A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With Metastatic Castration-Resistant Prostate Cancer

Study Identifier:
FX-111-CLINPRO-1
CT.gov Identifier:
NCT07719361
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: FX-111 Dose Level 1
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Drug: Drug: FX-111
Drug: FX-111 will be administered orally once daily in continuous 28-day cycles.
Drug: EXPERIMENTAL: FX-111 Dose Level 2
Drug: EXPERIMENTAL: FX-111 Dose Level 3
Drug: EXPERIMENTAL: FX-111 Dose Level 4
Drug: EXPERIMENTAL: FX-111 Dose Level 5
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Recruiting
Condition(s) Treated at Site
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Salwan Al Mutar
Status
Recruiting
Condition(s) Treated at Site
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Bruno Fang
Status
Recruiting
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Emerson Lim
Status
Recruiting
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruiting
Condition(s) Treated at Site