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RecruitingLast updated: 22 June 2026

Testing a new drug for multiple myeloma, either on its own or with other treatmentsA Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Multiple Myeloma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

This study is looking at a new medicine called AZD0305 for people with multiple myeloma (MM). The main aim is to understand how safe the treatment is, what side effects it may cause, how the body processes the drug, and how well it works against the cancer.

The study follows a modular protocol design evaluating AZD0305 by itself (monotherapy) and in combination with other anticancer treatments. The protocol may be updated in future to test new doses or new combinations.

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

Conditions

This trial is treating people with multiple myeloma

Eligibility

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

The above is a summary of key criteria, other inclusion criteria details may apply

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

The above is a summary of key criteria, other exclusion criteria details may apply

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific Title

A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Multiple Myeloma

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