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RECRUITING
NCT05942001
PHASE1

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

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-08-03

Completion Date

2026-09

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

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.

DRUG

Docetaxel injection

Docetaxel injection.

DRUG

Abiraterone acetate tablets

Abiraterone Acetate tablets.

DRUG

Prednisone Acetate Tablets

Prednisone Acetate tablets.

DRUG

Enzalutamide Soft Capsules

Enzalutamide Soft capsules.

Locations (1)

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China