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NCT06630806 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
A Phase 1 study of Plasma Cell Myeloma Refractory, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
- 18
- Study locations
NCT06630806: Recruiting Phase 1 study of Plasma Cell Myeloma Refractory, sponsored by Sanofi.
NCT06630806 is a Phase 1 study of Plasma Cell Myeloma Refractory that is actively recruiting participants, run by Sanofi. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). The trial reports 18 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06630806, a Phase 1 study of Plasma Cell Myeloma Refractory, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
- 18
- Study locations
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 6 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.
Primary Outcome
The incidence of DLTs will be evaluated using NCI CTCAE version 5.0 criteria.
Conditions Studied
Interventions
- DRUG SAR446523
Study Locations (18)
Other
- Investigational Site Number : 2500002 - Lille
- Investigational Site Number : 2500001 - Nantes
- Investigational Site Number : 3760004 - Haifa
- Investigational Site Number : 3760002 - Jerusalem
- Investigational Site Number : 7240001 - Madrid
Quebec
- Investigational Site Number : 1240001 - Montreal
- Investigational Site Number : 1240002 - Sherbrooke
Arizona
- Mayo Clinic in Arizona - Phoenix- Site Number : 8400005 - Phoenix
Florida
- Mayo Clinic in Florida- Site Number : 8400003 - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400004 - Rochester
New Jersey
- Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001 - Hackensack
Pennsylvania
- Thomas Jefferson University Hospital- Site Number : 8400002 - Philadelphia
New South Wales
- Investigational Site Number : 0360001 - Wollongong
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2024-10-30 |
| Est. Completion | 2029-05-14 |
| Phase | Phase 1 |
What NCT06630806 shows while recruiting
NCT06630806 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 1 condition, with Plasma Cell Myeloma Refractory appearing as the primary indexed condition, and to 1 intervention - of which SAR446523 is the first listed.
NCT06630806 lists 18 locations in 13 states (Other, Quebec, Arizona).
Frequently Asked Questions
What is clinical trial NCT06630806 about?
NCT06630806 is a clinical study titled "A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma". 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 6 dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommen...
What is the current status of trial NCT06630806?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2024-10-30. Estimated completion is 2029-05-14.
What conditions does trial NCT06630806 study?
This clinical trial studies the following conditions: Plasma Cell Myeloma Refractory.
What interventions are being tested in trial NCT06630806?
The interventions under investigation include: SAR446523 (DRUG).
Who is sponsoring clinical trial NCT06630806?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06630806 being conducted?
This trial has 18 study locations across Arizona, Florida, Minnesota, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06630806's enrollment target sits among peer trials
82 670th of 2000 higher than 1,330 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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