Status:
RECRUITING
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
AstraZeneca
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 prelimina...
Detailed Description
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 prelimina...
Eligibility Criteria
Inclusion
- Principal
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT06106945
Start Date
December 5 2023
End Date
March 15 2027
Last Update
October 16 2025
Active Locations (33)
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1
Research Site
Duarte, California, United States, 91010
2
Research Site
Irvine, California, United States, 92618
3
Research Site
Atlanta, Georgia, United States, 30322
4
Research Site
Boston, Massachusetts, United States, 02215