AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma
NCT ID: NCT06106945
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
226 participants
INTERVENTIONAL
2023-12-05
2027-08-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Participants With Multiple Myeloma (MM)
NCT02431208
A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
NCT03989414
MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
NCT03489525
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
NCT06158841
A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)
NCT03439293
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AZD0305 monotherapy
Module 1:
Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be prescribed at specified dose levels.
AZD0305
AZD0305
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD0305
AZD0305
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
1. Serum M-protein level ≥ 0.5 g/dL.
2. Urine M-protein level ≥ 200 mg/24h.
3. 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Duarte, California, United States
Research Site
Irvine, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Fairfax, Virginia, United States
Research Site
Melbourne, , Australia
Research Site
Nedlands, , Australia
Research Site
Hamilton, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Nova Scotia, , Canada
Research Site
Beijing, , China
Research Site
Changsha, , China
Research Site
Guangzhou, , China
Research Site
Shenyang, , China
Research Site
Lille, , France
Research Site
Nantes, , France
Research Site
Essen, , Germany
Research Site
Freiburg im Breisgau, , Germany
Research Site
Hamburg, , Germany
Research Site
Heidelberg, , Germany
Research Site
Lübeck, , Germany
Research Site
Nuremberg, , Germany
Research Site
Tübingen, , Germany
Research Site
Würzburg, , Germany
Research Site
Kashiwa, , Japan
Research Site
Nagoya, , Japan
Research Site
Yamagata, , Japan
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Pamplona, , Spain
Research Site
Salamanca, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D7230C00001
Identifier Type: -
Identifier Source: org_study_id
2023-508590-89-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.