A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Summary

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

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.

Conditions9

Interventions1

Locations10 sites

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