Study on AZD3470, a PRMT5 Inhibitor, for Patients with Advanced or Metastatic Solid Tumors Lacking MTAP

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06130553

Provider View

This clinical trial is testing a new drug, AZD3470, to see if it is safe and effective for treating advanced or metastatic solid tumors that lack a specific gene called MTAP. The study will explore how well the drug works alone or with other cancer treatments.

Patient Parameters

Program Overview

This study is the first time AZD3470 is being tested in humans. It involves patients with advanced or metastatic solid tumors that are missing the MTAP gene. The study will take place at multiple locations and will assess the safety, how the body processes the drug, and its initial effectiveness. The study is divided into different parts, starting with finding the right dose and then expanding to see how well it works. Future parts may include testing AZD3470 with other cancer drugs.

Description

This clinical trial is designed to test AZD3470, a new drug, in patients with advanced or metastatic solid tumors that lack the MTAP gene. The study is open-label, meaning both the researchers and participants know what treatment is being given. It will take place at several centers and is divided into different modules. The first module will focus on finding the right dose and understanding how the drug interacts with other medications. Later, the study will expand to see how effective the drug is. New parts of the study may be added in the future to test AZD3470 in combination with other cancer treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Willing to provide a tumor sample for testing.
  • Have tried standard treatments for their cancer type and either did not respond, stopped responding, or could not tolerate them.
  • Tumors must lack the MTAP gene or not express it.
  • Be in good general health with a performance status of 0 or 1.
  • Expected to live at least 12 more weeks.
  • Have at least one tumor that can be measured.
  • Have good organ and bone marrow function.
  • Use contraception as required by local regulations during the study.

Exclusion Criteria

  • Have spinal cord compression or unstable brain tumors.
  • Have had an organ transplant.
  • Have severe or uncontrolled medical conditions.
  • Have certain heart conditions, such as low heart function, recent heart attack, or uncontrolled high blood pressure.
  • Have active hepatitis B or C, or HIV.
  • Have lung conditions that required steroids or oxygen.
  • Have digestive issues that affect taking oral medication.
  • Have another type of cancer.
  • Have unresolved side effects from previous cancer treatments, except hair loss or nerve damage.
  • Have previously taken a PRMT5 inhibitor.

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