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

August 27, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai Jiaotong University School of Medicine, Renji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-5041
Drug: 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.
Active Comparator: Docetaxel Injection + Prednisone Acetate Tablets group
Drug: Docetaxel injection
Docetaxel injection.
Drug: Prednisone Acetate Tablets
Prednisone Acetate tablets.
Active Comparator: Abiraterone Acetate Tablets + Prednisone Acetate Tablets group
Drug: Prednisone Acetate Tablets
Prednisone Acetate tablets.
Drug: Abiraterone acetate tablets
Abiraterone Acetate tablets.
Active Comparator: Enzalutamide Soft Capsules group
Drug: Enzalutamide Soft Capsules
Enzalutamide Soft capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose (MTD)
Time Frame: Up to 28 days
Up to 28 days
Dose-limiting toxicity (DLT)
Time Frame: Up to 28 days
Up to 28 days
Recommended Phase 2 Dose (RP2D) of HRS-5041
Time Frame: Up to 28 days
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 24 months
24 months
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
Time Frame: From the time of consent at screening until 30 days after the subject discontinues study treatment, up to 2 years
From the time of consent at screening until 30 days after the subject discontinues study treatment, up to 2 years
Pharmacokinetics - Area under the plasma concentration time curve (AUC)
Time Frame: 12 weeks
12 weeks
Pharmacokinetics - Maximum plasma concentration (Cmax)
Time Frame: 12 weeks
12 weeks
Pharmacokinetics - Time to Cmax (Tmax)
Time Frame: 12 weeks
12 weeks
Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
Time Frame: 24 months
24 months
PSA Progression Free Survival (PFS)
Time Frame: 24 months
24 months
Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Time Frame: 24 months
24 months
Radiographic progression free survival (rPFS)
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-5041-101

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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