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 |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
3001 12e Avenue Nord (819) 346-1110 |
VILLE | Sherbrooke |
INVESTIGATEUR(RICE) PRINCIPAL(E) | Michel Pavic |
COORDONATEUR(RICE) |
Christine Lawson christine.lawson.ciussse-chus@ssss.gouv.qc.ca 819-346-1110 poste 12942 |
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)
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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. |