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RECRUITING
NCT07719361
PHASE1

A Phase 1 Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor: Flare Therapeutics Inc.

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.

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

Interventions

DRUG

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