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 a recommended phase 2 dose regimen (RP2DR) 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 determined by an Independent Review Committee (IRC) 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: - 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