A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating the efficacy and safety of HC-1119 soft capsules versus placebo in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for docetaxel treatment.

Timeline

Start

2019-04-12

Primary completion

2025-09

Completion

2025-09

Publications

• Wu J, Li X, Gu C, Hua L, Liu R, Li J, Qiu M, Guo J, Dong H, Ji Z, Xie L, Zhu S, Zhang X, Chen P, Jiang S, Sun Z, Xu D, Chen H, Shi B, Wang Y, Pu J, Perabo F, Chen Y, Ye D. Deutenzalutamide, a novel androgen receptor inhibitor, after progression on docetaxel and abiraterone in metastatic castration-resistant prostate cancer: results from the randomized phase III HC-1119-04 trial. Signal Transduct Target Ther. 2026 Apr 13;11(1):131. doi: 10.1038/s41392-026-02618-3.

Drugs

Indications