| Title |
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 |
| Protocole ID |
TED18162 |
| ClinicalTrials.gov ID |
NCT06630806 |
| Cancer Type(s) |
Myeloma |
| Phase |
Phase I |
| Stage |
Relapse/refractory (2nd line and more) |
| Study Type |
Clinical |
| Drug |
SAR446523 |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| City |
|
| Principal Investigator |
Dr. Chaim Shustik
Dr. Michael Sebag
|
| Coordinator |
Nancy Renouf
514-934-1934 poste 35718
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility Criteria |
- Participants with a documented diagnosis of multiple myeloma (MM) with measurable disease.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Dose escalation (Part A) -Participants must have received at least 3 prior lines of antimyeloma therapy which must include a second or third generation immunomodulator, proteosome inhibitor (PI), and anti CD38 monoclonal antibody (mAb) administered with the same or different line.
AND
- Must be either relapsed or refractory to the above therapies, or are intolerant to them, based up on the Investigator's judgment.
- Note: In Part A, prior exposure to anti g-protein-coupled receptor, class c, group 5, member d (GPRC5D) therapy and anti B-cell maturation antigen (BCMA) therapy is allowed.
Dose optimization (Part B)
- Participants must have received at least 3 prior lines of antimyeloma therapy which must include a second or third generation immunomodulator, PI, anti-CD38 mAb, and anti-B Cell Maturation Antigen (anti-BCMA) agent. AND
- Must be either relapsed or refractory to the above therapies, or are intolerant to them, based up on the Investigator's judgment.
- Note: In Part B, prior exposure to antiGPRC5D therapy is not allowed.
|
| Exclusion Criteria |
Participants are excluded from the study if any of the following criteria apply: Eastern cooperative oncology group performance status (ECOG PS) of 2 or greater.
- Primary systemic and localized amyloid light chain (AL) amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, active plasma cell leukemia.
- Systemic antimyeloma treatment within 14 days before the first study treatment administration.
- Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonal antibody with antibody-dependent cellular cytotoxicity as primary mechanism of action) within 90 days of the first study treatment administration.
- Inadequate organ and marrow function.
- Participants with significant concomitant illness.
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
|
| |
|
Groupe d'étude en oncologie du Québec