AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

Description

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 preliminary efficacy of AZD0305 in participants with RRMM.

Conditions

Multiple Myeloma

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Study Overview

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Study Details

Study overview

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 preliminary efficacy of AZD0305 in participants with RRMM.

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

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Duarte

Research Site, Duarte, California, United States, 91010

Irvine

Research Site, Irvine, California, United States, 92618

Atlanta

Research Site, Atlanta, Georgia, United States, 30322

Boston

Research Site, Boston, Massachusetts, United States, 02215

Ann Arbor

Research Site, Ann Arbor, Michigan, United States, 48109

Saint Louis

Research Site, Saint Louis, Missouri, United States, 63110

New York

Research Site, New York, New York, United States, 10065

Philadelphia

Research Site, Philadelphia, Pennsylvania, United States, 19104

Fairfax

Research Site, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 (ECOG) performance status of ≤ 2.
  • * 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 of the following measurable disease criteria:
  • 1. Serum M-protein level ≥ 0.5 g/dL.
  • 2. Urine M-protein level ≥ 200 mg/24h.
  • 3. Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
  • * Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP.
  • * Participants must have received at least 3 prior lines of treatment which include a proteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide), and an anti-CD38 antibody (e.g., daratumumab).
  • * Participants exhibiting clinical signs of central nervous system involvement of MM.
  • * Participants with known COPD, or previous history of ILD.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2025-11-11