RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-05
Study Completion:2025-11-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06106945

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Eastern Cooperative Oncology group (ECOG) performance status of ≤ 2.
  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.
  4. * Participants must have one or more of the following measurable disease criteria:
  5. 1. Serum M-protein level ≥ 0.5 g/dL.
  6. 2. Urine M-protein level ≥ 200 mg/24h.
  7. 3. Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
  8. * Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP.
  9. * 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).
  1. * Participants exhibiting clinical signs of central nervous system involvement of MM.
  2. * Participants with known COPD, or previous history of ILD.
  3. * Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification.
  4. * Participants who have severe cardiovascular disease which is not adequately controlled.
  5. * Participants who have a history of immunodeficiency disease.
  6. * Participants with peripheral neuropathy ≥ Grade 2.
  7. * Primary refractory MM.
  8. * Participants who have previously received anti-GPRC5D or MMAE-containing treatment.
  9. * 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.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Duarte, California, 91010
United States
Research Site
Irvine, California, 92618
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
New York, New York, 10065
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05
Study Completion Date2025-11-11

Study Record Updates

Study Start Date2023-12-05
Study Completion Date2025-11-11

Terms related to this study

Keywords Provided by Researchers

  • GPRC5D
  • ADC
  • AZD0305
  • Relapsed Refractory Multiple Myeloma
  • RRMM
  • MMAE

Additional Relevant MeSH Terms

  • Multiple Myeloma