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