Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients with Relapsed or Refractory Multiple Myeloma

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2019-006
    NCT ID
    • NCT03761108
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator
    • Jeffrey
      Zonder, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Objective
    • In the Phase 1 portion of the study: To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended Phase 2 dose regimen (RP2DR) (defined as either a maximum tolerated dose regimen [MTDR] or biologically effective dose regimen [BEDR]) of REGN5458 as monotherapy in patients with relapsed or refractory MM who have exhausted therapeutic options that are expected to provide meaningful clinical benefit. The determination of the RP2DR will be based on the review of non-clinical and all clinical data, including that pertaining to safety, pharmacokinetics (PK), PK/PD (pharmacokinetic/pharmacodynamic) relationships, and efficacy.
    • In the Phase 2 portion of the study: To assess the preliminary anti-tumor activity of REGN5458
    Secondary Objectives
    • In the Phase 1 and 2 portion:
    • To assess the preliminary anti-tumor activity of REGN5458 as measured by duration of response (DOR), PFS, rate of minimal residual disease (MRD) negative status, and OS
      To evaluate the pharmacokinetic (PK) properties of REGN5458
      To characterize the immunogenicity of REGN5458
    • In the Phase 1 portion only:
    • To assess the preliminary anti-tumor activity of REGN5458
    • In the Phase 2 portion only:
    • To evaluate the safety and tolerability of REGN5458
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266