First in Human (FIH) Study of REGN5458 in Patients With Relapsed or Refractory Multiple Myeloma
Status:
Recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
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