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A Phase 1 Study in Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor: Flare Therapeutics Inc.
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.
Official title: A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With Metastatic Castration-Resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-07
Completion Date
2029-02-15
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Locations (10)
START Los Angeles
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
START New Jersey
East Brunswick, New Jersey, United States
START Carolinas
Myrtle Beach, South Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
START Dallas-Fort Worth
Fort Worth, Texas, United States
NEXT Houston
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States