Actively Recruiting
Study of QLC5508 andor QLH12016 Combined with Other Anti-tumor Drugs in Men With Advanced Prostate Cancer
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-06-02
212
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor effects of QLC5508 and QLH12016 combined with other anti-tumor therapies in men with advanced prostate cancer. This open-label, multicenter Phase IbII trial aims to find the best dose and explore how well these combinations work, especially in patients with metastatic disease and castrate-resistant prostate cancer. The study has two stages Phase Ib involves carefully increasing doses of these drugs to determine the recommended Phase II dose, while Phase II focuses on assessing their therapeutic effects at that dose. Participants may receive QLC5508 by injection, and oral medications including abiraterone, enzalutamide, and QLH12016 in various combinations as specified in the protocol. Participants will be evaluated throughout the study with blood tests for genetic mutation analysis, monitoring for side effects, and assessments of prostate-specific antigen PSA response and tumor response over about one year. Safety, tolerability, and pharmacokinetics will be closely observed during Phase Ib, while Phase II will measure effectiveness through PSA50 response and objective response rate. The study is expected to continue until late 2027.
CONDITIONS
Brief Title
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
Research Team
X
Xin Yao, PHD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
