An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced HER2-positive biliary tract cancer

This is an open-label, randomized, multicenter, phase 3 study to investigate the efficacy and safety of zanidatamab plus CisGem with or without a PD-1/L1 inhibitor (physician’s choice of either durvalumab or pembrolizumab, where approved under local regulations) as first-line treatment for participants with HER2-positive, locally advanced unresectable or metastatic BTC, including gallbladder cancer (GBC), intrahepatic cholangiocarcinoma (ICC), and extrahepatic cholangiocarcinoma (ECC).