Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients with Relapsed or Refractory Multiple Myeloma

Description

The primary objectives of the study are: In the phase 1 portion of the study: To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine one or more recommended phase 2 dose regimens (RP2DRs) of REGN5458 as monotherapy in patients with relapsed or refractory multiple myeloma (MM). In the phase 2 portion of the study: To assess the anti-tumor activity of REGN5458 as measured by objective response rate (ORR) and as separately in cohorts 1 and 2, determined by an Independent Review Committee (IRC) in patients who have progressed on or after 3 prior lines of therapy or who are triple-refractory (defined as refractory to a(n) proteasome inhibitor (PI), immunomodulatory imide (IMiD) drug (s), and anti-cluster of differentiation 38 (anti-CD38) monoclonal antibody). The secondary objectives of the study are: In the phase 1 dose escalation portion: - To assess the preliminary anti-tumor activity of REGN5458 as determined by the investigator and measured by ORR, duration of response (DOR), progression-free survival (PFS), rate of minimal residual disease (MRD) negative status, and overall survival (OS) - To evaluate the pharmacokinetic (PK) properties of REGN5458 - To characterize the immunogenicity of REGN5458 In the phase 2 for each cohort: - To assess the anti-tumor activity of REGN5458 as measured by: ORR, DOR, PFS, as determined by an IRC and the investigator, rate of MRD negative status and OS - To evaluate the effects of REGN5458 on health-related quality of life (HRQoL) and patient-reported functions and symptoms - To evaluate the safety and tolerability of REGN5458 - To evaluate the PK properties of REGN5458 - To characterize the immunogenicity of REGN5458

Resources and Links

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT03761108