Clinical Trial

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are: What are the side effects of FX-111? Does FX-111 work to reduce or prevent progression of mCRPC? The study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-07-17; most recent amendment 2026-07-23.
Trial Details
NCT Number NCT07719361
Lead Sponsor Flare Therapeutics Inc.
Conditions Metastatic Castration Resistant Prostate Cancer, mCRPC, mCRPC (Metastatic Castration-resistant Prostate Cancer), Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, mCRPC or Advanced/Metastatic Solid Tumors, mCRPC, Metastatic Castration Resistant Prostate Cancer, Neoplasms Prostate +1 more
Enrollment 60 participants
Start Date 2026-07-01
Primary Completion 2028-02-15 (estimated)
Study Completion 2029-02-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-04