Actively Recruiting
Safety and Effects of Oral FX-111 in Adult Men with Advanced Metastatic Castration-Resistant Prostate Cancer
Led by Flare Therapeutics Inc. · Updated on 2026-08-04
60
Participants Needed
10
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of FX-111 in adult men with metastatic castration-resistant prostate cancer mCRPC. This phase 1 trial aims to understand the side effects of FX-111, how the body processes the drug, and whether FX-111 helps reduce or prevent the progression of mCRPC. The study focuses on men whose prostate cancer has advanced despite hormone therapy. Participants will take FX-111 orally once daily in continuous 28-day cycles. The study includes several dose levels of FX-111 to evaluate its safety and effects. Treatment will continue with regular monitoring for about six months. During this time, researchers will assess drug concentrations in the blood and measure PSA levels and tumor responses at scheduled intervals. Participants will have frequent physical exams and laboratory tests to monitor health and tumor status. PSA levels will be checked every four weeks, and tumor assessments will be done every eight weeks throughout the study. The main outcomes include tracking adverse events and how well the drug controls cancer growth. Participants will be followed for approximately six months to evaluate treatment effects and safety under medical supervision.
CONDITIONS
Brief Title
A Study in Patients With Metastatic Castration-Resistant Prostate Cancer
Research Team
J
Janine Koucheki, Associate Director, Clinical Operations
C
Carolyn McCrone, Sr Clinical Trial Associate
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
