. 
b. The proportion of subjects achieving a ≥50% reduction in PSA at 3 months (12 
weeks) as compared to baseline (study entry) will be determined. 
3. Assessment of soft tissue and bone: 
c. Soft tissue: Chest, abdomen, and pelvic CT, or MRI (if CT not possible), will be 
performed. Changes in the size of target lesions will be evaluated. 
d. Bone scan: Radionuclide bone scan will be performed. Changes in the number of 
lesions will be reported. 
e. Skeletal-related events: Severity of skeletal-related event (bone pain, analgesia 
intake) will be assessed monthly per PCWG2. 
4. Symptomatic progression will be evaluated by type. Symptomatic progression is defined 
as evidence of unequivocal symptomatic or clinical progression defined by at least 1 of 
the following: 
 A marked escalation in cancer-related pain that is assessed by the Investigator to 
indicate the need for other systemic therapy or palliative radiotherapy. Ignore early 
changes (≤ 12 weeks) in pain or health-related quality of life in absence of compelling 
evidence of disease progression. Confirm progression of pain or health-related quality 
of life ≥ 3 weeks later, 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 56 of 79 
 An immediate need for initiation of new anticancer treatment, surgical or radiological 
intervention for complications due to tumor progression, 
 A marked deterioration in ECOG performance status to Grade 3 or higher, or 
 Performance status: ECOG performance status will be assessed. Changes from 
baseline will be evaluated. 
 
13.5 Exploratory Analyses 
Assessment of Exploratory Variables:  
Exploratory markers will be taken at baseline and every 3 months during the study.  
The exploratory variables will be summarized using descriptive statistics. The descriptive 
statistics will include the actual values and the changes from baseline for the exploratory 
variables.  
13.6 Safety Analysis 
Assessment of safety will be based on the incidence of AEs, AEs resulting in discontinuation, 
and serious adverse events (SAEs) in each dose level. AEs will be coded using the Medical 
Dictionary for Regulatory Activities (MedDRA). Summaries of AEs will be provided showing 
the number and percentage of subjects who experienced at least 1 AE. These summaries will be 
presented by dose level, system organ class, and the preferred term. The occurrence of AEs will 
also be tabulated by severity and relationship to study medication. SAEs and AEs resulting in 
discontinuation will be summarized separately. All vital sign measurements, clinical laboratory 
results, pain score, and ECG findings will be summarized by dose level and time point using 
descriptive statistics or frequency distributions.  
All safety summaries will be performed by dose levels and by all subjects. 
13.7 Interim Analysis  
Not applicable 
13.8 Data Monitoring Committee 
Not applicable 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 57 of 79 
14 STUDY MANAGEMENT 
14.1 Approval and Consent 
14.1.1 Regulatory Guidelines 
This study will be conducted in accordance with the accepted version of the Declaration of 
Helsinki and/or all relevant federal regulations, as set forth in Parts 50, 56, 312, Subpart D, of 
Title 21 of the Code of Federal Regulations (CFR), and in compliance with GCP guidelines. 
14.1.2 Institutional Review Board/Independent Ethics Committee 
Conduct of the study must be approved by an appropriately constituted IRB/IEC.  Approval is 
required for the study protocol, investigational drug brochure, protocol amendments, informed 
consent forms (ICFs), and subject information sheets.  
14.1.3 Informed Consent  
For each study subject, written informed consent will be obtained prior to any protocol-related 
activities.  As part of this procedure, the Principal Investigator or one of his/her associates must 
explain orally and in writing the nature, duration, and purpose of the study, and the action of the 
drug in such a manner that the subject is aware of the potential risks, inconveniences, or adverse 
effects that may occur.  The subject should be informed that he/she may withdraw from the study 
at any time, and the subject will receive all information that is required by local regulations and 
International Conference on Harmonization (ICH) guidelines.  The PI will provide the Sponsor 
or its representative with a copy of the IRB/IEC-approved ICF prior to the start of the study. 
Should changes to the Informed Consent form become necessary during the study, the PI will 
ensure that the changes are approved by the sponsor or its representative prior to submission to 
the IRB.  All revisions of the protocol must be reflected in the IC form, if applicable, and 
reviewed by the IRB. Subjects must be made aware of those applicable changes in the protocol 
and must consent to participate in the revised protocol. 
14.1.4 Subject Confidentiality 
All communications, reports, and subject samples will be identified by site number, and a code 
number and/or initials to maintain subject confidentiality. All records will be kept confidential to 
the extent permitted by law. If a waiver or authorization separate from the statement in the 
Informed Consent is required for permitting access to a subject’s medical records (e.g. HIPAA), 
the Investigator will obtain such authorization prior to enrolling a subject in the study. The PI 
should keep a separate log of subjects, codes, names, and addresses. Documents which identify 
the subject by name (for example, the Informed Consent form) should be kept in strict 
confidence. 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 58 of 79 
The sponsor and its business associates agree to keep all subject information confidential. Data 
resulting from analyses will be entered into a database that is not accessible to the public. Subject 
data will be identified only by the subject screen number, randomization number and initials, and 
not by any other annotation or identifying information.  
The sponsor and its business associates will take every possible step to reduce the risk of 
releasing information to the public that would enable subjects to be personally identified.  
14.2 Data Handling  
Any data to be recorded directly on the eCRFs (to be considered as source data) will be 
identified at the start of the study.  Data reported on the eCRF that are derived from source 
documents should be consistent with the source documents, or the discrepancies must be 
explained. 
Clinical data will be entered on eCRFs for transmission to the Sponsor. Data on eCRFs 
transmitted via the web-based data system must correspond to and be supported by source 
documentation maintained at the study site, unless the study site makes direct data entry to the 
databases for which no other original or source documentation is maintained.  In such cases, the 
study site should document which eCRFs are subject to direct data entry and should have in 
place procedures to obtain and retain copies of the information submitted by direct data entry.  
All study forms and records transmitted to the Sponsor must carry only coded identifiers such 
that personally identifying information is not transmitted.  The primary method of data 
transmittal is via the secure, internet-based electronic data capture (EDC) system maintained by 
the Sponsor.  Access to the EDC system is available to authorized users via the study’s Internet 
web site, where an assigned username and password are required for access.  The eCRFs will be 
considered complete when all missing and/or incorrect data have been resolved.  
14.3 Source Documents 
Source documents are considered to be all information in original records and certified copies of 
original records of clinical findings, observations, data or other activities in a clinical study 
necessary for the reconstruction and evaluation of the study.  Source documents are filed and 
kept secure by the Investigator at each research site and can be obtained by contacting the 
Investigator to arrange access. 
14.4 Record Retention 
Study records and source documents must be preserved for at least 15 years after the completion 
or discontinuation of/withdrawal from the study or 2 years after the last approval of a marketing 
application in an ICH region, whichever is the longer time period. 
The investigator agrees to comply with all applicable federal, state, and local laws and 
regulations relating to the privacy of subject health information, including, but not limited to, the 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 59 of 79 
Standards for Individually Identifiable Health Information, 45 CFR, Parts 160 and 164 (the 
Health Insurance Portability Accountability Act of 1996 [HIPAA] Privacy Regulation).  The 
Investigator shall ensure that study subjects authorize the use and disclosure of protected health 
information in accordance with HIPAA Privacy Regulation and in a form satisfactory to the 
Sponsor. 
14.5 Monitoring 
The study will be monitored to ensure that it is conducted and documented properly according to 
the protocol, GCP, and all applicable regulatory requirements.  
On-site monitoring visits will be made at appropriate times during the study.  Clinical monitors 
must have direct access to source documentation in order to check the completeness, clarity, and 
consistency of the data recorded in the eCRFs for each subject.   
The Investigator will make available to the clinical monitor source documents and medical 
records necessary to complete eCRFs.  In addition, the Investigator will work closely with the 
clinical monitor and, as needed, provide them appropriate evidence that the conduct of the study 
is being done in accordance with applicable regulations and GCP guidelines.  
14.6 Quality Control and Quality Assurance 
The Sponsor or its designee will perform the quality assurance and quality control activities of 
this study; however, responsibility for the accuracy, completeness, and reliability of the study 
data presented to the Sponsor lies with the Investigator generating the data. 
The Sponsor will arrange audits as part of the implementation of quality assurance to ensure that 
the study is being conducted in compliance with the protocol, Standard Operating Procedures, 
GCP, and all applicable regulatory requirements.  Audits will be independent of and separate 
from the routine monitoring and quality control functions.  Quality assurance procedures will be 
performed at study sites and during data management to assure that safety and efficacy data are 
adequate and well documented.  
14.7 Protocol Amendment and Protocol Deviation  
14.7.1 Protocol Amendment 
Amendments to the protocol that entail corrections of typographical errors, clarifications of 
confusing wording, changes in study personnel, and minor modifications that have no impact on 
the safety of subjects or the conduct of the study will be classified as administrative amendments 
and will be submitted to the IRB/IEC for information only.  The Sponsor will ensure that 
acknowledgement is received and filed.  Amendments that are classed as substantial amendments 
must be submitted to the appropriate Regulatory Authorities and the IRBs/IECs for approval. 
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Page 60 of 79 
 
14.7.2 Protocol Deviations 
Should a protocol deviation occur, the Sponsor, medical monitor and/or the CRO study manager 
must be informed as soon as possible.  Protocol deviations and/or violations and the reasons they 
occurred will be included in the clinical study report.  Reporting of protocol deviations to the 
IRB/IEC and in accordance with applicable Regulatory Authority mandates is an Investigator 
responsibility. 
14.8 Ethical Considerations 
This study will be conducted in accordance with the accepted version of the Declaration of 
Helsinki and/or all relevant federal regulations, as set forth in Parts 50, 56, 312, Subpart D, of 
Title 21 of the CFR, and in compliance with GCP guidelines. 
IRBs/IECs will review and approve this protocol and the ICF.  All subjects are required to give 
written informed consent prior to participation in the study.   
14.9 Financing and Insurance 
Prior to the study commencing, the Sponsor (or its designee) and the Investigator (or the 
institution, as applicable) will agree on costs necessary to perform the study.  This agreement 
will be documented in a financial agreement that will be signed by the Investigator (or the 
institution signatory) and the Sponsor (or its designee).  
The Investigator is required to have adequate current insurance to cover claims for negligence 
and/or malpractice.  The Sponsor will provide insurance coverage for the clinical study as 
required by national regulations. 
14.10 Publication Policy / Disclosure of Data  
Both the use of data and the publication policy are detailed within the clinical study agreement.  
Intellectual property rights (and related matters) generated by the Investigator and others 
performing the clinical study will be subject to the terms of a clinical study agreement that will 
be agreed between the Institution and the Sponsor or their designee.  With respect to such rights, 
the Sponsor or its designee will solely own all rights and interests in any materials, data, and 
intellectual property rights developed by Investigators and others performing the clinical study 
described in this protocol, subject to the terms of any such agreement.  In order to facilitate such 
ownership, Investigators will be required to assign all such inventions either to their Institution 
or directly to the Sponsor or its designee, as will be set forth in the clinical study agreement. 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 61 of 79 
15 REFERENCES 
General references for prostate cancer:   
1. NCCN 2015 Prostate Cancer Guidelines 
2. Merck Manual Professional Version online at 
http://www.merckmanuals.com/professional/genitourinary-disorders/genitourinary-
cancer/prostate-cancer  
3. PDQ General Information about Prostate Cancer at 
http://www.cancer.gov/types/prostate/hp/prostate-treatment-pdq  
4. XTANDI package insert 9/2014 and 10/2015 
5. MHE Tan et al., Androgen receptor: structure, role in prostate cancer and drug discovery.  
Acta Pharmacologica Sinica (2015) 36: 3-23. 
6. Oken MM, et al 1982.  Toxicity and response criteria of the Eastern Cooperative Oncology 
Group. Am J Clin Oncol 5:649-655 
7. Eisenhauer et al.  New response evaluation criteria in solid tumors: Revised RECIST 
guideline (version 1.1).  Eur J Can 45 (2009) 228-247. 
 
 
 
 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 62 of 79 
16 APPENDICES 
16.1 Schedule of Assessments 1 
 
Screening
Cycle 1-6 
Additional 
Cycles 7-30 12
EOS 14 
Safety F/U15
Study Day 
Day -21 
to 
Day -1 
Day 
1 
C1D1 
Day 
15 
C1D15
Day 
29 
C2D1 
Day 
57 
C3D1 
Day 
85 
C4D1 
Day 
113 
C5D1 
Day 
141 
C6D1 
Day 169/C7D1
End-of-6 
month 
 From Day 169 
(every 4 wks.) 
Over 30 days 
after last 
dose 
30 days 
after last 
dose  
Assessments 
Weeks 
w1 
w3 
w5 
w9 
w13 
w17 
w21 
w25 
 
 
 
Informed Consent 
X 
  
 
  
  
  
  
  
 
  
  
  
Inclusion/Exclusion 
X 
X  
 
  
  
  
  
  
 
  
  
  
Medical History 2 
X 
X 
 
  
  
  
  
  
 
  
  
  
CT/MRI/Bone Scan 3 
X 
 
 
 
 
X 
 
 
X 
X 13 
 
 
Vital Signs 4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Physical Exam 5 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
ECOG performance status 6 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Clinical Chemistry & 
electrolytes 7 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Hematology 7 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Lipid Profile & blood glucose 8 
X 
X 
 
X 
X 
X 
X 
X 
X 
     X 13 
 
 
Urinalysis 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
PSA 9 
X 
X 
 
 X 
X  
X 
X 
X 
X 
X 
 
 
Testosterone 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
12-lead ECG 10 
X 
X 
 
X 
 
X 
 
 
X 
X 13 
x 
 
PT/PTT/INR 
X 
 
 
 
 
 X 
 
 
X 
     
 
 
Exploratory markers 11 
 
X 
 
  
 
X 
 
  
X 
X 13 
X 
  
Adverse Events 
  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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Protocol#: GT0918-US-1002 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
Confidential 
 
Page 63 of 79 
Concomitant Meds16 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Study Drug Disposition 
  
X 
X 
X 
X  
X 
X 
X  
 
X 
  
  
Study Drug Treatment  
  
X 
X 
X 
X 
X 
X 
X 
X 
X 
  
  
Compliance Assessment  
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X  
 
Abbreviations: ECOG=Eastern Cooperative Oncology Group; ECG=electrocardiogram; PT/PTT/INR=Prothrombin Time/ 
Partial Prothrombin Time/International Normalized Ratio; CT=Computed tomography; MRI=Magnetic 
resonance imaging; PSA=prostate surface antigen; EOS=End-of-Study.  
Note: For days not specifically designated on the schedule of assessments, the standard of care for the individual institution will be followed, any 
AEs and concomitant medications will be recorded on the CRF. 
1. This schedule applies to Phase II study of GT0918 including screening, treatment of first 6 cycles and additional cycles for eligible subjects. 
One cycle constitutes 4 weeks of treatment. See Section 9.2 Expanded/Phase II Study Visits. 
2. Full medical and surgical history will be recorded at Screening. At Cycle 1, Day 1; an interim history prior to first dose of study drug is to be 
recorded as concomitant illness. 
3. Imaging that is performed during standard care within 6 weeks of Cycle 1 Day 1 prior to informed consent may be used to confirm screening 
requirements. Disease status will be measured by radiologic methods (CT or MRI or bone scan) at screening, and every 3 cycles, i.e. 84 days 
(+/- 14 days) after Day 1. No subject is permitted to have additional cycles until it is confirmed that disease progression has not occurred.  
4. Vital signs will include weight, height (Screening only), BSA (Screening only), body temperature, respiratory rate, radial pulse rates, and 
systolic/diastolic blood pressures. 
5. Complete physical examinations will be conducted at Screening (Day -28 to Day -1), on Days 85 (C4D1) and 169 (C7D1), on every 3 months 
during the extension study. All other physical examinations will be abbreviated. Complete physical examinations will include examination of 
general appearance, skin, neck (including thyroid), eyes, nose, throat, heart, lungs, abdomen, lymph nodes, extremities, muscular skeletal and 
nervous system. Abbreviated physical examinations will focus on new symptoms and will include examinations identified as relevant by the 
investigator. PE record if subject complains bone pain, compromised urinary or bowel movements. For bone pain, location and severity are 
needed in CRF. If pain killers are taken, names, dosage, and frequency use are noted under concomitant medication in CRF.  
6. After Cycle 1, ECOG performance status will be assessed every cycle (4 weeks) during Cycles 2-6 and extension cycles, and at EOS/ET Visits. 
7. Hematology and chemistry assessments will be done as defined with a window of (±3 days) every cycle (4 weeks). 
8. Fasting lipid and glucose will be done at Screening, and on Days 1, 29, 57, 85, 113, 141, and 169 (±3 days) in Cycle 1-6. For extension cycles, 
lipid profile and blood glucose are to be assessed every 3 cycles (12 weeks).  For subjects with abnormal lipid profiles, monthly testing is 
required in extension cycles. 
9. PSA will be processed in local lab. 
10. ECGs will be performed in triplicate at Screening, on Cycle 1 Day 1 and Cycle 2 Day 1 (Day 29). Single ECGs are to be conducted on Day 
85, 169, and quarterly (every 3 month) during additional cycles. For any subject with abnormal or questionable ECG, monthly monitoring ECG 
is required. If there is reading error, artifacts or suspicious readings, triplicate readings with at least 15 min between each reading are 
recommended. The final test result will take the average of 3 readouts. 
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GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
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Page 64 of 79 
11. Exploratory markers of circulating tumor cells, ct-DNA and ct-RNA will be assessed every 3 cycles and at EOS/ET. 
12. Subjects are eligible for additional cycles in a 6-month Extension Study if they complete 6 cycles of treatment and have “no disease 
progression”. The same dose levels will be kept for the additional cycles. Subjects will be assessed by Investigator/Medical Monitor or/and 
Sponsor at the end every 6 cycles (end-of-6/12/18/24 cycles) to be determined if to proceed into the next 6 cycle treatments. Subjects are 
required to have office visits monthly (every 4 weeks +/- 3days) and all assessments marked with “X” will be performed every 4 weeks unless 
specified otherwise.  
13. CT/MRI/bone scan, ECG, and exploratory markers will be assessed every 12 weeks. TSH/T3/T4 and PT/PTT/INR will be assessed every 12 
weeks only in the first 6 cycles. 
14. EoS is used for subjects on study drug GT0918. If EoS is equal to or less than 30 days from previous scheduled visit or to next planned visit, the 
EoS visit can be either omitted or combined. 
15. Safety follow-up is recommended 30 days after last dose of study drug GT0918 or/and EoS whichever occurs later for any possibly delayed 
drug-related SAE. For drug-related AE/SAE should be followed up until complete resolution or equal to level of baseline. 
16. In concomitant medication, specify if pain medications are taken or not. If so, list name, dosage, frequency, etc.  
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
Protocol#: GT0918-US-1002 
 
 
GT0918 expanded/phase II Study 
V5.0, 18 March 2021 
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Page 65 of 79 
16.2 APPENDIX 1:  ECOG Performance Status 
 
   
ECOG Performance Status Scale 
 
Grade 
 
Descriptions 
0 
Normal activity.  Fully active, able to carry on all pre-
disease performance without restriction. 
1 
Symptoms, but ambulatory.  Restricted in physically 
strenuous activity, but ambulatory and able to carry out 
work of a light or sedentary nature (e.g., light housework, 
office work). 
2 
In bed <50% of the time.  Ambulatory and capable of all 
self-care, but unable to carry out any work activities.  Up 
and about more than 50% of waking hours. 
3 
In bed >50% of the time.  Capable of only limited self-
care, confined to bed or chair more than 50% of waking 
hours. 
4 
100% bedridden.  Completely disabled.  Cannot carry on 
any self-care.  Totally confined to bed or chair. 
5 
Dead. 
 
Source:  Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. 
1982.  Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin 
Oncol 5:649-655.  
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
Protocol#: GT0918-US-1002 
 
 
GT0918 expanded/phase II Study 
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Page 66 of 79 
16.3 APPENDIX 2:  RECIST Guidelines v1.1 
 
EA Eisenhauer et al.  New response evaluation criteria in solid tumors: 
Revised RECIST guideline (version 1.1).  Eur J Can 45 (2009) 228-247. 
Key sections of the article are included here as a guideline.  It is strongly recommended; 
however, to read the entire article, since it highlights the changes from v1.0 and gives many 
useful examples. 
Measurability of tumor at baseline 
Definitions 
At baseline, tumor lesions/lymph nodes will be categorized measurable or non-measurable as 
follows: 
Measurable  
Tumor lesions must be accurately measured in at least one dimension (longest diameter in the 
plane of measurement is to be recorded) with a minimum size of:  
 10 mm by CT scan (CT scan slice thickness no less than 5 mm for spirals). 
 10 mm caliper measurement by clinical exam (lesions which cannot be accurately 
measured with calipers should be recorded as non-measurable). 
Malignant lymph nodes: 
 To be considered pathologically enlarged and measurable, a lymph node must be >/= 15 
mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be 
no greater than 5 mm). At baseline and in follow-up, only the short axis will be measured 
and followed. See also notes below on ‘Baseline documentation of target and non-target 
lesions’ for information on lymph node measurement. 
 
Non-measurable 
All other lesions, including small lesions (longest diameter < 10 mm or pathological lymph 
nodes with >/= 10 to < 15 mm short axis) as well as truly non-measurable lesions. Lesions 
considered truly non-measurable include: leptomeningeal disease, ascites, pleural or pericardial 
effusion, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
Protocol#: GT0918-US-1002 
 
 
GT0918 expanded/phase II Study 
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Page 67 of 79 
masses/abdominal organomegaly identified by physical exam that is not measurable by 
reproducible imaging techniques. 
Special considerations regarding lesion measurability 
Bone lesions, cystic lesions, and lesions previously treated with local therapy require particular 
comment: 
Bone lesions: 
 Bone scan, PET scan or plain films are not considered adequate imaging techniques to 
measure bone lesions. However, these techniques can be used to confirm the presence or 
disappearance of bone lesions. 
 Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components 
that can be evaluated by cross-sectional imaging techniques such as CT or MRI can be 
considered as measurable lesions if the soft tissue component meets the definition of 
measurability described above. 
 Blastic bone lesions are non-measurable. 
Cystic lesions: 
 Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) since they are, 
by definition, simple cysts. 
 ‘Cystic lesions’ thought to represent cystic metastases can be considered as measurable 
lesions, if they meet the definition of measurability described above. However, if non-
cystic lesions are present in the same subject, these are preferred for selection as target 
lesions. 
Lesions with prior local treatment: 
 Tumor lesions situated in a previously irradiated area, or in an area subjected to other 
loco-regional therapy, are usually not considered measurable unless there has been 
demonstrated progression in the lesion. Study protocols should detail the conditions 
under which such lesions would be considered measurable. 
Specifications by methods of measurements 
Measurement of lesions 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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All measurements should be recorded in metric notation, using calipers if clinically assessed. All 
baseline evaluations should be performed as close as possible to the treatment start and never 
more than 4 weeks before the beginning of the treatment. 
Method of assessment 
The same method of assessment and the same technique should be used to characterize each 
identified and reported lesion at baseline and during follow-up. Imaging based evaluation should 
always be done rather than clinical examination unless the lesion(s) being followed cannot be 
imaged but are assessable by clinical exam. 
Clinical lesions: 
 Clinical lesions will only be considered measurable when they are superficial and >/= 10 
mm diameter as assessed using calipers (e.g. skin nodules). For the case of skin lesions, 
documentation by color photography including a ruler to estimate the size of the lesion is 
suggested. As noted above, when lesions can be evaluated by both clinical exam and 
imaging, imaging evaluation should be undertaken since it is more objective and may 
also be reviewed at the end of the study. 
CT, MRI: 
 CT is the best currently available and reproducible method to measure lesions selected 
for response assessment. This guideline has defined measurability of lesions on CT scan 
based on the assumption that CT slice thickness is 5 mm or less.  When CT scans have 
slice thickness greater than 5 mm, the minimum size for a measurable lesion should be 
twice the slice thickness. If there is concern about radiation exposure or dye with CT, 
MRI may be used instead of CT in selected instances.  
Ultrasound: 
 Ultrasound is not useful in assessment of lesion size and should not be used as a method 
of measurement. Ultrasound examinations cannot be reproduced in their entirety for 
independent review at a later date and, because they are operator dependent, it cannot be 
guaranteed that the same technique and measurements will be taken from one assessment 
to the next. If new lesions are identified by ultrasound in the course of the study, 
confirmation by CT or MRI is advised. 
Endoscopy, laparoscopy: 
 The utilization of these techniques for objective tumor evaluation is not advised. 
However, they can be useful to confirm complete pathological response when biopsies 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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Page 69 of 79 
are obtained or to determine relapse in trials where recurrence following complete 
response or surgical resection is an endpoint. 
Tumor markers: 
 Tumor markers alone cannot be used to assess objective tumor response. If markers are 
initially above the upper normal limit, however, they must normalize for a subject to be 
considered in complete response. Because tumor markers are disease specific, 
instructions for their measurement should be incorporated into protocols on a disease 
specific basis. Specific guidelines for both CA-125 response (in recurrent ovarian cancer) 
and PSA response (in recurrent prostate cancer), have been published. In addition, the 
Gynecologic Cancer Intergroup has developed CA125 progression criteria which are to 
be integrated with objective tumor assessment for use in first-line trials in ovarian cancer.  
Cytology, histology: 
 These techniques can be used to differentiate between PR and CR in rare cases if required 
by protocol (for example, residual lesions in tumor types such as germ cell tumors, where 
known residual benign tumors can remain). When effusions are known to be a potential 
adverse effect of treatment (e.g. with certain taxane compounds or angiogenesis 
inhibitors), the cytological confirmation of the neoplastic origin of any effusion that 
appears or worsens during treatment can be considered if the measurable tumor has met 
criteria for response or stable disease in order to differentiate between response (or stable 
disease) and progressive disease. 
Tumor response evaluation 
Assessment of overall tumor burden and measurable disease 
To assess objective response or future progression, it is necessary to estimate the overall tumor 
burden at baseline and use this as a comparator for subsequent measurements. Only subjects with 
measurable disease at baseline should be included in protocols where objective tumor response is 
the primary endpoint. Measurable disease is defined by the presence of at least one measurable 
lesion (as detailed above). In studies where the primary endpoint is tumor progression (either 
time to progression or prostage with progression at a fixed date), the protocol must specify if 
entry is restricted to those with measurable disease or whether subjects having non-measurable 
disease only are also eligible. 
 
Baseline documentation of ‘target’ and ‘non-target’ lesions 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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When more than one measurable lesion is present at baseline all lesions up to a maximum of five 
lesions total (and a maximum of two lesions per organ) representative of all involved organs 
should be identified as target lesions and will be recorded and measured at baseline (this means 
in instances where subjects have only one or two organ sites involved a maximum of two and 
four lesions respectively will be recorded).  
Target lesions should be selected on the basis of their size (lesions with the longest diameter), be 
representative of all involved organs, but in addition should be those that lend themselves to 
reproducible repeated measurements. It may be the case that, on occasion, the largest lesion does 
not lend itself to reproducible measurement in which circumstance the next largest lesion which 
can be measured reproducibly should be selected.  
Lymph nodes merit special mention since they are normal anatomical structures which may be 
visible by imaging even if not involved by tumor. As noted in Section 3, pathological nodes 
which are defined as measurable and may be identified as target lesions must meet the criterion 
of a short axis of >/= 15 mm by CT scan. Only the short axis of these nodes will contribute to the 
baseline sum. The short axis of the node is the diameter normally used by radiologists to judge if 
a node is involved by solid tumor. Nodal size is normally reported as two dimensions in the 
plane in which the image is obtained (for CT scan this is almost always the axial plane; for MRI 
the plane of acquisition may be axial, sagittal or coronal). The smaller of these measures is the 
short axis. For example, an abdominal node which is reported as being 20 mm x 30 mm has a 
short axis of 20 mm and qualifies as a malignant, measurable node. In this example, 20 mm 
should be recorded as the node measurement. All other pathological nodes (those with short axis 
</= 10 mm but <15 mm) should be considered non-target lesions. Nodes that have a short axis 
<10 mm are considered non-pathological and should not be recorded or followed. 
A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target 
lesions will be calculated and reported as the baseline sum diameters. If lymph nodes are to be 
included in the sum, then as noted above, only the short axis is added into the sum. The baseline 
sum diameters will be used as reference to further characterize any objective tumor regression in 
the measurable dimension of the disease.  
All other lesions (or sites of disease) including pathological lymph nodes should be identified as 
non-target lesions and should also be recorded at baseline. Measurements are not required and 
these lesions should be followed as ‘present’, ‘absent’, or in rare cases ‘unequivocal progression’ 
(more details to follow). In addition, it is possible to record multiple non-target lesions involving 
the same organ as a single item on the case record form (e.g. ‘multiple enlarged pelvic lymph 
nodes’ or ‘multiple liver metastases’). 
Response criteria 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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This section provides the definitions of the criteria used to determine objective tumor response 
for target lesions. 
Evaluation of target lesions 
 Complete Response (CR): Disappearance of all target lesions. Any pathological lymph 
nodes (whether target or non-target) must have reduction in short axis to < 10 mm. 
 Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, 
taking as reference the baseline sum diameters. 
 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target 
lesions, taking as reference the smallest sum on study (this includes the baseline sum if 
that is the smallest on study). In addition to the relative increase of 20%, the sum must 
also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or 
more new lesions is also considered progression). 
 Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase 
to qualify for PD, taking as reference the smallest sum diameters while on study.  
Special notes on the assessment of target lesions 
Lymph nodes. Lymph nodes identified as target lesions should always have the actual short axis 
measurement recorded (measured in the same anatomical plane as the baseline examination), 
even if the nodes regress to below 10 mm on study. This means that when lymph nodes are 
included as target lesions, the ‘sum’ of lesions may not be zero even if complete response criteria 
are met, since a normal lymph node is defined as having a short axis of < 10 mm. Case report 
forms or other data collection methods may therefore be designed to have target nodal lesions 
recorded in a separate section where, in order to qualify for CR, each node must achieve a short 
axis <10 mm. For PR, SD and PD, the actual short axis measurement of the nodes is to be 
included in the sum of target lesions. 
Target lesions that become ‘too small to measure’. While on study, all lesions (nodal and non-
nodal) recorded at baseline should have their actual measurements recorded at each subsequent 
evaluation, even when very small (e.g. 2 mm). However, sometimes lesions or lymph nodes 
which are recorded as target lesions at baseline become so faint on CT scan that the radiologist 
may not feel comfortable assigning an exact measure and may report them as being ‘too small to 
measure’. When this occurs it is important that a value be recorded on the case report form. If it 
is the opinion of the radiologist that the lesion has likely disappeared, the measurement should be 
recorded as 0 mm. If the lesion is believed to be present and is faintly seen but too small to 
measure, a default value of 5 mm should be assigned (Note: It is less likely that this rule will be 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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used for lymph nodes since they usually have a definable size when normal and are frequently 
surrounded by fat such as in the retroperitoneum; however, if a lymph node is believed to be 
present and is faintly seen but too small to measure, a default value of 5 mm should be assigned 
in this circumstance as well). This default value is derived from the 5 mm CT slice thickness (but 
should not be changed with varying CT slice thickness). The measurement of these lesions is 
potentially non-reproducible, therefore providing this default value will prevent false responses 
or progressions based upon measurement error. To reiterate, however, if the radiologist is able to 
provide an actual measure, that should be recorded, even if it is below 5 mm. 
Lesions that split or coalesce on treatment. When non-nodal lesions ‘fragment’, the longest 
diameters of the fragmented stages should be added together to calculate the target lesion sum. 
Similarly, as lesions coalesce, a plane between them may be maintained that would aid in 
obtaining maximal diameter measurements of each individual lesion. If the lesions have truly 
coalesced such that they are no longer separable, the vector of the longest diameter in this 
instance should be the maximal longest diameter for the ‘coalesced lesion’. 
Evaluation of non-target lesions 
This section provides the definitions of the criteria used to determine the tumor response for the 
group of non-target lesions. While some non-target lesions may actually be measurable, they 
need not be measured and instead should be assessed only qualitatively at the time points 
specified in the protocol.  
 
 Complete Response (CR): Disappearance of all non-target lesions and normalization of 
tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short 
axis). 
 Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of 
tumor marker level above the normal limits. 
 Progressive Disease (PD): Unequivocal progression (see comments below) of existing 
non-target lesions. (Note: the appearance of one or more new lesions is also considered 
progression). 
Special notes on assessment of progression of nontarget disease 
The concept of progression of non-target disease requires additional explanation as follows: 
When the subject also has measurable disease. In this setting, to achieve ‘unequivocal 
progression’ on the basis of the non-target disease, there must be an overall level of substantial 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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worsening in non-target disease such that, even in presence of SD or PR in target disease, the 
overall tumor burden has increased sufficiently to merit discontinuation of therapy. A modest 
‘increase’ in the size of one or more non-target lesions is usually not sufficient to quality for 
unequivocal progression status. The designation of overall progression solely on the basis of 
change in non-target disease in the face of SD or PR of target disease will therefore be extremely 
rare. 
When the subject has only non-measurable disease. This circumstance arises in some Phase 3 
trials when it is not a criterion of study entry to have measurable disease. The same general 
concepts apply here as noted above, however, in this instance there is no measurable disease 
assessment to factor into the interpretation of an increase in non-measurable disease burden. 
Because worsening in non-target disease cannot be easily quantified (by definition: if all lesions 
are truly non-measurable) a useful test that can be applied when assessing subjects for 
unequivocal progression is to consider if the increase in overall disease burden based on the 
change in non-measurable disease is comparable in magnitude to the increase that would be 
required to declare PD for measurable disease: i.e. an increase in tumor burden representing an 
additional 73% increase in ‘volume’ (which is equivalent to a 20% increase diameter in a 
measurable lesion). Examples include an increase in a pleural effusion from ‘trace’ to ‘large’, an 
increase in lymphangitic disease from localized to widespread, or may be described in protocols 
as ‘sufficient to require a change in therapy’. If ‘unequivocal progression’ is seen, the subject 
should be considered to have had overall PD at that point. While it would be ideal to have 
objective criteria to apply to non-measurable disease, the very nature of that disease makes it 
impossible to do so, therefore the increase must be substantial. 
 
New lesions 
The appearance of new malignant lesions denotes disease progression; therefore, some 
comments on detection of new lesions are important. There are no specific criteria for the 
identification of new radiographic lesions; however, the finding of a new lesion should be 
unequivocal: i.e. not attributable to differences in scanning technique, change in imaging 
modality or findings thought to represent something other than tumor (for example, some ‘new’ 
bone lesions may be simply healing or flare of pre-existing lesions). This is particularly 
important when the subject’s baseline lesions show partial or complete response. For example, 
necrosis of a liver lesion may be reported on a CT scan report as a ‘new’ cystic lesion, which it is 
not. 
A lesion identified on a follow-up study in an anatomical location that was not scanned at 
baseline is considered a new lesion and will indicate disease progression. An example of this is 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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the subject who has visceral disease at baseline and while on study has a CT or MRI brain 
ordered which reveals metastases. The subject’s brain metastases are considered to be evidence 
of PD even if he/she did not have brain imaging at baseline.  
If a new lesion is equivocal, for example because of its small size, continued therapy and follow-
up evaluation will clarify if it represents truly new disease. If repeat scans confirm there is 
definitely a new lesion, then progression should be declared using the date of the initial scan.  
While FDG-PET response assessments need additional study, it is sometimes reasonable to 
incorporate the use of FDG-PET scanning to complement CT scanning in assessment of 
progression (particularly possible ‘new’ disease). New lesions on the basis of FDG-PET imaging 
can be identified according to the following algorithm: 
 Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of PD 
based on a new lesion. 
 No FDG-PET at baseline and a positive FDG-PET at follow-up:  
 If the positive FDG-PET at follow-up corresponds to a new site of disease confirmed by 
CT, this is PD.  
 If the positive FDG-PET at follow-up is not confirmed as a new site of disease on CT, 
additional follow-up CT scans are needed to determine if there is truly progression 
occurring at that site (if so, the date of PD will be the date of the initial abnormal FDG-
PET scan). 
 If the positive FDG-PET at follow-up corresponds to a pre-existing site of disease on CT 
that is not progressing on the basis of the anatomic images, this is not PD. 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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16.4 APPENDIX 3:  New York Heart Association Classifications 
 
 
 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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16.5 APPENDIX 4:  Drugs with Potential Interactions with Metabolism 
GT0918 is CYP 3A4 inhibitor and it has potential of drug interactions. For all study subjects 
on any drug on this table, an alternative treatment shall be considered. If there is no 
alternative for the drug or the drug must be used as part of standard of care during the 
trial, for the sake of safety for study subject, the dose of drug must be adjusted or reduced,  
CYP 3A inhibitors  
Boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, 
lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, 
telaprevir, telithromycin, voriconazole 
 
CYP 2D6 inhibitors 
Bupropion, fluoxetine, paroxetine, quinidine  
 
CYP 3A inducers 
Avasimibe, carbamazepine, phenytoin, rifampin, St. John’s wort 
 
CYP 3A4 substrates 
 
Amlodipine/felodipine/nifedipine, Amiodarone, Apixaban/dabigatran/rivaroxaban, 
Atorvastatin/lovastatin/simvastatin, Diltiazem/verapamil, Edoxaban, Isosorbide 
dinitrate/mononitrate, Ivabradine, Ticagrelor, Warfarin 
 
 
 
 
 
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Suzhou Kintor Pharmaceutical, Inc.                                                                                                GT0918 
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16.6 APPENDIX 5:  Ingredients of GT0918 Drug Product 
 
Ingredients 
Dosage (mg) 
Proportion (%) 
ProxalutamideGT0918 (API) 
100.0 
30.49% 
Corn Starch 
192.8 
58.78% 
Hyposubstituted Hydroxypropyl 
Cellulose 
12.8 
3.90% 
Hydroxypropyl Methylcellulose E6 
9.6 
2.93% 
Magnesium Stearate 
4.8 
1.46% 
Film Coating Premix (gastric 
soluble) ®85G640066 
8.0 
2.44% 
 
 
 
 
 
 
 
 
 
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ICF_001.pdf: 
 
ICF Version: V5.0, dated 18Mar2021 
Page 1 of 12 
 
RESEARCH SUBJECT INFORMATION AND CONSENT FORM 
Phase II subjects ONLY 
 
 
TITLE: 
An Expanded /Phase II, Multi-Center, Randomized, Open-Label, Study to 
Evaluate the Safety and Tolerability of Proxalutamide (GT0918) in 
Subjects with Metastatic Hormone Sensitive Prostate Cancer (mHSPC) 
and Metastatic Castrate Resistant Prostate Cancer (mCRPC) who Failed 
Either Abiraterone or Enzalutamide 
 
PROTOCOL NO.: 
GT0918-US-1002 – Expanded phase II 
 
WIRB® Protocol #20152501 
 
SPONSOR: 
Suzhou Kintor Pharmaceutical, Inc. 
 
ICF VERSION #: 
V5.0, dated 18Mar2021 
 
INVESTIGATOR: 
Name 
 
Address 
 
City, State Zip 
 
Country 
 
STUDY-RELATED 
PHONE NUMBER(S):  
Name 
 
Phone Number(s) (24 Hours) 
 
[24-hour number required] 
 
 
A person who takes part in a research study is called a research or study subject. In this consent form "you" 
always refers to the research subject. 
 
SUMMARY 
You are being asked to be in a research study. The purpose of this consent form is to help you decide if you 
want to be in the research study. 
 
You should not join this research study until you fully understand this document and all of your questions 
are answered. You may want to discuss it with your family, friends or family doctors before you sign. 
 
Things to know before deciding to take part in a research study: 
 
 
The main goal of a research study is to learn things to help patients in the future. 
 
The main goal of regular medical care is to help each patient. 
 
The decision to join or not join the research study will not cause you to lose any medical benefits. If 
you decide not to take part in this study, your doctor will continue to treat you. 
 
Parts of this study may involve standard medical care. Standard care is the treatment normally 
given for a certain condition or illness. 
 
Other parts of this study may involve experimental (investigational) drugs or procedures that are 
being tested for a certain condition or illness. An investigational drug is one that has not been 
approved by the US Food and Drug Administration (FDA). The investigational drug that is being 
used in this study is known as GT0918 (proxalutamide). 
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 
After reading the consent form and having a discussion with the research staff, you should know 
which parts of the study are experimental and which are standard medical care. 
 
Your medical records may become part of the research record. If that happens, your medical 
records may be looked at and/or copied by the sponsor of this study and government agencies or 
other groups associated with the study. 
 
Your medical insurance may be billed for any standard medical care you receive during the 
research study. If your insurance company is billed, then it may have access to the research records. 
Insurance companies may not pay for treatment that is part of a research study. Taking part in a 
research study may or may not affect your current or future insurance coverage. 
 
PURPOSE OF THE STUDY 
You are being asked to take part in this research study as your prostate cancer has not responded to or 
progressed on hormonal therapy abiraterone or enzalutamide. 
 
Prostate cancer requires testosterone to grow and spread. Goal of the treatment of prostate cancer is to 
remove the source of male hormones, either surgically (castration) or by giving drugs to both stop the 
production of male hormones and to block the effect of male hormones on the prostate cancer. 
 
The current approved drugs, XTANDI® (enzalutamide), or Zytiga® (abiraterone) can block the male 
hormone activity; however, the medication does not work for everyone or for all time. Now if your disease 
gets worse or you have serious side effects from either of these drugs, you may be qualified for this study.  
 
There are 2 parts (stages) to this research study and first part of study has finished. This is the second part of 
the expanded/Phase 2 study. It is to learn if the drug is safe in more patients who are administered the drug 
and to find the best dose to take with the least side effects.  
 
There are 60 patients who will participate in this study and will be randomized (like the flip of a coin) to 
orally receive study drug at 400 mg, or 500 mg daily. If you are enrolled into the current study, you will be 
asked to take GT0918 tablets every day by mouth on an empty stomach (or 2-3 hours after a meal) for up to 
6 months, have blood drawn, and safety tests performed at multiple times through-out your participation in 
this study.  All participants will be evaluated by the study doctor and the doctor’s staff for side effects.  
 
While taking the study drug, if your study doctor sees that you are receiving clinical benefits, you may 
continue on the study after you finish the first 6 months of study drug. 
 
PATIENT RESPONSIBILITIES 
During the study, you will have the following responsibilities: 
 
 
Report to your study doctor or study nurse immediately if you feel allergic to the study drug, 
fatigue/lethargy, dizziness, pain or edema in hands and feet, loss of appetite, and symptoms that 
have significant impact on your daily activities. If the study drug dose is deemed too high for you, 
your doctor may ask you to take a couple of days off or/and reduce the dose of study drug. 
 
Attend all scheduled visits. 
 
Take the study drug as directed. 
 
Return any unused study drug and containers as instructed by the study staff. 
 
Follow the study doctor’s instructions about whether you may continue to take your regular 
prescribed medications or over-the-counter medicines during the study period. 
 
Tell the study doctor all drugs you are taking, any changes to your current medications, illnesses or 
injuries, unexpected or troublesome side effects, or problems that are not mentioned above. 
 
Tell the study doctor if you plan to have an elective surgery or any other medical treatment or 
procedure. 
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 
You should continue to make regular visits to your primary doctor or any other special doctors 
whom you were seeing before starting the study, since being in the study does not replace regular 
medical care. 
 
Make sure that the study drug is kept out of the reach of children and people who have a limited 
capacity to read or understand. You are the only person who should take the study drug. Contact the 
study doctor if you find you have any questions about the study after you sign this form. 
 
You and/or your partner must use a reliable form of contraception during the study and for at least 
3 months after you are off from the study drug. If your partner becomes pregnant while you are in 
the study, be sure to tell the study doctor as soon as possible. 
 
PROCEDURES 
The doctor in charge of this study or a member of the study staff will have discussions with you regarding 
the requirements for participation in this study. In order to participate in this expanded/phase II study, one 
of the selection criteria is prior therapy of abiraterone or enzalutamide, not both. As a subject in this study, 
you will receive active study drug. You should take the study drug by mouth on an empty stomach (or 2-3 
hours after a meal). 
 
Expanded / Phase II Study 
 
Screening 
 
You will first visit the clinic and sign an Informed Consent form before you complete any study related 
procedures.  
 
After signing the Informed Consent Form, the doctor or staff will ask you questions about your medical and 
surgical history, how you are doing, and any medications you are taking.   You should have a computed 
tomography (CT) or magnetic resonance imaging (MRI), or/and bone scan, to assess your disease. If the 
previous assessment was more than 42 days ago, you may be asked to have another CT or MRI or bone 
scan. All scans and tests must be performed within 6 weeks before starting study drug.  
 
You will have the following study procedures completed: 
 
 
vital signs taken (heart rate, breath rate, blood pressure and body temperature) and height taken, 
 
a complete physical exam performed, 
 
your physical capability (ECOG) assessed, 
 
blood and urine taken for laboratory tests, and  
 
an ECG will be performed. 
 
Week 1, Day 1 (Baseline) 
You will visit the clinic. The study doctor and staff will confirm that you remain eligible to participate in 
this study. The doctor and study staff will ask you questions about any changes in your medical and surgical 
history, medications you are taking , how are you are doing and any side effects you may have since your 
last screening visit. Your physical capability (ECOG) will be assessed, vital signs taken, a brief physical 
exam performed, blood taken (about 4.5 to 6.5 tablespoons) for laboratory and exploratory marker tests 
(about 3 tablespoons blood) to be drawn, and a urine sample will be collected. The ECG performed within 
30 minutes of taking study drug. Instruction of what and how to take study drug will be given to you in the 
clinic and you will be given a supply of 14 days of study drug. You are required to take the study drug on the 
same time every day.  You will be discharged from the clinic after all procedures are completed. 
 
Day 15 (Week 3) 
You will visit the clinic.  The study doctor and staff will ask you questions about medications you are taking 
how you are doing, and any side effects since the previous visit. You will also have vital signs taken, a brief 
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physical exam, and your physical capability (ECOG) assessed. Additionally, you will bring any unused 
study drugs and empty box of study drug when you visit the doctor office. The study staff will count your 
pills and check your diary to ensure that you are taking study drug daily and do so at the same time each day. 
You will be given a supply of 2 weeks (for Day 15) of study drug to take home. You will be discharged from 
the clinic after all procedures are completed. 
 
Day 29, also known as Cycle 2 Day 1 
You will visit the clinic.  The study doctor and staff will ask you questions about medications you are 
taking, how you are doing and any side effects since the previous visit.  You will also have vital signs taken, 
a complete physical exam performed, your physical capability (ECOG) assessed, blood taken (about 3 to 5 
tablespoons) for laboratory tests, and a urine sample will be collected for testing. A single ECG will be 
performed.  Study drug of 28 days of supply then will be given to you in the clinic following all procedures 
are complete.  You will be discharged from the clinic after all procedures are completed.   
 
Cycles 3-6, (Day 57, 85, 113, and 141) 
You will visit the clinic if qualified to continue in subsequent cycles.  The study doctor and staff will ask 
you questions about medications you are taking how you are doing, and any side effects since the previous 
visit. 
 
You will also have part or all of the following tests performed: 
 
 
vital signs taken 
 
a physical exam performed  
 
physical capability (ECOG) assessed 
 
disease status assessed (will be measured by radiologic methods (CT and/or MRI) on Day 85 
 
blood taken for laboratory tests, hormone test at Cycle 4 (Day 92), exploratory marker tests every 3 
month and a urine sample collected for testing 
 
single ECG performed monthly  with repeat ECGs if abnormal readings seen 
 
Additionally, the study staff will count your unused pills and/or empty boxes to ensure that you comply 
with the protocol.  Study drug of 28 days then will be given to you. You will be discharged from the clinic 
after all procedures are completed. 
 
Additional Study- (Additional 24 Months After Cycle 6 Day 28) 
If you have completed all 6 cycles of the study, your disease is not worsening, and the study doctor and 
sponsor agree that you are likely to have continued benefit from participation in the study, you will have the 
option to continue in the study until either you show signs of disease worsening, the doctor determines you 
need to end the study, or you have completed the 24 months of the additional study.  You will be required to 
visit the clinic monthly.  The study doctor will ask you questions about medications you are taking, how are 
you doing and any side effects since the previous visit.  You will also have vital signs taken, a brief physical 
exam for all visits except for the very last visit on Cycle 30 Day 28 at which time a complete physical exam 
will be performed, your physical capability (ECOG) assessed, blood taken (about 3 to 5 tablespoons) for 
laboratory tests and exploratory marker tests (every 3 months, 84 +/- 7 days) and a urine sample will be 
collected for testing. Disease status will be assessed (measured by radiologic methods [CT and/or MRI]) 
every 3 months (84 +/- 7 days). The study staff will count your pills to ensure that you comply with the 
protocol.  After all study procedures are completed, you will be given a supply of study drug to last until 
your next visit (unless this is the last visit of the extension study, 24 months after Cycle 6 Day 28). You will 
be discharged from the clinic after all procedures are completed.  
 
End of Study or Early Termination 
You will visit the clinic after your last dose of study drug, and the study doctor and staff will ask you 
questions about medications you are taking, how you are doing, and any side effects you may experience 
since the previous visit. You will also have vital signs taken, a brief physical examination performed, and 
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your physical capability (ECOG) assessed. The study staff will count your pills if not already completed to 
ensure that you comply with the protocol. You will have blood drawn (about 2 to 3 tablespoons) for 
hormone and exploratory marker testing. You will be discharged from the clinic after all procedures are 
completed. 
 
If you are unable to attend the End of Study visit in person, a phone call will be made to ask you questions 
about medications you are taking and any side effects since the previous visit.  You may also be asked 
questions to assess your physical capability (ECOG). 
 
Safety Follow-up 
 
You will visit the clinic or be called 30 days after your last dose to check any experimental drug-related side 
effect you may have.  
 
Unscheduled Visits 
Your study doctor may at his/her discretion arrange for you to have an unscheduled visit, especially in the 
case of disease conditions or/and side effects that require follow-up or considered by study doctor.  
 
RISKS AND DISCOMFORTS 
There may be risks to you if you participate in this study.  
 
Study Procedure Risks 
 
Blood Tests 
For many subjects, needle punctures for blood draws do not cause any serious problems. Some side effects 
that may be seen are bleeding, bruising, discomfort, infections, dizziness, and/or pain at the needle site. 
 
Imaging Tests 
Some imaging techniques that may be used to follow your cancer include CT, MRI, positron emission 
tomography, and x-rays. These tests will expose you to a moderate to high doses of ionizing radiation. 
Some people may also get claustrophobic (feel closed in) from being in the imaging machine, which is 
sometimes in the shape of a tube. 
 
Potential Risks and Discomforts Associated with GT0918 
This is an Expanded /Phase 2 study is to find best dosing with less side effects in more number of study 
subjects. Thus, there may be side effects that are not known at this time. 
 
From limited subjects in clinical study that occurred with this study drug and common in patients with 
cancer, you may expect or experience any of the following adverse events (side effects) during your 
treatment, possibly, fatigue,  lethargy, headache, nausea, vomiting, dizziness, loss of appetite, weight loss, 
diarrhea, hot flushes, hypercholesterolemia, hyperglycemia, hypertriglyceridemia, peripheral edema, 
constipation, back pain, anemia, pain in extremities, arthralgia, elevated creatine kinase, transaminase 
elevation, liver injury, hepatic failure, hepatic cirrhosis. Should any of these side effects occur, you should 
immediately notify your doctor or/and study staff. 
 
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As a study subject, you should not get your sexual partner pregnant while taking the study drug. The effects 
of the study drug on sperm, embryos, or fetuses are not known. If you think that your partner may have 
gotten pregnant during the study, you must tell your study doctor immediately. 
 
Other Risks 
 
The study drug is a CYP 3A4 inhibitor and has shown some level of drug interactions with CYP 3A4 
components in some patients during this trial. For example, several patients on simvastatin 40 mg or higher 
daily resulted in elevated lab results of ALT, AST, CK, muscle pain, rhabdomyolysis (damage to skeletal 
muscle), etc.  Please discuss with your doctor the list of potential interactions  
 
Your condition may not get better or may get worse during this study. 
 
Only you should take the study drug. It must be kept out of the reach of children or anyone else who may not 
be able to read or understand the label. 
 
NEW INFORMATION 
You will be told about any new information that might change your decision to be in this study in a timely 
manner. You may be asked to sign a new consent form if this occurs. 
 
BENEFITS 
The benefits are not known yet. It cannot be promised that you will receive any medical benefits from being 
in this study. Information from this research may help people with mCRPC in the future. 
 
COSTS 
Suzhou Kintor Pharmaceutical, Inc. will provide the study drug free of charge during this study. Tests and 
procedures that are out of standard of care and done only for the study will not be billed to you or your 
insurance company. 
 
You or your insurance company may be billed for any standard medical care given during this research 
study. 
 
You may want to talk with your insurance company about its payment policy for standard medical care 
given during a research study. If your insurance company does not pay, you may be billed for those charges. 
 
You might have unexpected expenses from being in this study. Ask your study doctor to discuss the costs 
that will or will not be covered by the sponsor. This discussion should include who will pay the costs of 
treating possible side effects. 
 
PAYMENT FOR PARTICIPATION 
You will not be paid for being in this study. 
 
ALTERNATIVE TREATMENT 
If you decide not to enter this study, there are other treatment choices available to you.  Please ask your 
study doctor to discuss these alternatives with you. You do not need to be in this study to receive treatment 
for your condition. 
 
AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH PURPOSES 
 
What information may be used and given to others? 
The study doctor will get your demographic and medical information. For example: 
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• 
Past and present medical records 
• 
Research records 
• 
Records about phone calls made as part of this research 
• 
Records about your study visits 
 
Study records and source documents must be preserved for at least 15 years after the completion 
or discontinuation of/withdrawal from the study or 2 years after the last approval of a marketing application 
in an ICH region, whichever is the longer time period. 
 
Who may use and give out information about you? 
The study doctor and the study staff 
 
Who might get this information? 
The sponsor of this research will get unidentified medical information under HIPAA. "Sponsor" means any 
persons or companies that are: 
• 
working for or with the sponsor, or employee (such as study team) of the sponsor. 
 
Information may be given to: 
• 
The US FDA, 
• 
Department of Health and Human Services (DHHS) agencies, 
• 
Governmental agencies to whom certain diseases (reportable diseases) must be reported, and 
• 
Institutional Review Board. 
 
Why will this information be used and/or given to others? 
• 
to do the research, 
• 
to study the results, and 
• 
to see if the research was done right. 
 
If the results of this study are used or made public, information that identifies you will not be used. 
 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
 
May I review or copy my information? 
Yes, but only after the research is over. 
 
May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically. 
 
You may withdraw or take away your permission to use and disclose your health information at any time. 
You do this by sending written notice to the study doctor. If you withdraw your permission, you will not be 
able to stay in this study or join the study again at a later time. 
 
When you withdraw your permission, no new health information will be gathered after that date. 
Information that has already been gathered may still be used and given to others. 
 
Is my health information protected after it has been given to others? 
There is a risk that your information will be given to others without your permission. 
 
Confidentiality 
Information from this study will be given to the sponsor. “Sponsor” includes any persons or companies that 
are contracted by the sponsor to have access to the research information during and after the study. 
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The information will also be given to the US FDA. Medical records which identify you and the consent 
form signed by you will be looked at and/or copied for research or regulatory purposes by: 
 
• 
Suzhou Kintor Pharmaceutical, Inc., the sponsor, 
• 
Syneos Health an agent for the sponsor, 
 
and may be looked at and/or copied for research or regulatory purposes by: 
 
• 
the FDA, 
• 
DHHS agencies, 
• 
governmental agencies in other countries, and 
• 
Institutional Review Board. 
 
Absolute confidentiality cannot be guaranteed because of the need to give information to these parties. The 
results of this research study may be presented at meetings or in publications. Your identity will not be 
disclosed in those presentations. 
 
COMPENSATION FOR INJURY 
If you are injured or get sick as a result of being in this study, call the study doctor immediately. The study 
doctor will provide emergency medical treatment. Your insurance will be billed for this treatment. The 
sponsor will pay any charges that your insurance does not cover. No other payment is routinely available 
from the study doctor or sponsor. 
 
VOLUNTARY PARTICIPATION AND WITHDRAWAL 
Your participation in this study is voluntary. You may decide not to participate, or you may leave the study 
at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise 
entitled. 
 
Your participation in this study may be stopped at any time by the study doctor or the sponsor without your 
consent for any reason, including: 
 
• 
discovery that you do not meet the study requirements 
• 
if it is in your best interest 
• 
if you do not consent to continue in the study after being told of changes in the research that may 
affect you 
• 
any change in your medical condition that might make continuation in the study harmful to you  
• 
your failure to follow the study doctor’s instructions 
• 
Cancellation of the study 
 
If you leave the study before the planned final visit, you may be asked by the study doctor to have some 
tests or procedures done so that you leave the study safely. 
 
SOURCE OF FUNDING FOR THE STUDY 
The sponsor, Suzhou Kintor Pharmaceutical, Inc., will pay for this research study. 
 
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QUESTIONS 
Contact [name] at [number(s)] for any of the following reasons: 
 
• 
if you have any questions about your participation in this study, 
• 
if you feel you have had a research-related injury or a reaction to the study drug, or 
• 
if you have questions, concerns or complaints about the research. 
 
If you have questions about your rights as a research subject or if you have questions, concerns, or 
complaints about the research, you may contact: 
 
 
Western Institutional Review Board® (WIRB®) 
 
1019 39th Avenue SE Suite 120 
 
Puyallup, Washington  98374-2115 
 
Telephone:  1-800-562-4789 or 360-252-2500 
 
E-mail: Help@wirb.com 
 
An Institutional Review Board (IRB) is a group of people who independently review research. 
 
IRB will not be able to answer some study-specific questions, such as questions about appointment times. 
However, you may contact IRB if the research staff cannot be reached or if you wish to talk to someone 
other than the research staff. 
 
Do not sign this consent form unless you have had a chance to ask questions and have gotten satisfactory 
answers. 
 
If you agree to be in this study, you will receive a signed and dated copy of this consent form for your 
records. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time. 
 
REQUEST FOR AUTHORIZATION TO STORE BLOOD SAMPLES FOR FUTURE TESTING 
 
The study sponsor would like to store your blood samples for future testing. The future testing would be 
related to the purpose of the study protocol- to test the safety of the study drug and to get a better 
understanding of prostate cancer. Your samples will not be labeled with your name or other directly 
identifying information. Your samples will have a code instead. The list that matches the code with your 
name will be stored separately from your samples. 
 
You have the option to choose not to allow your samples to be utilized for future testing. You may withdraw 
your consent for the use of your blood samples in future testing at any time during or after the study by 
contacting the study doctor. 
 
Please INITIAL one response below: 
 
 
 I allow that my samples can be used for future testing. 
 
 
 I request that my samples not be used for future testing. 
 
CONSENT 
I have read this consent form (or it has been read to me). All my questions about the study and my part in it 
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have been answered. I freely consent to be in this research study. 
 
I authorize the release of my medical and research records for the purpose of this study. By signing this 
consent form, I have not given up any of my legal rights. 
 
 
 
 
Subject Name (printed) 
 
 
 
 
 
 
Signature of Subject 
 
Date 
 
INVESTIGATOR: I,  ______________________________ , acknowledge that the purpose of this 
research study, the procedures required, the potential risks and benefits associated with participating in this 
study, and alternatives to participation in this study and the potential risks and benefits associated with these 
alternatives have been discussed with this individual. All of the participant's questions have been answered 
and he has voluntarily agreed to participate. A signed and dated copy of this document will be given to the 
participant. 
 
 
 
 
 
 
Printed Name of Investigator 
Date 
 
 
 
 
 
 
Signature of Investigator 
Date 
 
 
 
 
 
 
Printed Name of Person Conducting Informed Consent 
Date 
Discussion (if different from Investigator above) 
 
 
 
 
 
 
Signature of Person Conducting Informed Consent 
Date 
Discussion (if different from Investigator above) 
 
Authorization to Use and Disclose Personal Health Information 
 
The United States government has issued a Privacy Rule to protect the privacy rights of patients. This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 
The Privacy Rule is designed to protect the confidentiality of your personal health information. The 
document you are reading, called an "Authorization," describes your rights and explains how your health 
information will be used and disclosed (shared). 
 
Under federal privacy regulations, you have the right to determine who has access to your personal health 
information (called "protected health information" or "PHI"). PHI collected in this study may include your 
medical history, the results of physical exams, laboratory tests, x-ray exams, and other diagnostic and 
treatment procedures as described in the "Procedures" section of this consent form as well as basic 
demographic (age, gender, ethnicity) information. 
 
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By signing this form, you allow the study doctor and/or study staff to disclose your information to the 
sponsor, Suzhou Kintor Pharmaceutical, Inc., and the sponsor's representative(s). The data sent by the study 
doctor and/or study staff to the sponsor do not include your name, address, or social security number. 
 
Your information may be reviewed and/or copied by the sponsor or sponsor's representative(s), FDA, IRB, 
or by other regulatory agencies in this country or in other countries to ensure the quality of the study or for 
other uses allowed by law. 
 
Federal and state laws require the study doctor and/or study staff to protect the privacy of your information. 
However, absolute confidentiality cannot be guaranteed because of the need to disclose information as 
described above. After the study doctor and/or study staff shares your information with the sponsor or 
others, the law may no longer protect the privacy of the information, and it may be further disclosed. 
 
You have the right to see and copy your records related to the study for as long as the study doctor has this 
information in his or her possession. However, by signing this form you agree that you might not be able to 
review some of your records related to the study until after the study has been completed, at which time 
your right of access will be restored. 
 
This Authorization does not have an expiration date. If you do not revoke (cancel) this Authorization, then 
it will remain in effect indefinitely. 
 
You can revoke (cancel) this Authorization at any time by giving written notice to the study doctor at the 
address listed on page 1. If you revoke this Authorization, then you will no longer be able to participate in 
the study, and no new information will be collected for study purposes unless the information concerns an 
adverse event (a bad effect) related to the study. If an adverse event occurs, your entire medical record may 
be reviewed. All the information that has been collected prior to revoking the Authorization and any new 
information about a side effect related to the study may still be used and disclose to the above-mentioned 
parties. 
 
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends. 
 
If you do not sign this Authorization, you cannot participate in this research study or receive study-related 
treatment. If you withdraw this Authorization in the future, you will no longer be able to participate in this 
study. Your decision to withdraw your Authorization or not to participate will not involve any penalty or 
loss of access to treatment or other benefits to which you are entitled. 
 
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AUTHORIZATION 
I authorize the release of my medical records and personal health information related to this study to the 
sponsor and its representatives, the Western Institutional Review Board, the FDA, and other regulatory 
agencies as described above. I have been told that I will receive a signed and dated copy of this 
Authorization for my records. 
 
 
 
 
Subject Name (printed) 
 
 
 
 
 
 
Signature of Subject 
Date 
 
 
 
 
Name of Study Staff Member Administering Consent 
(printed) 
 
 
 
 
 
 
Signature of Study Staff Member Administering Consent  
Date 
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