NCT04000282

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

An Open-label, First-in-human, Single Agent, Dose-escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442085 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

Patient will continue to receive study medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason why investigator considers it appropriate to discontinue study medication. Once permanently discontinued, study medication cannot be restarted at later timepoint.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	SAR442085	Pharmaceutical form:Sterile lyophilized powder for reconstitution for infusion Route of administration: intravenous

Timeline

• Start date: 2019-08-19
• Primary completion: 2022-08-29
• Completion: 2023-09-04
• First posted: 2019-06-27
• Last updated: 2025-09-12

Locations

12 sites across 6 countries: United States, Czechia, France, Greece, Spain, Taiwan

Regulatory

• FDA-regulated drug study