Myélome

TITRE (EN) A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Lmmunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Relapsed or Refractory Multiple Myeloma
PROTOCOLE ID D7230C00001
CLINICAL TRIAL.gov ID NCT06106945
TYPE(S) DE CANCER Myélome
PHASE Phase I-II
TYPE D'ÉTUDE Clinique
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
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)
  • Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
  • Eastern Cooperative Oncology group (ECOG) performance status of ≤ 2.
  • Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria.

  • Participants must have one or more of the following measurable disease criteria:

    • Serum M-protein level ≥ 0.5 g/dL.
    • Urine M-protein level ≥ 200 mg/24h.
    • Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
  • Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP.
  • Participants must have received at least 3 prior lines of treatment which include a proteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide), and an anti-CD38 antibody (e.g., daratumumab).
CRITÈRES D'EXCLUSION (EN)
  • Participants exhibiting clinical signs of central nervous system involvement of MM.
  • Participants with known COPD, or previous history of ILD.
  • Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification.
  • Participants who have severe cardiovascular disease which is not adequately controlled.
  • Participants who have a history of immunodeficiency disease.
  • Participants with peripheral neuropathy ≥ Grade 2.
  • Primary refractory MM.
  • Participants who have previously received anti-GPRC5D or MMAE-containing treatment.
  • Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention.