Brief Summary
This is a Phase I/II, modular, open-label, multicenter, dosethe amount of medication taken escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM.
Intervention / Treatment
- Drug: AZD0305
Principal 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 Oncologythe study, diagnosis and treatment of cancer 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 diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results 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 marrowsoft, spongy tissue found in bones that makes blood cells function assessment at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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 antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses (e.g., daratumumab).