First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma

Summary

Primary Objectives: * Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B * Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM Secondary Objectives: * To characterize the safety profile of SAR442085 * To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent * To evaluate the potential immunogenicity of SAR442085 * To assess preliminary evidence of antitumor activity in the Dose Escalation Part A

Timeline

Start

2019-08-19

Primary completion

2022-08-29

Completion

2023-09-04

Publications

• Results Kapoor P, Nathwani N, Jelinek T, Pour L, Perrot A, Dimopoulos MA, Huang SY, Spicka I, Chhabra S, Lichtman E, Mateos MV, Kanagavel D, Zhao L, Guillemin-Paveau H, Mace S, van de Velde H, Richardson PG. An open-label, first-in-human, single agent, dose escalation study for the evaluation of safety and efficacy of SAR442085 in patients with relapsed or refractory multiple myeloma. Eur J Haematol. 2024 Nov;113(5):593-605. doi: 10.1111/ejh.14270. Epub 2024 Jul 12.

Drugs

Indications