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

NCT04000282 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-09-12

No results posted yet for this study

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

Conditions

  • Plasma Cell Myeloma

Interventions

DRUG

SAR442085

Pharmaceutical form:Sterile lyophilized powder for reconstitution for infusion Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2022-08-29
Completion
2023-09-04
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Greece
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04000282 on ClinicalTrials.gov