Clinical Trials /

A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT03575819

Description:

This study will test the safety and efficacy of FOR46 given every 21 days to patients with metastatic castration-resistant prostate cancer. The name of the study drug involved in this study is: FOR46 for Injection (FOR46)

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Official Title: A Phase 1 Study of FOR46 Administered Every 21 Days in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Clinical Trial IDs

  • ORG STUDY ID: FOR46-001
  • NCT ID: NCT03575819

Conditions

  • Prostate Cancer Metastatic

Interventions

DrugSynonymsArms
FOR46FOR46 (Dose Escalation)

Purpose

This study will test the safety and efficacy of FOR46 given every 21 days to patients with metastatic castration-resistant prostate cancer. The name of the study drug involved in this study is: FOR46 for Injection (FOR46)

Detailed Description

      This study is designed to evaluate the safety, tolerability and antitumor activity of FOR46
      in patients with metastatic castration-resistant prostate cancer. This study will be
      conducted in two parts:

      Dose escalation:

      This part will evaluate increasing doses of FOR46 to identify the maximum tolerated dose
      (MTD). The first patient enrolled on the study will receive the lowest dose of FOR46. Once
      this dose is shown to be safe, a second patient will be enrolled at the next higher dose.
      Patients will continue to be enrolled into either single or multiple patient groups receiving
      increasing doses until the MTD is reached.

      Dose expansion:

      This part of the study will further evaluate the safety, tolerability and antitumor activity
      of FOR46 at a dose shown to be safe in the dose escalation part of the study. Patients will
      be enrolled into 1 of 2 groups, based on histology.
    

Trial Arms

NameTypeDescriptionInterventions
FOR46 (Dose Escalation)ExperimentalEligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will be enrolled into escalating dose levels during the Dose Escalation period of the study.
  • FOR46
FOR46 (Dose Expansion)ExperimentalEligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will receive the maximum tolerated dose during the Dose Expansion period of the study.
  • FOR46

Eligibility Criteria

        Inclusion Criteria:

          -  Male ≥ 18 years of age

          -  Has histologically confirmed prostate cancer that is metastatic and has progressed as
             defined by PCWG3 criteria during or after treatment with at least 1 ASI (eg,
             abiraterone, enzalutamide, apalutamide), or another second-generation anti-androgen or
             cytochrome P450 (CYP)17A1 inhibitor, with the most recent ASI administered in the
             castration-resistant setting

          -  Has serum testosterone levels < 50 ng/dL during screening. Patients without a history
             of bilateral orchiectomy are required to remain on luteinizing hormone-releasing
             hormone (LHRH) analog during the course of protocol therapy

          -  ECOG performance status of 0 or 1

          -  Adequate hematologic, renal and hepatic function

          -  Males with female partners of childbearing potential must agree to use 2 effective
             methods of contraception

          -  Patients must provide signed informed consent

          -  Patients enrolled into the dose expansion phase must be willing to undergo a
             metastatic tumor biopsy or has tissue available from a prior post-castration resistant
             tumor biopsy

        Exclusion Criteria:

          -  Persistent clinically significant toxicities from previous anticancer therapy

          -  Prior treatment with cytotoxic chemotherapy for mCRPC (chemotherapy in the
             hormone-sensitive setting is allowed if > 6 months before study entry)

          -  Has received external-beam radiation or systemic anticancer therapy within 14 days
             before first dose of FOR46

          -  Has received treatment with an investigational drug within 28 days before first dose
             of FOR46

          -  Clinically significant cardiovascular disease

          -  Uncontrolled, clinically significant pulmonary disease

          -  Uncontrolled intercurrent illness

          -  Requires medications that are strong inhibitors or strong inducers of CYP3A4
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of toxicity
Time Frame:Through 1 month following last dose
Safety Issue:
Description:Type, incidence, severity, seriousness, and relatedness of adverse events.

Secondary Outcome Measures

Measure:Characterize FOR46 plasma concentration
Time Frame:Through 1 month following last dose
Safety Issue:
Description:FOR46 maximum plasma concentration
Measure:Characterize the FOR46 area under the curve
Time Frame:Through 1 month following last dose
Safety Issue:
Description:FOR46 area under the plasma concentration-time curve
Measure:Characterize FOR46 elimination
Time Frame:Through 1 month following last dose
Safety Issue:
Description:FOR46 elimination half-life
Measure:Antidrug Antibodies
Time Frame:Through 1 month following last dose
Safety Issue:
Description:Change from baseline in serum levels of antidrug antibodies
Measure:Median radiographic progression-free survival
Time Frame:12 months
Safety Issue:
Description:Assessed by Prostate Cancer Clinical Trials Working Group 3 criteria

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Fortis Therapeutics, Inc.

Trial Keywords

  • castration-resistant
  • androgen-signaling blockade progression

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