Study on AZD0305 Alone or with Other Cancer Drugs for Treating Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06106945

This clinical trial is testing a new drug, AZD0305, either by itself or combined with other cancer treatments, to see if it is safe and effective for patients with multiple myeloma that has returned or is not responding to previous treatments.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a new drug called AZD0305 for patients with relapsed or refractory multiple myeloma (RRMM). The trial will test AZD0305 both on its own and in combination with other cancer drugs. It will involve different phases to find the best dose and to see how well the drug works in controlling the disease.

Description

This clinical trial is designed to evaluate a new treatment, AZD0305, for patients with multiple myeloma that has come back or is not responding to previous treatments. The study will test AZD0305 alone and in combination with other cancer drugs to determine its safety, how well it is tolerated, and its effectiveness in reducing cancer symptoms.

The trial will be conducted in multiple centers and will include different phases to find the right dose and to see how the drug affects the body. Participants will receive AZD0305 through an IV (intravenous) infusion. The study will include patients who have already tried at least three different treatments, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 2 or less, meaning fully active or able to do light work.
  • Have a confirmed diagnosis of multiple myeloma according to specific medical criteria.
  • Have measurable disease based on certain blood or urine tests.
  • Have adequate organ and bone marrow function based on specific medical tests.
  • Have received at least three prior treatments, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody.

Exclusion Criteria

  • Have signs of multiple myeloma affecting the brain or spinal cord.
  • Have chronic obstructive pulmonary disease (COPD) or a history of lung disease.
  • Have moderate or severe asthma in the past five years, or uncontrolled asthma.
  • Have severe heart disease that is not well managed.
  • Have a history of immune system disorders.
  • Have nerve damage of grade 2 or higher.
  • Have primary refractory multiple myeloma, meaning it did not respond to initial treatment.
  • Have previously received treatments targeting GPRC5D or containing MMAE.
  • Have had an allogeneic stem cell transplant, or an autologous stem cell transplant within the last three months.

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