Destiny-Biliary Tract Cancer 01
Research type
Research Study
Full title
DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer
IRAS ID
1011380
Contact name
Juliet Wou
Contact email
Sponsor organisation
Astrazeneca AB
Clinicaltrials.gov Identifier
Research summary
Even though there have been improvements in initial treatments for people with biliary tract cancer (BTC), there's still a chance to achieve better results than what we've seen with current chemotherapy and immunotherapy options.
The purpose of this study is to explore if the investigational drug trastuzumab deruxtecan (also known as T-DXd, DS-8201a) alone or in combination with rilvegostomig compared to standard of care treatment with gemcitabine, cisplatin, and durvalumab is effective in treating patients for first line locally advanced or metastatic Human epidermal growth factor receptor 2 HER2-expressing biliary tract cancer. Locally advanced or metastatic BTC is a devastating disease with 5-year survival rates < 5% (American Cancer Society). The study will also allow us to better understand the studied disease and associated health problems.
Trastuzumab deruxtecan (T-DXd, DS-8201a) is a type of anti-cancer drug called an ‘antibody drug conjugate’ (ADC) that targets cancer cells. One part of this drug is a protein called a monoclonal antibody (trastuzumab) that recognizes and attaches to cells that have a specific protein called HER2 on their surface. Another part of this drug contains a chemotherapy-like molecule called deruxtecan, or DXd. When T-DXd binds to a HER2 protein on a cancer cell, the DXd molecule is released into the cancer cell, damaging or killing it. We are doing this study to learn more about how trastuzumab deruxtecan might provide benefit to patients with cancer.
Rilvegostomig (AZD2936), is a new type of anti-cancer drug called a monoclonal antibody that may help your immune system fight your cancer. It blocks signalling from two proteins called PD-1 and TIGIT on cells of your immune system at the same time. Cancer cells use PD-1 and TIGIT to avoid being attacked by the immune system so they can grow and survive. By stopping cancer cells from using these molecules, rilvegostomig may help your immune system find and attack cancer cells.REC name
South West - Central Bristol Research Ethics Committee
REC reference
25/SW/0018
Date of REC Opinion
6 May 2025
REC opinion
Further Information Favourable Opinion