FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study evaluates FX-111 in adult men with metastatic castration-resistant prostate cancer to determine its safety, how the body processes the drug, and whether it shows signs of activity against the cancer. Participants take FX-111 by mouth daily and undergo regular physical exams, lab tests, and tumor assessments. The trial will monitor side effects and trends in prostate-specific antigen (PSA) and disease progression to inform future research. Eligible participants have progressed on prior therapies and continue ADT while meeting health and laboratory criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Willing and able to adhere to the study visit schedule and other protocol defined requirements.

Exclusion Criteria:

* 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.
* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.

Where it's running

• START Los Angeles
  Los Angeles, California, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• START New Jersey
  East Brunswick, New Jersey, United States Recruiting
• START Carolinas
  Myrtle Beach, South Carolina, United States Recruiting
• START Dallas-Fort Worth
  Fort Worth, Texas, United States Recruiting
• NEXT Houston
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Janine Koucheki, Associate Director, Clinical Operations
• Email: clinops@flaretx.com
• Phone: 857-706-4400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.