A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
Start Date
10/30/2024
Completion Date
5/16/2031
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.
Detailed Description
The study will be considered ongoing until the last participant last visit has occurred. Participants will be allowed to continue therapy until disease progression, unacceptable AEs, participant or Investigator's request to discontinue treatment.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
SAR446523
Conditions
Locations
Mayo Clinic in Arizona - Phoenix- Site Number : 8400005
Phoenix, Arizona 85054
United States
Mayo Clinic in Florida- Site Number : 8400003
Jacksonville, Florida 32224
United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400004
Rochester, Minnesota 55905
United States
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001
Hackensack, New Jersey 07601
United States
Thomas Jefferson University Hospital- Site Number : 8400002
Philadelphia, Pennsylvania 19107
United States
Investigational Site Number : 0360001
Wollongong, New South Wales 2500
Australia
Investigational Site Number : 0360002
Melbourne, Victoria 3065
Australia
Investigational Site Number : 1240005
Vancouver, British Columbia V5Z 1L3
Canada
Investigational Site Number : 1240001
Montreal, Quebec H4A 3J1
Canada
Investigational Site Number : 1240002
Sherbrooke, Quebec J1H 5N4
Canada
Investigational Site Number : 2500002
Lille, 59037
France
Investigational Site Number : 2500001
Nantes, 44093
France
Investigational Site Number : 3760001
Tel Aviv, Malopolskie 6423906
Israel
Investigational Site Number : 3760004
Haifa, 3109601
Israel
Investigational Site Number : 3760002
Jerusalem, 9112001
Israel
Investigational Site Number : 3800002
Torette, Ancona 60020
Italy
Investigational Site Number : 3800001
Rozzano, Milano 20089
Italy
Investigational Site Number : 7240002
Barcelona, Barcelona [Barcelona] 08035
Spain
Investigational Site Number : 7240001
Madrid, 28040
Spain