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NCT07073547PHASE1Recruiting

A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2)

AstraZeneca

Start Date

7/31/2025

Completion Date

5/26/2028

Summary

This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).

Detailed Description

This modular study aims to evaluate the safety, tolerability, cellular kinetics, pharmacodynamic effect, immunogenicity, and preliminary efficacy of AZD0120 in subjects with newly diagnosed or early relapsed or primary refractory multiple myeloma. Module 1 consists of early line MM (including newly diagnosed MM and early relapsed or primary refractory MM) with AZD0120 (for newly diagnosed multiple myeloma (NDMM), the intervention is with AZD0120 ± maintenance). Module 2 consists of NDMM with AZD0120 ± maintenance.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: Age: * Males and females ≥18 years of age at the time of consent Type of Participant and Disease Characteristics: * Participant must have documented diagnosis of MM per IMWG diagnostic criteria * ECOG performance status of 0 or 1. * Adequate organ and bone marrow function. For NDMM participants: * Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable) * For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening * Classified as high-risk MM For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants: * Have received and failed 1 or 2 lines of anti-myeloma therapy * Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy * Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen General Exclusion Criteria: * Have received prior treatment with CAR T therapy directed at any target * Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma * Active or history of plasma cell leukemia at the time of screening * Seropositive for human immunodeficiency virus (HIV) * Active Hepatitis B infection * Active Hepatitis C infection * Serious underlying medical condition

Interventions

BIOLOGICAL

AZD0120

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Conditions

Multiple Myeloma

Locations

Research Site

Phoenix, Arizona 85054

United States

Research Site

Duarte, California 91010

United States

Research Site

Denver, Colorado 80218

United States

Research Site

Tampa, Florida 33612

United States

Research Site

Atlanta, Georgia 30322

United States

Research Site

Iowa City, Iowa 52242

United States

Research Site

Rochester, Minnesota 55905

United States

Research Site

St Louis, Missouri 63110

United States

Research Site

New York, New York 10016

United States

Research Site

Nashville, Tennessee 37203

United States

Research Site

Dallas, Texas 75235

United States

Research Site

Houston, Texas 77030

United States

Research Site

Charlottesville, Virginia 22903

United States