Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06630806
PHASE1

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: A First-in-human, Open-label, Phase 1 Study to Evaluate the Safety, Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SAR446523, an Anti-GPRC5D ADCC-enhanced Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

87

Start Date

2024-10-30

Completion Date

2031-05-16

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

SAR446523

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

Locations (19)

Mayo Clinic in Arizona - Phoenix- Site Number : 8400005

Phoenix, Arizona, United States

Mayo Clinic in Florida- Site Number : 8400003

Jacksonville, Florida, United States

Mayo Clinic in Rochester - Minnesota- Site Number : 8400004

Rochester, Minnesota, United States

Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001

Hackensack, New Jersey, United States

Thomas Jefferson University Hospital- Site Number : 8400002

Philadelphia, Pennsylvania, United States

Investigational Site Number : 0360001

Wollongong, New South Wales, Australia

Investigational Site Number : 0360002

Melbourne, Victoria, Australia

Investigational Site Number : 1240005

Vancouver, British Columbia, Canada

Investigational Site Number : 1240001

Montreal, Quebec, Canada

Investigational Site Number : 1240002

Sherbrooke, Quebec, Canada

Investigational Site Number : 2500002

Lille, France

Investigational Site Number : 2500001

Nantes, France

Investigational Site Number : 3760001

Tel Aviv, Malopolskie, Israel

Investigational Site Number : 3760004

Haifa, Israel

Investigational Site Number : 3760002

Jerusalem, Israel

Investigational Site Number : 3800002

Torette, Ancona, Italy

Investigational Site Number : 3800001

Rozzano, Milano, Italy

Investigational Site Number : 7240002

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240001

Madrid, Spain