Clinical Trials /

Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799

Description:

The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564 (Part 1 [Dose Escalation]) and to further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma
  • Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized DuoBody® Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: CR108404
  • SECONDARY ID: 2017-002400-26
  • SECONDARY ID: 64407564MMY1001
  • NCT ID: NCT03399799

Conditions

  • Hematological Malignancies

Interventions

DrugSynonymsArms
JNJ-64407564Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)

Purpose

The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564 (Part 1 [Dose Escalation]) and to further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).

Detailed Description

      The study will be conducted in 2 parts, separately for intravenous (IV) and subcutaneous (SC)
      administration: dose escalation and dose expansion. The study will evaluate safety,
      tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564
      administered to adult participants with relapsed or refractory multiple myeloma. The overall
      safety of the study drug will be assessed by physical examinations, Eastern Cooperative
      Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse
      event monitoring, and concomitant medication usage. Disease evaluations will include
      peripheral blood and bone marrow assessments at screening (performed within 28 days) and to
      confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The
      end of study (study completion) is defined as the last study assessment for the last
      participant in the study.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)ExperimentalParticipants will receive IV infusion of JNJ-64407564 at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data.
  • JNJ-64407564
Part 1: Dose Escalation (JNJ-64407564) - Subcutaneous (SC)ExperimentalParticipants will receive JNJ-64407564 SC. The dose levels will be selected to identify safe and tolerable putative RP2D(s).
  • JNJ-64407564
Part 2: Dose Expansion (JNJ-64407564)ExperimentalParticipants will receive IV infusion or SC injection of JNJ-64407564 at each putative recommended Phase 2 dose(s) (RP2D[s]) as determined in Part 1.
  • JNJ-64407564

Eligibility Criteria

        Inclusion Criteria:

          -  Documented initial diagnosis of multiple myeloma according to International Myeloma
             Working Group (IMWG) diagnostic criteria

          -  Participants with measurable multiple myeloma who have progressed on, or could not
             tolerate, all available established therapies

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

          -  Women of childbearing potential must have a negative pregnancy test at screening and
             prior to the first dose of study drug using a highly sensitive pregnancy test either
             serum (Beta human chorionic gonadotropin [beta-hCG]) or urine

          -  Sign an informed consent form (ICF) indicating that he or she understands the purpose
             of and procedures required for the study, and is willing to and able participate in
             the study. Consent is to be obtained prior to the initiation of any study-related
             tests or procedures that are not part of standard-of-care for the participant's
             disease

        Exclusion Criteria:

          -  Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the
             product manufacturer prior to the first dose, during treatment, or within 100 days of
             the last dose of JNJ-64407564

          -  Toxicities from previous anticancer therapies should have resolved to baseline levels
             or to Grade 1 or less except for alopecia or peripheral neuropathy

          -  Received a cumulative dose of corticosteroids equivalent to greater than or equal to (
             >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of
             study drug

          -  An allogenic stem cell transplant within 6 months before first dose of study drug.
             Participants who received an allogeneic transplant must be off all immunosuppressive
             medications for 6 weeks without signs of graft-versus-host disease (GVHD); and/or an
             autologous stem cell transplant less than or equal to (<=) 12 weeks before first dose
             of study drug

          -  Documented history of central nervous system (CNS) involvement or exhibits clinical
             signs of meningeal involvement of multiple myeloma. If either is suspected, whole body
             magnetic resonance imaging (MRI) and lumbar cytology are required
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1: Dose-limiting Toxicity (DLT)
Time Frame:Up to Day 28
Safety Issue:
Description:The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.

Secondary Outcome Measures

Measure:Part 1: JNJ-64407564 Serum Concentrations
Time Frame:Up to 8 weeks
Safety Issue:
Description:Serum concentrations will be calculated for JNJ-64407564.
Measure:Part 1 and Part 2: Biomarker Assessment
Time Frame:Up to Cycle 7 Day 1 (each cycle of 21-days)
Safety Issue:
Description:Serum cytokine concentrations will be measured pre- and post-infusion of JNJ-64407564 for biomarker assessment.
Measure:Part 1: Number of Participants with JNJ-64407564 Antibodies
Time Frame:Up to 8 weeks
Safety Issue:
Description:Antibodies to JNJ-64407564 will be assessed to evaluate potential immunogenicity.
Measure:Part 2: Overall Response Rate (ORR)
Time Frame:Approximately 2.10 years
Safety Issue:
Description:ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.
Measure:Part 2: Clinical Benefit Rate (CBR)
Time Frame:Approximately 2.10 years
Safety Issue:
Description:CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria.
Measure:Part 2: Duration of Response (DOR)
Time Frame:From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (approximately 2.10 years)
Safety Issue:
Description:DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.
Measure:Part 2: Time to Response (TTR)
Time Frame:From the date of first dose of study drug to the date of initial documentation of a response (approximately 2.10 years)
Safety Issue:
Description:TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
Measure:Part 2: Progression-Free Survival (PFS)
Time Frame:From the date of first dose of study drug to the date of first documented progressive disease, or death, whichever occurs first (approximately 18 months)
Safety Issue:
Description:PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

November 7, 2019