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A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer

StatusRecruiting
PhasePhase 1/2
Started2024-09-25
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2026 → Dec 2026
See other at-risk trials from Jiangsu HengRui Medicine Co., Ltd.

Amendment history

2026-09-18
Primary completion pushed: 2026-06 → 2026-12
Interventions modified
2026-06-07
Study Status, Arms and Interventions, Outcome Measures v6
Trial arms changed: 4 → 7
InterventionsAbiraterone Acetate tablets（II） (Drug), Docetaxel Injection (Drug), HRS-1167 tablets (Drug), HRS-5041 tablets (Drug), Prednisone Acetate…→Abiraterone Acetate tablets（II） (Drug), Darolutamide Tablets (Drug), Docetaxel Injection (Drug), HRS-1167 tablets (Drug), HRS-5041 tablets…
Secondary endpoints11 to 12 entries
Blood concentrations of HRS-6208 (Phase Ib)
2025-12-26
Study Status v5
Re-verified, no change to tracked fields
2025-11-16
Study Status, Outcome Measures, Contacts/Locations v4
Primary completion date2025-09-01→2026-06
Completion date2026-12-31→2027-06
Start date2024-09-06→2024-09-25
Secondary endpoints10 to 11 entries
Blood concentrations of HRS-5041(Phase Ib) Blood concentrations of HRS-1167(Phase Ib) Blood concentrations of SHR2554(Phase Ib) Blood concentrations of Abiraterone (Phase Ib)
Study sitescontacts updated at 1 of 2 sites
2025-03-14
Study Status v3
Re-verified, no change to tracked fields
Show 2 earlier versions
2024-10-21
Study Status, Contacts/Locations v2
Study sitesdetails revised at 1 of 2 sites
2024-09-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09-01→confirmed 2024-09-06
Study sitesdetails revised at 2 of 2 sites
2024-08-21
Original filing
The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.
Trial Details
NCT Number NCT06568094
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Prostate Cancer
Enrollment 100 participants
Start Date 2024-09-25
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-17