Phase 3 Study Comparing T-DXd and Rilvegostomig with Standard Treatment in Advanced HER2-expressing Biliary Tract Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06467357

Provider View

This clinical trial is testing the effectiveness and safety of a new treatment using T-DXd with rilvegostomig or T-DXd alone, compared to the standard treatment of gemcitabine, cisplatin, and durvalumab in patients with advanced HER2-expressing biliary tract cancer who have not received prior treatment.

Patient Parameters

Program Overview

The aim of this study is to evaluate how well the new treatment options, T-DXd with rilvegostomig or T-DXd alone, work in comparison to the current standard treatment for patients with advanced biliary tract cancer that expresses the HER2 protein. The study will also assess the safety of these treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older at the time of screening.
  • Both men and women can participate.
  • Have biliary tract cancer that cannot be removed by surgery and has not been treated before, or has spread to other parts of the body. Previous treatment is allowed if it was completed more than 6 months before the cancer spread or became advanced.
  • Cancer must be confirmed to express the HER2 protein.
  • Must provide a tumor sample that is no older than 3 years.
  • Must have at least one tumor that can be measured by scans.
  • Must be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate organ and bone marrow function as shown by tests within 14 days before starting the study.
  • Women of childbearing potential must have a negative pregnancy test or be post-menopausal.

Exclusion Criteria

  • Have previously received treatments targeting HER2, antibody-drug conjugates, immune checkpoint inhibitors, or cancer vaccines.
  • Have a specific type of cancer called ampullary carcinoma.
  • Have a history of substance abuse or significant heart or mental health conditions.
  • Have untreated or symptomatic cancer spread to the brain or spinal cord.
  • Have had a heart attack or serious heart problems within the last 6 months.
  • Have serious digestive conditions causing diarrhea or active skin diseases needing treatment.
  • Have active autoimmune or inflammatory disorders needing treatment in the last 2 years.
  • Have a prolonged QT interval on an ECG test.
  • Have a history of lung inflammation or current lung issues that cannot be ruled out.
  • Have significant lung illnesses or have had a lung removed.
  • Have an uncontrolled infection needing IV treatment.
  • Have an active immune deficiency or uncontrolled HIV or hepatitis C.
  • Are pregnant, breastfeeding, or planning to become pregnant.
  • Are participating in another clinical study with an intervention or device within the last 6 months, unless it is non-interventional.

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