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

Plasma Cell Myeloma Clinical Trial

Official title: 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 Terminated

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

• NCT number: NCT04000282
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 1
• Start date: August 19, 2019
• Completion date: September 4, 2023