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AZD0305 for Multiple Myeloma

This study is testing a new drug called AZD0305 for people with multiple myeloma (a type of blood cancer). Researchers want to see how safe AZD0305 is, how well your body handles it, and if it helps treat multiple myeloma. AZD0305 will be given alone or in combination with other anti-cancer drugs like elranatamab, or with pomalidomide and dexamethasone. The main goals are to track any side effects and how often they happen, and if participants need to stop or change their treatment due to side effects. To join, you must be at least 18 years old and have a confirmed diagnosis of multiple myeloma. The study is currently unclear about its recruitment status and plans to enroll 226 participants.

Study design
This is a Phase I/II, open-label study, meaning you and your doctors will know which treatment you are receiving. It is designed in modules, testing AZD0305 alone and in different combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects from the time you give consent until 30 days after your treatment ends. For some parts of the study, monitoring for dose changes or discontinuations due to side effects will continue for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06106945

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~226 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:AZD0305ElranatamabPomalidomideDexamethasone

At a glance

Recruiting sites
32 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)
Measured over From first dose of AZD0305 until the end of Cycle 1. Cycle 1 (the DLT assessment period is 21 days for Module 1 Group A and 28 days for Module 1 Group B, Module 2, and Module 3)
+2 more outcomes measured

Conditions

Multiple Myeloma

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Multiple Myeloma

Where it's being run

43 sites across 18 states
Germany8
Spain5
Australia4
China4
Brazil3
Ontario3
Japan3
California2

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);
Participants exhibiting clinical signs of central nervous system involvement of MM;
Participants with known COPD, or previous history of ILD/pneumonitis;
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;
Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply;
Participants with previous history of active JC virus infection resulting in PML;
Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monoclonal antibody therapy;
Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration

What this trial measures

  • Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)From first dose of AZD0305 until the end of Cycle 1. Cycle 1 (the DLT assessment period is 21 days for Module 1 Group A and 28 days for Module 1 Group B, Module 2, and Module 3)

    A DLT is any toxicity occuring from the first dose of AZD0305 up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes, any death not clearly due to the underlying disease or extraneous causes, pre-defined haematological and non-haematological toxicities

  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)From time of Informed consent to 30 days post end of treatment

    Number of patients with adverse events and serious adverse events by system organ class and preferred term

  • Frequency of dose modifications, dose delays, and treatment discontinuations due to AEs (Module 2 and Module 3)From first dose of study treatment until End of treatment (EOT), assessed up to approximately 2 years (each cycle is 28 days)

    Number and percentage of participants with dose modifications, dose delays, and permanent discontinuations due to adverse events (for AZD0305 and combination agent\[s\], as applicable), per protocol-defined dose modification rules.