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Taking people in GermanyPhase 1/2

Tests AZD0305 alone or with other cancer drugs in multiple myeloma

Tests the drug AZD0305, alone or combined, in adults with multiple myeloma.

Key facts

Who runs it
AstraZeneca
Where
Essen, Freiburg im Breisgau, Hamburg, Heidelberg, Lübeck, Nuremberg, Tübingen, and Würzburg, GermanySee the 8 sitesAlso in 9 other countries, 36 sites
Registry title
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Status
Recruiting
Phase
Phase 1/2
People taking part
226 people, planned
Started
5 Dec 2023
Expected to end
24 Jan 2028
Type of study
Interventional, 3 groups
Treatments tested
  • AZD0305
  • Elranatamab
  • Pomalidomide
  • Dexamethasone
Record updated
30 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with multiple myeloma who have measurable disease. In the first part, they must have had at least 3 earlier lines of treatment.

Age
At least 18 years old, or the legal age of consent where the study takes place.
Sex
Men and women can both join.
Disease stage
Multiple myeloma confirmed by the IMWG diagnostic criteria, with measurable disease (serum M-protein, urine M-protein or serum free light chains).
Earlier treatment
In module 1, at least 3 earlier lines of treatment. In modules 2 and 3, the number of earlier lines depends on the study phase. Earlier anti-GPRC5D or MMAE-containing treatment is not allowed.

Main reasons for not taking part

  • Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, POEMS syndrome or smoldering multiple myeloma
  • Earlier anti-GPRC5D or MMAE-containing treatment
  • Allogenic stem cell transplant, or autologous stem cell transplant within 3 months before the first dose
  • Signs of multiple myeloma in the central nervous system
  • Peripheral neuropathy of Grade 2 or higher, or primary refractory multiple myeloma

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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. In modules 2 and 3, participants must meet the phase-specific requirements for the number of prior lines of therapy
  • The above is a summary of key criteria, other module specific inclusion criteria details may apply

Who cannot take part

  • Participants who have previously received anti-GPRC5D or MMAE-containing treatment
  • Participants with a known hypersensitivity toAZD0305 or any of the excipients of the productor to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior mono clonal antibody therapy
  • Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3months before the first dose of study intervention
  • Participants with known history of severe or very severe COPD, or previous history of non-infectious ILD/pneumonitis that has required oral or IV steroids of supplemental oxygen, or where suspected suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma(compliant with WHO criteria)
  • 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 John Cunningham virus infection resulting in PML
  • Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration
  • Participants who have severe cardio vascular disease which is not adequately controlled
  • Participants who have a history of immunodeficiency disease
  • Participants exhibiting clinical signs of central nervous system involvement of MM
  • Participants with known severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification
  • Participants with peripheral neuropathy ≥ Grade2
  • Primary refractory MM
  • The above is a summary of key criteria, other exclusion criteria details may apply

Where in Germany

Also in 9 other countries, 36 sites

  • EssenHospital not named in the registryTaking people
  • Freiburg im BreisgauHospital not named in the registryNo longer taking part
  • HamburgHospital not named in the registryTaking people
  • HeidelbergHospital not named in the registryNot yet recruiting
  • LübeckHospital not named in the registryTaking people
  • NurembergHospital not named in the registryTaking people
  • TübingenHospital not named in the registryNot yet recruiting
  • WürzburgHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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 efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.

The 3 groups in the trial

  • AZD0305 monotherapyTreatment being tested

    Module 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be administered at specified dose levels.

    Treatment: AZD0305

  • AZD0305 + ElranatamabTreatment being tested

    Module2: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with elranatamab, following the module-specific dosing.

    Treatment: AZD0305 and Elranatamab

  • AZD0305 + Pomalidomide and DexamethasoneTreatment being tested

    Module3: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with pomalidomide and dexamethasone, following the module-specific dosing.

    Treatment: AZD0305, Pomalidomide, and Dexamethasone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Tests AZD0305 alone or with other cancer drugs in multiple myelomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
30 October 2026