Study on the Safety and Effectiveness of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04379596

Provider View

This clinical trial is exploring the safety and effectiveness of a drug called trastuzumab deruxtecan (T-DXd), used alone or with other treatments, for patients with advanced gastric or gastroesophageal cancer that shows HER2 protein.

Patient Parameters

Program Overview

The DESTINY-Gastric03 study is testing a drug called trastuzumab deruxtecan (T-DXd) to see if it is safe and effective for treating advanced gastric, gastroesophageal junction (GEJ), and esophageal cancers that express the HER2 protein. The study will look at how well T-DXd works on its own and when combined with chemotherapy or immunotherapy. Researchers hope to find out if these combinations can help control the cancer and if they are safe enough for further testing. The study is focused on patients who have not received treatment for their advanced cancer or have progressed after previous treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced or metastatic cancer of the stomach, GEJ, or esophagus that cannot be removed by surgery.
  • For certain parts of the study, the cancer must be HER2-positive, meaning it shows a high level of the HER2 protein.
  • For other parts, the cancer can be HER2-low, showing a lower level of HER2 protein.
  • Must have measurable cancer that can be tracked by scans.
  • Must have good bone marrow and organ function, including heart, kidney, and liver health.
  • If able to have children, must agree to use effective birth control during the study.

Exclusion Criteria

  • Have a history of immune system problems, HIV, or active hepatitis B or C infections.
  • Have uncontrolled health issues.
  • Have a history of lung inflammation or current lung disease that cannot be ruled out by scans.
  • Have severe lung-related illnesses.
  • Have an uncontrolled infection needing IV treatment.
  • Have fluid buildup around the lungs, heart, or abdomen that needs draining.
  • Have spinal cord compression or active cancer spread to the brain.

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