RecruitingPhase 1NCT06630806

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

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

Sponsor

Sanofi

Enrollment

87 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

Plasma Cell Myeloma Refractory

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SAR446523, given by injection under the skin, in people with multiple myeloma (a blood cancer affecting plasma cells) that has come back or stopped responding to at least three prior treatments. **You may be eligible if...** - You have been diagnosed with multiple myeloma with measurable disease - You have received at least 3 prior lines of treatment that are no longer working - Your overall health is adequate enough to participate (ECOG 0-1) **You may NOT be eligible if...** - Your ECOG performance status is 2 or higher (meaning significant daily activity limitations) - You have a related plasma cell condition called AL amyloidosis, POEMS syndrome, or plasma cell leukemia - You have central nervous system involvement from myeloma - You had systemic myeloma treatment within the past 14 days - You have inadequate organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSAR446523

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

View Full Details on ClinicalTrials.gov

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NCT06630806

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