A Study in Patients With Metastatic Castration-Resistant Prostate Cancer
Eligible age
18+ yrs
Accepts
Men
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: Flare Therapeutics Inc.
You may qualify if…
- ✓ Confirmed adenocarcinoma of the prostate.
- ✓ PSA levels ≥ 2 ng/mL at screening visit.
- ✓ Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.
- ✓ 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).
- ✓ Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.
- ✓ Acceptable physical functioning and laboratory measurements, per the study protocol.
- ✓ Discontinued prior therapies within protocol-specified timeframes.
- ✓ Commit to use of highly-effective contraception while on study and for 90 days after.
You may not qualify if…
- ✕ Predominance of small cell carcinoma of the prostate/neuroendocrine prostate cancer in most recent tumor biopsy.
- ✕ Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.
- ✕ Not recovered from side effects of prior surgery or cancer treatments.
- ✕ Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.
- ✕ Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).
- ✕ Blood clots ≤ 4 weeks prior to start of treatment.
- ✕ Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.
- ✕ Any evidence of severe or uncontrolled systemic diseases.
Where it's recruiting
Los Angeles
Boston
Grand Rapids
East Brunswick
Myrtle Beach
Nashville
Fort Worth · Houston · San Antonio
Source: ClinicalTrials.gov · NCT07719361 · last updated 2026-09-24