Study of AZD9574 Alone and with Other Cancer Treatments in Patients with Advanced Cancers

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05417594

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, AZD9574, both by itself and combined with other cancer treatments, in patients with advanced cancers that have returned or worsened.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective AZD9574 is when used alone or with other cancer drugs in patients with advanced cancers that have come back or progressed. It will involve about 490 participants and will be conducted in multiple parts, each focusing on different aspects of the treatment.

Description

This study is divided into several parts, each testing different aspects of the drug AZD9574:

  • Module 1 (AZD9574 alone):

    • Part A: Tests different doses in 130 patients with advanced ovarian, breast, pancreatic, or prostate cancer.
    • Part B: Expands to include more patients with specific types of breast cancer.

  • Module 2 (AZD9574 with Temozolomide):

    • Tests the combination in 75 patients with a specific type of brain tumor.

  • Module 3 (PET Sub-study):

    • Conducted in Sweden, involves a small number of patients to study how the drug behaves in the body.

  • Module 4 (AZD9574 with Trastuzumab deruxtecan):

    • Tests the combination in 90 patients with HER2-positive cancers.

  • Module 5 (AZD9574 with Datopotamab deruxtecan):

    • Tests the combination in 90 patients with various advanced cancers.

Each module will assess the safety and tolerability of the treatments, and some will explore how well the treatments work in shrinking tumors.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced cancer that has progressed.
  • Must be in good general health with adequate organ function.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test.
  • Men must use condoms and avoid fathering a child during and after the study.
  • Specific criteria apply to each module, such as having certain genetic mutations or types of cancer.

Exclusion Criteria

  • Recent major surgery or radiation therapy.
  • Unresolved side effects from previous treatments.
  • Certain medical conditions like severe infections or uncontrolled illnesses.
  • History of severe allergic reactions to similar drugs.
  • Specific criteria apply to each module, such as previous treatments or certain health conditions.

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