Trials / Recruiting
RecruitingNCT05942001
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-08-03
- Primary completion
- 2025-08-31
- Completion
- 2025-08-31
- First posted
- 2023-07-12
- Last updated
- 2025-02-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05942001. Inclusion in this directory is not an endorsement.