RecruitingPhase 1NCT07719361

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

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


Sponsor

Flare Therapeutics Inc.

Enrollment

60 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called FX-111 for people with metastatic castration-resistant prostate cancer, neoplasms of prostate, and other related conditions. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFX-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

View Full Details on ClinicalTrials.gov

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NCT07719361


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