Study Comparing AZD0901 with Other Treatments for Advanced Stomach or Gastroesophageal Cancer with Claudin18.2 Expression

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06346392

Provider View

This clinical trial is testing the effectiveness and safety of a new drug, AZD0901, compared to other treatments chosen by doctors for patients with advanced stomach or gastroesophageal cancer that shows a specific protein called Claudin18.2.

Patient Parameters

Program Overview

The study aims to find out if AZD0901 is a better treatment option than the current therapies chosen by doctors for patients with advanced or metastatic stomach or gastroesophageal cancer that expresses the protein Claudin18.2. It will also evaluate a test that identifies patients who might benefit from AZD0901.

Description

This is a Phase III study conducted at multiple centers worldwide. It is open-label, meaning both the researchers and participants know which treatment is being given. The study will compare the new drug AZD0901 with other treatments chosen by doctors for patients with advanced or metastatic stomach or gastroesophageal cancer that shows the protein Claudin18.2. The study will also assess a test that helps identify patients who might benefit from AZD0901. Participants will be randomly assigned to receive either AZD0901 or the treatment chosen by their doctor. The study will monitor the effectiveness and safety of AZD0901 and how well the test identifies suitable patients.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent.
  • At least 18 years old or the legal age of consent.
  • Diagnosed with advanced or metastatic stomach or gastroesophageal cancer that cannot be removed by surgery.
  • Cancer must show the protein Claudin18.2, confirmed by a recent tumor sample.
  • Must have had HER2 testing.
  • Cancer must have worsened after at least one previous treatment that included specific chemotherapy drugs.
  • Must have at least one tumor that can be measured.
  • Good overall health with a performance status of 0 or 1.
  • Expected to live at least 12 more weeks.
  • Adequate organ and bone marrow function.
  • Weigh at least 35 kg.
  • Must follow specific contraceptive guidelines.

Exclusion Criteria

  • Known HER2 positive cancer.
  • Significant or unstable stomach bleeding or untreated stomach ulcers.
  • Cancer spread to the brain or other serious brain conditions.
  • Significant eye disease affecting the cornea.
  • Ongoing severe side effects from previous cancer treatments, except hair loss.
  • Previous treatment with certain types of cancer drugs targeting Claudin18.2.

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