A Modular Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy and in Combination With Anticancer Agent(s) in Participants with Relapsed or Refractory Multiple Myeloma - D7230C00001

AstraZeneca AB0 个研究点目标入组 66 人开始时间: 2024年2月6日最近更新: 2024年8月21日

适应症

试验速览

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•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 performance status of = 2., Documentation of Multiple Myeloma (MM) as defined by International Myeloma WorkingGroup (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that MultipleMyeloma 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., Participants must have one or more of the following measurable disease criteria: (b) Urine M-protein level = 200 mg/24h., Participants must have one or more of the following measurable disease criteria: Serum immunoglobulin free light chain = 10 mg/dL and abnormal serum immunoglobulinkappa lambda free light chain ratio., Adequate organ and bone marrow function assessment at screening according to thehematological, hepatic, and renal parameters listed in the CSP., Participants must have received at least 3 prior lines of treatment which include aproteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide), and ananti-CD38 antibody (e.g., daratumumab).

•Amyloidosis, plasma cell leukemia (compliant with WHO criteria)., Participants who have previously received allogenic stem cell transplant, or participant hasreceived autologous stem cell transplant within 3 months before the first dose of studyintervention., 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, oruncontrolled 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.

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