A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Official title

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

Overview

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.

Interventions

• Drug FX-111
  FX-111 will be administered orally once daily in continuous 28-day cycles.

Primary outcome measures

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

Secondary outcome measures (6)

• Area Under the Concentration Time Curve [Time frame: Study day 1 throughout the study for 6 months.]
• Maximum concentration (Cmax) of FX-111 in the bloodstream. [Time frame: Study day 1 throughout the study for 6 months.]
• Time required (Tmax) to reach Cmax of FX-111 in the bloodstream. [Time frame: Study day 1 throughout the study for 6 months.]
• Rate of confirmed prostate-specific antigen (PSA) decline of ≥ 50% from baseline (PSA50). [Time frame: Baseline and every 4 weeks throughout the study, estimated to be 6 months.]
• Objective Response Rate (ORR) [Time frame: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.]
• Duration of Response (DoR) [Time frame: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 10 centers

• START Los Angeles — Los Angeles
• Massachusetts General Hospital — Boston
• START Midwest — Grand Rapids
• START New Jersey — East Brunswick
• START Carolinas — Myrtle Beach
• Tennessee Oncology — Nashville
• START Dallas-Fort Worth — Fort Worth
• NEXT Houston — Houston
• … and 2 more centers

Identifiers

NCT: NCT07719361 · FX-111-CLINPRO-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗