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Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
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
Conditions
Interventions
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.
Locations (1)
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China