Actively Recruiting
Safety and Effects of Oral FX-111 in Adult Men with Advanced Metastatic Castration-Resistant Prostate Cancer
Led by Flare Therapeutics Inc. · Updated on 2026-08-04
60
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of FX-111 in adult men with metastatic castration-resistant prostate cancer mCRPC. This phase 1 trial aims to understand the side effects of FX-111, how the body processes the drug, and whether FX-111 helps reduce or prevent the progression of mCRPC. The study focuses on men whose prostate cancer has advanced despite hormone therapy. Participants will take FX-111 orally once daily in continuous 28-day cycles. The study includes several dose levels of FX-111 to evaluate its safety and effects. Treatment will continue with regular monitoring for about six months. During this time, researchers will assess drug concentrations in the blood and measure PSA levels and tumor responses at scheduled intervals. Participants will have frequent physical exams and laboratory tests to monitor health and tumor status. PSA levels will be checked every four weeks, and tumor assessments will be done every eight weeks throughout the study. The main outcomes include tracking adverse events and how well the drug controls cancer growth. Participants will be followed for approximately six months to evaluate treatment effects and safety under medical supervision.
CONDITIONS
Brief Title
A Study in Patients With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed adenocarcinoma of the prostate.
- PSA levels 2 2 ng/mL at screening.
- Progressing PSA with two consecutive increases at least 1 week apart.
- Progressed on androgen deprivation therapy and at least one prior androgen receptor pathway inhibitor.
- Ongoing primary androgen deprivation therapy without bilateral orchiectomy.
- Acceptable physical functioning and laboratory results.
- Discontinued prior therapies within protocol-defined timeframes.
- Commitment to use highly effective contraception during the study and for 90 days after.
- Willing and able to follow study visit schedule and requirements.
You will not qualify if you...
- Predominance of small cell carcinoma or neuroendocrine prostate cancer in recent biopsy.
- Brain metastases needing ongoing radiation or high-dose steroids.
- Not recovered from side effects of prior surgery or cancer treatments.
- Active viral, bacterial, or fungal infections requiring treatment.
- Prior treatment with androgen receptor degraders or AR ligand-targeting molecules.
- Blood clots within 4 weeks before treatment start.
- Concurrent malignancy requiring treatment or history of malignancy active within 2 years unless stable.
- Severe or uncontrolled systemic diseases.
- Any condition interfering with study evaluation or safety as judged by the investigator.
Research Team
J
Janine Koucheki, Associate Director, Clinical Operations
C
Carolyn McCrone, Sr Clinical Trial Associate
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