A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer

A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of HS-20093 or SHR2554 Tablets in Combination With Novel Hormonal Agents in Participants With Metastatic Prostate Cancer

This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: HS-20093 for Injection; Drug: SHR3680 Tablet; Drug: Abiraterone Tablet; Drug: SHR2554 Tablet; Drug: Enzalutamide Tablet; Drug: Darotamine Capsule

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wenliang Wang; Phone Number: +86-0518-82342973; Email: wenliang.wang@hengrui.com
• Study Contact Backup: Name: Qi Zhang; Phone Number: +86-021-60453139; Email: qi.zhang@hengrui.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Principal Investigator: Hongqian Guo
      • Contact: Hongqian Guo; Phone Number: 025-68182869; Email: gymwpi@126.com
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Principal Investigator: Xin Yao
      • Contact: Xin Yao; Phone Number: 2131 022-23340123; Email: yaoxin@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily participate in this clinical study, understand the research procedures, and are able to provide written informed consent.
2. Aged 18 to 80 years (inclusive), male.
3. ECOG performance status of 0 or 1.
4. Expected survival time ≥12 weeks.
5. Histologically or cytologically confirmed prostate adenocarcinoma, with no features of neuroendocrine carcinoma or small cell carcinoma.
6. Able to provide sufficient tumor tissue samples for retrospective genetic testing.
7. Ongoing Androgen Deprivation Therapy (ADT) throughout the study period, i.e., continuous treatment with a GnRH agonist or antagonist (chemical castration) or prior bilateral orchiectomy (surgical castration).
8. PSA level ≥1 ng/ml at screening.
9. Adequate organ function levels at baseline assessment.
10. Male participants with female partners of childbearing potential must agree to refrain from sperm donation and use effective contraception from the time of signing the informed consent form until 4.5 months after the last dose of HS-20093 or 3 months after the last dose of other study treatments, whichever is later.

Exclusion Criteria:

1. Known hypersensitivity or intolerance to the investigational drug(s) or their excipients.
2. Adverse events from prior anti-tumor therapy have not recovered to Grade ≤1 as per CTCAE v5.0.
3. Administration of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days prior to enrollment.
4. Administration of herbal medicines known to have anti-prostate cancer or PSA-lowering effects within 14 days prior to enrollment.
5. Major surgery within 28 days prior to enrollment; palliative radiotherapy within 14 days prior to enrollment; or traumatic minor surgery within 7 days prior to enrollment.
6. Pathological fractures in critical locations, spinal cord compression, etc., within the recent 6 months.
7. Non-healing wounds, untreated fractures, or severe bone damage due to metastatic disease.
8. Poorly controlled tumor-related pain.
9. Dysphagia or other conditions significantly affecting drug absorption.
10. Known central nervous system metastases or primary brain tumors.
11. Significant pericardial, pleural, or peritoneal effusion requiring intervention.
12. Severe cardiovascular or cerebrovascular diseases.
13. Moderate to severe pulmonary disease significantly affecting respiratory function.
14. Poorly controlled diabetes.
15. Serious active infections within 14 days prior to enrollment.
16. Active Hepatitis B, Hepatitis C, HIV, or immunodeficiency diseases.
17. History of other malignancies within 5 years prior to enrollment.
18. Any other condition deemed by the investigator to potentially affect the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 Group	Drug: HS-20093 for Injection; HS-20093 for injection.; Drug: SHR3680 Tablet; SHR3680 tablet.; Drug: Abiraterone Tablet; Abiraterone tablet.
Experimental: Cohort 2 Group	Drug: SHR3680 Tablet; SHR3680 tablet.; Drug: SHR2554 Tablet; SHR2554 tablet.; Drug: Enzalutamide Tablet; Enzalutamide tablet.; Drug: Darotamine Capsule; Darotamine capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate.	6 months.
Cohort 2: Prostate Specific Antigen (PSA) response rate.	About 2 years.
Cohort 2: Adverse events (AEs).	About 2 years.
Cohort 2: Dose-limiting toxicity (DLT).	About 28 days.

Secondary Outcome Measures

Outcome Measure	Time Frame
Radiographic Progression-Free Survival (rPFS).	About 2 years.
Time to Prostate Specific Antigen (PSA) progression.	About 2 years.
Time to Next Symptomatic Skeletal Event (SSE).	About 2 years.
Time to Next Antineoplastic Therapy (TTNT).	About 2 years.
Objective response rate (ORR).	About 2 years.
Cohort 1: Adverse events (AEs).	About 2 years.
Disease control rate (DCR).	About 2 years.
Duration of response (DoR).	About 2 years.
Overall Survival (OS).	About 2 years.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; abiraterone; enzalutamide
• Other Study ID Numbers: SHR3680-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No