A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
SAR446523: Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
Study 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
Primary outcome measure(s)
- Incidence of Dose Limiting Toxicities (DLTs)- Dose escalation (Part A) — Cycle 1 (28 days)
The incidence of DLTs will be evaluated using NCI CTCAE version 5.0 criteria. - Overall response rate (ORR) - Dose optimization (Part B) — 24 months after the Last Participant In (LPI)
ORR is defined as the proportion of participants with sCR, CR, VGPR, and PR assessed as per Investigator according to the 2016 IMWG response criteria.
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic in Arizona - Phoenix- Site Number : 8400005 | Phoenix | Arizona | Recruiting |
| Mayo Clinic in Florida- Site Number : 8400003 | Jacksonville | Florida | Recruiting |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400004 | Rochester | Minnesota | Recruiting |
| Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001 | Hackensack | New Jersey | Recruiting |
| Thomas Jefferson University Hospital- Site Number : 8400002 | Philadelphia | Pennsylvania | Recruiting |
| Investigational Site Number : 0360001 | Wollongong | New South Wales | Recruiting |
| Investigational Site Number : 0360002 | Melbourne | Victoria | Recruiting |
| Investigational Site Number : 1240005 | Vancouver | British Columbia | Recruiting |
| Investigational Site Number : 1240001 | Montreal | Quebec | Recruiting |
| Investigational Site Number : 1240002 | Sherbrooke | Quebec | Recruiting |
| Investigational Site Number : 2500002 | Lille | France | Recruiting |
| Investigational Site Number : 2500001 | Nantes | France | Recruiting |
| Investigational Site Number : 3760001 | Tel Aviv | Malopolskie | Recruiting |
| Investigational Site Number : 3760004 | Haifa | Israel | Recruiting |
| Investigational Site Number : 3760002 | Jerusalem | Israel | Recruiting |
| Investigational Site Number : 3800002 | Torette | Ancona | Recruiting |
| Investigational Site Number : 3800001 | Rozzano | Milano | Recruiting |
| Investigational Site Number : 7240002 | Barcelona | Barcelona [Barcelona] | Recruiting |
| Investigational Site Number : 7240001 | Madrid | Spain | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06630806 on ClinicalTrials.gov ↗ ← All trials in Italy