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AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma
Trial Status: active
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.
Inclusion Criteria
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:
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06106945.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Rogel Cancer Center
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
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. This
study will follow a modular protocol design evaluating AZD0305 as monotherapy and in
combination with other anticancer agents.
The study includes dose escalation and dose expansion phases. This study will enroll
subjects with RRMM who received at least 3 prior lines of treatment including at least
one proteasome inhibitor (PI), one immunomodulator (IMiD), and an anti-CD38 antibody.
