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Evaluating AZD0305 for treating relapsed/refractory multiple myeloma

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

Phase1; Phase2 Interventional AstraZeneca · NCT06106945

This study is testing a new drug called AZD0305 to see if it can help people with relapsed or refractory multiple myeloma who have already tried several other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment226 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionselranatamab
Locations40 sites (Duarte, California and 39 other locations)
Trial IDNCT06106945 on ClinicalTrials.gov

What this trial studies

This Phase I/II clinical trial is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in patients with relapsed/refractory multiple myeloma (RRMM). The study employs a modular protocol that includes both monotherapy and combination therapy with other anticancer agents. Participants must have received at least three prior lines of treatment, including specific types of therapies, and will be enrolled in dose escalation and expansion phases to determine optimal dosing. The trial is multicenter and open-label, allowing for a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of multiple myeloma who have undergone at least three prior lines of treatment.

Not a fit: Patients who have not received the required prior treatments or have a performance status greater than 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat relapsed/refractory multiple myeloma.

How similar studies have performed: Other studies have shown promise with similar approaches targeting multiple myeloma, but the specific use of AZD0305 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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

Where this trial is running

Duarte, California and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaGPRC5DADCAZD0305MMMMAE
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.