AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
Plasma cell neoplasm
18 Years and older, Male and Female
D7230C00001 (primary)
NCI-2023-10034
2023-508590-89-00
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 efficacy of AZD0305 as monotherapy and in combination with other
anticancer agents in participants with MM.
Objectives
This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in
combination with other anticancer agents. The protocol may be amended in the future to
incorporate further monotherapy expansion at the recommended Phase 2 dose (RP2D) in Phase
II, and/or additional modules investigating AZD0305 in combination with other anticancer
agents.
The study consists of 3 modules:
- Module 1 (AZD0305 monotherapy),
- Module 2 (AZD0305 in combination with elranatamab)
- Module 3 (AZD0305 in combination with pomalidomide and dexamethasone [Pd])
Eligibility
- 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 in module 1, or 0 or 1 in modules 2 and 3;
- 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 measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;
- Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module;
- Participants must have received at least 3 prior lines of treatment in module 1, or 1-3 prior lines in modules 2 and 3, with additional module-specific requirements related to prior lines of therapy The above is a summary of key criteria, other inclusion criteria details may apply Key
Treatment Sites in Georgia
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