Study on AZD3632 Alone or with Other Cancer Drugs for Advanced Blood Cancers with Specific Genetic Changes

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07155226

Provider View

This clinical trial is testing a new oral medication, AZD3632, to see if it is safe and effective for people with advanced blood cancers that have certain genetic changes. The study will also look at how the drug works in the body and its effects when used alone or with other cancer treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of a new oral drug called AZD3632 in people with advanced blood cancers that have specific genetic changes, such as KMT2Ar or NPM1m, which are linked to high levels of HOX genes. The study will also explore how the drug behaves in the body and its effects when taken alone or with other cancer drugs.

Description

This is the first study in humans to test AZD3632, an oral medication, in people with advanced blood cancers like acute leukemia or myelodysplastic syndromes (MDS) that have certain genetic changes. The study is open-label, meaning both the researchers and participants know what treatment is being given, and it takes place at multiple centers.

The study has two parts:

  • Module 1: This part will test different doses of AZD3632 when used alone to find the best dose.
  • Module 2: This part will test the safety and effects of AZD3632 when used with another drug called posaconazole.

Eligibility Criteria

Inclusion Criteria

  • Have good organ function.
  • Use birth control as required by local regulations.

Module 1:

  • Have advanced blood cancer, such as acute leukemia or MDS, with specific genetic changes linked to high HOX gene levels.
  • Have cancer that has returned or not responded to standard treatments, with no other approved treatment options available.
  • Have a white blood cell count below 25,000/μL.
  • Be in good general health with a performance status score of 2 or less.
  • Have a life expectancy of at least 8 weeks.

Module 2:

  • Have cancer that has returned or not responded to standard treatments, with no other approved treatment options available.
  • Have a white blood cell count below 25,000/μL.
  • Be in good general health with a performance status score of 2 or less.
  • Have a life expectancy of at least 8 weeks.

Exclusion Criteria

  • Have Burkitt lymphoma/leukemia or Acute Promyelocytic Leukemia.
  • Have active cancer in the testicles or central nervous system.
  • Have unresolved side effects from previous treatments that are moderate or severe.
  • Have abnormal potassium or magnesium levels before starting AZD3632.

Module 1:

  • Have received radiation therapy recently.
  • Have taken other cancer drugs or menin inhibitors recently.
  • Have diabetes (Type I or Type II) if participating in the food effect part of the study.

Module 2:

  • Have taken other cancer drugs or received radiation therapy recently.
  • Cannot take posaconazole due to local prescribing information.

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