TITRE | (EN) 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 |
CLINICAL TRIAL.gov ID | NCT06630806 |
TYPE(S) DE CANCER | Myélome |
PHASE | Phase I |
TYPE D'ÉTUDE | Clinique |
INSTITUTION |
CUSM
1001 boul. Décarie |
VILLE | Montréal |
INVESTIGATEUR(RICE) PRINCIPAL(E) | Chaim Shustik Michael Sebag |
COORDONATEUR(RICE) |
Nancy Renouf nancy.renouf@muhc.mcgill.ca 514-934-1934 poste 35718 |
STATUT | Actif en recrutement |
CRITÈRES D'ÉLIGIBILITÉ | (EN)
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
Dose optimization (Part B)
|
CRITÈRES D'EXCLUSION | (EN) 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.
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial. |