Clinical Trials /

A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT03650491

Description:

This study will test the safety and efficacy of FOR46 given every 21 days to patients with relapsed or refractory multiple myeloma. The name of the study drug involved in this study is: FOR46 for Injection

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
  • Official Title: A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

Clinical Trial IDs

  • ORG STUDY ID: FOR46-002
  • NCT ID: NCT03650491

Conditions

  • Multiple Myeloma
  • Multiple Myeloma in Relapse
  • Multiple Myeloma With Failed Remission

Interventions

DrugSynonymsArms
FOR46Experimental: FOR46 (Dose Escalation)

Purpose

This study will test the safety and efficacy of FOR46 given every 21 days to patients with relapsed or refractory multiple myeloma. The name of the study drug involved in this study is: FOR46 for Injection

Detailed Description

      This study is designed to evaluate the safety, tolerability and antitumor activity of FOR46
      in patients with relapsed or refractory multiple myeloma. 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.
    

Trial Arms

NameTypeDescriptionInterventions
Experimental: 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
Experimental: 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 or female ≥ 18 years of age

          -  Measurable MM that is relapsed or refractory to established therapies with known
             clinical benefit in RRMM or intolerant of those established MM therapies. Prior lines
             of therapy must include a proteasome inhibitor (PI), an immunomodulatory imide drug
             (IMiD) and a CD38-directed therapy in any order of combination.

          -  ECOG performance status of 0 or 1

          -  Adequate hematologic, renal and hepatic function

          -  Females of child-bearing potential must have a negative serum pregnancy test and use a
             medically acceptable form of contraception

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

          -  Patients must provide signed informed consent

        Exclusion Criteria:

          -  Persistent clinically significant toxicities from previous anticancer therapy

          -  NCI CTCAE Grade ≥ 2 peripheral neuropathy from any etiology

          -  Has received treatment with a stem cell transplant within 12 weeks before
             administration of patient's first dose of FOR46

          -  Has had 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:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events
Time Frame:Through 1 month following last dose
Safety Issue:
Description:Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0.

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:Duration of response
Time Frame:From first dose through 6 months following last dose
Safety Issue:
Description:Assessed by IMWG criteria
Measure:Progression-free survival
Time Frame:From first dose through 6 months following last dose
Safety Issue:
Description:Assessed by IMWG criteria
Measure:Time to progression
Time Frame:From first dose through 6 months following last dose
Safety Issue:
Description:Assessed by IMWG criteria

Details

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

Last Updated

June 13, 2019