Clinical Trials /

Dose Escalation Study of JNJ-64007957, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

NCT03145181

Description:

The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for JNJ-64007957 and to characterize the safety and tolerability of JNJ-64007957 at the RP2Ds.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Dose Escalation Study of JNJ-64007957, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
  • Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64007957, a Humanized BCMA x CD3 DuoBody® Antibody in Subjects With Relapsed or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: CR108206
  • SECONDARY ID: 2016-002122-36
  • SECONDARY ID: 64007957MMY1001
  • NCT ID: NCT03145181

Conditions

  • Hematological Malignancies

Interventions

DrugSynonymsArms
JNJ-64007957 (IV)Part 1: Dose Escalation (IV)
JNJ-64007957 (SC)Part 1: Dose Escalation (SC)

Purpose

The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for JNJ-64007957 and to characterize the safety and tolerability of JNJ-64007957 at the RP2Ds.

Detailed Description

      The study will be conducted in 2 parts, separately for IV and SC administration: dose
      escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability,
      pharmacokinetics and preliminary antitumor activity of JNJ-64007957 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 on
      study.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose Escalation (IV)ExperimentalParticipants will receive JNJ-64007957 intravenously (IV).
  • JNJ-64007957 (IV)
Part 2: Dose Expansion (IV)ExperimentalParticipants will receive JNJ-64007957 IV.
  • JNJ-64007957 (IV)
Part 1: Dose Escalation (SC)ExperimentalParticipants will receive JNJ-64007957 subcutaneously (SC).
  • JNJ-64007957 (SC)
Part 2: Dose Expansion (SC)ExperimentalParticipants will receive JNJ-64007957 SC.
  • JNJ-64007957 (SC)

Eligibility Criteria

        Inclusion Criteria:

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

          -  Measurable multiple myeloma that is relapsed or refractory to established therapies
             with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant
             of those established multiple myeloma therapies, and a candidate for JNJ-64007957
             treatment in the opinion of the treating physician. Prior lines of therapy must
             include a proteasome inhibitor and an immunomodulatory drug in any order during the
             course of treatment. Participants who could not tolerate a proteasome inhibitor or
             immunomodulatory drugs are allowed.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

          -  Women of childbearing potential and fertile men who are sexually active must agree to
             use a highly effective method of contraception (less than [<] 1%/year failure rate)
             during the study and for 90 days after the last dose of study drug. Contraception must
             be consistent with local regulations regarding the use of birth control methods for
             participants participating in clinical trials. When a woman is of childbearing
             potential the following are required: Participants must agree to practice a highly
             effective method of contraception (failure rate of <1% per year when used consistently
             and correctly). Examples of highly effective contraceptives for women include
             user-independent methods (for example, implantable progestogen-only hormone
             contraception associated with inhibition of ovulation; intrauterine device;
             intrauterine hormone-releasing system; vasectomized partner) and user-dependent
             methods (for example: combined [estrogen- and progestogen-containing] hormonal
             contraception associated with inhibition of ovulation [oral/intravaginal/
             transdermal]; progestogen-only hormone contraception associated with inhibition of
             ovulation [oral/injectable]. In addition to the highly effective method of
             contraception, a man who is sexually active with a woman of childbearing potential
             must agree to use a barrier method of contraception (for example a condom with
             spermicidal foam/gel/film/cream/suppository). Additionally, a man who is sexually
             active with a woman who is pregnant must use a condom. Women and men must agree not to
             donate eggs (ova, oocytes) or sperm, respectively, during the study and for 90 days
             after the last dose of study drug

          -  Participants must 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
             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:

          -  Prior treatment with any B cell maturation antigen (BCMA) targeted therapy

          -  Prior antitumor therapy as follows, before the first dose of study drug: Targeted
             therapy, epigenetic therapy, or treatment with an investigational drug or used an
             invasive investigational medical device within 21 days or at least 5 half-lives,
             whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days;
             Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days;
             Immunomodulatory agent therapy within 7 days; Radiotherapy within 21 days. However, if
             the radiation portal covered less than or equal to (<=) 5% of the bone marrow reserve,
             the participant is eligible irrespective of the end date of radiotherapy

          -  Toxicities from previous anticancer therapies that have not resolved to baseline
             levels or to Grade 1 or less except for alopecia or peripheral neuropathy

          -  Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of
             prednisone within the 14-day period before the first dose of study drug (does not
             include pretreatment medication)

          -  Known active central nervous system (CNS) involvement or exhibits clinical signs of
             meningeal involvement of multiple myeloma
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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:JNJ-64007957 Serum Concentrations
Time Frame:Up to 8 weeks
Safety Issue:
Description:Concentration assessment will be done to evaluate the effect of JNJ-64007957.
Measure:Number of Participants with JNJ-64007957 Antibodies
Time Frame:Up to 8 weeks
Safety Issue:
Description:Antibodies to JNJ-64007957 will be assessed to evaluate potential immunogenicity.
Measure:Preliminary Antitumor Activity of JNJ‑64007957 at the RP2D(s) in Part 2
Time Frame:Up to End of Treatment (Approximately 91 days)
Safety Issue:
Description:Preliminary antitumor activity of JNJ‑64007957 will be done using the International Myeloma Working Group (IMWG) response criteria.
Measure:Biomarker Assessment
Time Frame:Up to 8 weeks
Safety Issue:
Description:Biomarker assessment may be done to evaluate the effect of JNJ‑64007957.

Details

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

Last Updated

November 7, 2019