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A Study of FX-111 for Metastatic Castration-Resistant Prostate Cancer

This study is testing a drug called FX-111 for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and no longer responds to standard hormone therapy. The main goals are to see if FX-111 is safe, what side effects it might cause, and how your body processes the drug. Researchers also want to learn if FX-111 can help reduce or prevent the cancer from getting worse. You would take FX-111 by mouth once a day in 28-day cycles. The study doctor will monitor your health and tumor status through regular exams and lab tests. This study is currently recruiting up to 60 men who have confirmed prostate cancer that has progressed despite prior treatments.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 adult male participants.
What's involved
You would take FX-111 orally once daily in continuous 28-day cycles. You will have regular physical and laboratory examinations to check your health and tumor status.
Compensation
Not stated in the trial record.
Follow-up
The number of adverse events will be measured from Study day 1 throughout the study, estimated to be 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07719361

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Flare Therapeutics Inc.
~60 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:FX-111

At a glance

Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111
Measured over Study day 1 throughout the study, estimated to be 6 months.

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

Explore related trials

Prostate Carcinoma

Where it's being run

10 sites across 8 states
Texas3
California1
Massachusetts1
Michigan1
New Jersey1
South Carolina1
Tennessee1
Virginia1

Who to contact

Janine Koucheki, Associate Director, Clinical Operations
[email protected]
857-706-4400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111Study day 1 throughout the study, estimated to be 6 months.