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A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

NCT06630806 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-03-25

No results posted yet for this study

Summary

This is a first-in-human study of SAR446523 conducted in patients with RRMM.

The study consists of two parts:

Dose escalation (Part A): In this part, up to several dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part.

Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.

Conditions

  • Plasma Cell Myeloma Refractory

Interventions

DRUG

SAR446523

Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2031-05-16
Completion
2031-05-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Israel
  • Italy
  • Spain

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 NCT06630806 on ClinicalTrials.gov