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Clinical Trials in China / NCT05942001
Recruiting Phase 1

Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT05942001 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd
Phase
Phase 1
Started
2023-08-03
Last updated
2026-08-31

Condition(s) studied

Advanced Prostate Cancer

Investigational drug(s) / intervention(s)

HRS-5041 →Docetaxel injection →Abiraterone acetate tablets →Prednisone Acetate Tablets →Enzalutamide Soft Capsules →

HRS-5041: HRS-5041 was given oral administration, qd, at a 28-day cycle. Patients may continue to use HRS-5041 until disease progression or unacceptable toxicity occurs.

Docetaxel injection: Docetaxel injection.

Abiraterone acetate tablets: Abiraterone Acetate tablets.

Prednisone Acetate Tablets: Prednisone Acetate tablets.

Enzalutamide Soft Capsules: Enzalutamide Soft capsules.

Study summary

The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.

Eligibility

Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Able and willing to provide a written informed consent. 2. Age 18-80 years old, gender unlimited. 3. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \~ 1. 4. Predicted survival ≥12 weeks. 5. Histological or cytological confirmed adenocarcinoma of the prostate. 6. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy. Exclusion Criteria: 1. Prior treatment with an androgen receptor (AR) degrader. 2. Plan to receive any other antitumor therapy during this trial. 3. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study. 4. Patients with known brain metastases. 5. Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.

Primary outcome measure(s)

  • Dose-limiting toxicity (DLT) — Up to 28 days
  • Maximum tolerated dose (MTD) — Up to 28 days
  • Recommended Phase 2 Dose (RP2D) of HRS-5041 — Up to 28 days

Trial sites (1)

FacilityCityRegionStatus
Shanghai Jiaotong University School of Medicine, Renji Hospital Shanghai Shanghai Municipality Recruiting

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes Starting soon
A Phase I Study of HRS-7172 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications Recruiting

Other trials for the same condition

Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer Recruiting
DEC003M in Prostate Cancer Recruiting
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05942001 on ClinicalTrials.gov ↗ ← All trials in China