MedTrace Logo

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT07719361 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-04

No results posted yet for this study

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.

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
  • Neoplasms of Prostate

Interventions

DRUG

FX-111

FX-111 will be administered orally once daily in continuous 28-day cycles.

Sponsors & Collaborators

  • Flare Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-02-15
Completion
2029-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07719361 on ClinicalTrials.gov