NCT03761108: Phase 1/2 - REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Refractory MM

(LINKER-MM1)

RRMM

First in Human (FIH) Study of REGN5458 in Patients With Relapsed or Refractory Multiple Myeloma

The primary objectives of the study are:

Phase 1: 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) who have exhausted therapeutic options

Phase 2: To assess the preliminary anti-tumor activity of REGN5458

The secondary objectives of the study are: To evaluate the pharmacokinetic (PK) properties of REGN5458, To characterize the immunogenicity of REGN5458

Phase 1: To assess the preliminary anti-tumor activity of REGN5458

Phase 2: To evaluate the safety and tolerability of REGN5458 , To evaluate the correlation between the activity of REGN5458 and PK

Sponsor

Regeneron Pharmaceutical

Multiple Locations

International Stud