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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Able and willing to provide a written informed consent.
• Age 18-80 years old, gender unlimited.
• The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \
• Predicted survival ≥12 weeks.
• Histological or cytological confirmed adenocarcinoma of the prostate.
• Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy.
Locations
Other Locations
China
Shanghai Jiaotong University School of Medicine, Renji Hospital
RECRUITING
Shanghai
Contact Information
Primary
Suyu Fan
suyu.fan@hengrui.com
+0518-81220121
Time Frame
Start Date: 2023-08-03
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 100
Treatments
Experimental: HRS-5041
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.