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A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants with Multiple Myeloma

Primary Investigator
Pianko, Matthew
Status
OPEN TO ACCRUAL
Phase
I
II
NCT Number
NCT06106945
UM Number
2024.048
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Hematological Malignancies
ID (Protocol)
49395
Secondary Protocol No
HUM00252207
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Multiple Myeloma
Summary
This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM.

Eligibility: Inclusion Criteria
  •   Principal
  •   * 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:
  •    1. Serum M-protein level >= 0.5 g/dL.
  •    2. Urine M-protein level >= 200 mg/24h.
  •    3. 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).
  •   Principal
Exclusion Criteria
  •   * 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.