Overview

Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.

Status:
NOT_YET_RECRUITING

Trial end date:
2027-03-31

Target enrollment:

Participant gender:

Summary

This study is a single-arm, multicenter, phase II exploratory trial. The purpose is to explore the efficacy and safety of Darxicilib in combination with Abiraterone Acetate for the treatment of subjects with metastatic castration-resistant prostate cancer.The main questions it aims to answer are: ·PSA50 response rate at the end of week 12 Participants will: * Darxicilib: 125mg per tablet, oral administration, once daily for 21 consecutive days followed by a 7-day break. * Abiraterone Acetate tablets (II): 300mg per dose, oral administration, once daily for a 28-day cycle. * Prednisone: 5mg per tablet, oral administration, twice daily.

Phase:

PHASE2

Details

Lead Sponsor:

Qilu Hospital of Shandong University

Collaborator:

Jiangsu HengRui Medicine Co., Ltd.

Treatments:

Abiraterone Acetate
Androgen Antagonists
Prednisone