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OncoMatch/Clinical Trials/NCT07719361

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Is NCT07719361 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies FX-111 for metastatic castration resistant prostate cancer.

Phase 1RecruitingFlare Therapeutics Inc.NCT07719361Data as of Sep 2026

Treatment: FX-111The 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.

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Extracted eligibility criteria

Treatments studied

Other

FX-111

Cancer type

Prostate Cancer

Disease stage

Required: Stage IV

Metastatic disease required

Metastatic Castration-Resistant Prostate Cancer

Demographics

Male only

Prior therapy

Min 1 prior line

Must have received: androgen receptor pathway inhibitor (apalutamide, darolutamide, abiraterone, enzalutamide) — castration-sensitive or castration-resistant prostate cancer

Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide)

Cannot have received: androgen receptor degrader or AR ligand-directed therapy

Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • START Los Angeles · Los Angeles, California
  • Massachusetts General Hospital · Boston, Massachusetts
  • START Midwest · Grand Rapids, Michigan
  • START New Jersey · East Brunswick, New Jersey
  • START Carolinas · Myrtle Beach, South Carolina

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07719361 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior androgen receptor degrader or AR ligand-directed therapy disqualifies patients from enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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