AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma
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 preliminary efficacy of AZD0305 in participants with RRMM.
Objectives
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.
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 (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:
- 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 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
Treatment Sites in Georgia
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