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)
  • 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.
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.

  • 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.