NCT04083534: Phase 1/2: First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed RRMM

Anti-BCMA x Anti-CD3 Bispecific Antibody REGN5459

NCT04083534: Phase 1/2: First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)

First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)

In the phase 1 portion of the study, the primary objectives are to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit.

In the phase 2 portion of the study, the primary objective is to assess the preliminary anti-tumor activity of REGN5459 as measured by objective response rate (ORR).

Sponsor

Regeneron Pharmaceuticals

Multiple Locations

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ClinicalTrials.gov Identifier: NCT04083534

Official Title: Phase 1/2 FIH Study of REGN5459 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma

First Posted : September 10, 2019

Click here for details on ClinicalTrials.gov

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Drug: REGN5459

REGN5459

Anti-BCMA/Anti-CD3 Bispecific Antibody REGN5459 (Code C165656)