Trials in Setup

These are brief descriptions of trials currently in set up.  Information will be updated as soon as details are finalised, centres are known and the trials are starting.

DESTINY BTC-01

This is 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.

Study Overview: AstraZeneca is conducting this Phase 3 international clinical trial to evaluate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig compared to the standard-of-care (SoC) treatment in patients with advanced HER2-expressing biliary tract cancer. This study aims to provide a new first-line treatment option for this patient group, potentially improving outcomes where current therapies are limited.

Intervention/Treatment: The study will test two experimental interventions: Trastuzumab Deruxtecan (T-DXd) combined with Rilvegostomig, and T-DXd monotherapy. These are compared against the standard treatment of Gemcitabine, Cisplatin, and Durvalumab, aiming to enhance treatment efficacy for HER2-expressing biliary tract cancer.

July 2025: This international study will be opening in a number of UK locations (Dundee, Glasgow, London, Leeds, Birmingham), and also across Europe. We will share further details as soon as they are available.

For further information, go to: https://clinicaltrials.gov/study/NCT06467357

And: https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=56154