Condition: Plasma Cell Myeloma Refractory · Sponsor: Sanofi
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.
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
Always discuss trial participation with your own doctor first.
| Mayo Clinic in Arizona - Phoenix- Site Number : 8400005 | Phoenix, Arizona, United States | Recruiting |
| Mayo Clinic in Florida- Site Number : 8400003 | Jacksonville, Florida, United States | Recruiting |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400004 | Rochester, Minnesota, United States | Recruiting |
| Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001 | Hackensack, New Jersey, United States | Recruiting |
| Thomas Jefferson University Hospital- Site Number : 8400002 | Philadelphia, Pennsylvania, United States | Recruiting |
| Investigational Site Number : 0360001 | Wollongong, New South Wales, Australia | Recruiting |
| Investigational Site Number : 0360002 | Melbourne, Victoria, Australia | Recruiting |
| Investigational Site Number : 1240005 | Vancouver, British Columbia, Canada | Recruiting |
| Investigational Site Number : 1240001 | Montreal, Quebec, Canada | Recruiting |
| Investigational Site Number : 1240002 | Sherbrooke, Quebec, Canada | Recruiting |
| Investigational Site Number : 2500002 | Lille, France | Recruiting |
| Investigational Site Number : 2500001 | Nantes, France | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06630806