Clinical Trial: NCT05942001
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
| Information Provided By: | Jiangsu HengRui Medicine Co., Ltd. |
| Last Update Posted: | 2026-08-31 |
Study Overview
Brief 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
Conditions
Advanced Prostate Cancer
Intervention / Treatment
- Drug: HRS-5041
- Drug: Docetaxel injection
- Drug: Abiraterone acetate tablets
- Drug: Prednisone Acetate Tablets
- Drug: Enzalutamide Soft Capsules
Other Study ID Numbers
- HRS-5041-101
Start Date (Actual)
2023-08-03
Primary Completion Date (Estimated)
2026-09
Study Completion Date (Estimated)
2026-09
Enrollment (Estimated)
100
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
| Information Provided By: | Jiangsu HengRui Medicine Co., Ltd. |
| Last Update Posted: | 2026-08-31 |
Study Overview
Brief 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
Conditions
Advanced Prostate Cancer
Intervention / Treatment
- Drug: HRS-5041
- Drug: Docetaxel injection
- Drug: Abiraterone acetate tablets
- Drug: Prednisone Acetate Tablets
- Drug: Enzalutamide Soft Capsules
Other Study ID Numbers
- HRS-5041-101
Start Date (Actual)
2023-08-03
Primary Completion Date (Estimated)
2026-09
Study Completion Date (Estimated)
2026-09
Enrollment (Estimated)
100
Study Type
Interventional
Phase
Phase 1