Health Trials

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

ConditionsMetastatic Castration Resistant Prostate CancermCRPCmCRPC (Metastatic Castration-resistant Prostate Cancer)Prostatic NeoplasmsProstatic Neoplasms, Castration-ResistantmCRPC or Advanced/Metastatic Solid TumorsmCRPC, Metastatic Castration Resistant Prostate CancerNeoplasms ProstateNeoplasms of Prostate
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorFlare Therapeutics Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • FX-111

Treatment groups

60 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Flare Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov