RecruitingPhase 1Phase 2NCT06106945

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

Sponsor

AstraZeneca

Enrollment

226 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called AZD0305 — either alone or combined with other cancer drugs — in patients with multiple myeloma (a blood cancer of plasma cells) that has returned or stopped responding after multiple prior treatments. AZD0305 targets a protein called GPRC5D found on myeloma cells. **You may be eligible if...** - You are 18 or older with confirmed multiple myeloma - You have measurable disease (detectable myeloma proteins in blood or urine) - You have received at least 3 prior lines of treatment including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody (e.g., bortezomib, lenalidomide, daratumumab) - Your general health is adequate (ECOG ≤ 2) **You may NOT be eligible if...** - Your myeloma has spread to the brain or spinal cord - You have COPD, interstitial lung disease, or severe uncontrolled asthma - You have severe cardiovascular disease - You have a history of immune deficiency - You have significant nerve damage (peripheral neuropathy grade 2 or worse) - Your myeloma never responded to any prior treatment (primary refractory) - You have previously received anti-GPRC5D therapy or treatments containing MMAE - You had an allogeneic stem cell transplant, or autologous transplant within the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD0305

AZD0305 Investigational product

DRUGElranatamab

Module 2 Investigational product

DRUGPomalidomide

Module 3 Standard of Care (background treatment)

DRUGDexamethasone

Module 3 Standard of Care (background treatment)

Locations(40)

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

Fitzroy, Australia

Research Site

Melbourne, Australia

Research Site

Nedlands, Australia

Research Site

Wollongong, Australia

Research Site

Hamilton, Ontario, Canada

Research Site

Ottawa, Ontario, Canada

Research Site

Toronto, 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

Badalona, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Pamplona, Spain

Research Site

Salamanca, Spain

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NCT06106945

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