We are currently preparing to initiate a global Phase III clinical trial to be conducted under the review of the U.S. FDA. We have named this study “Beacon-BTC” in the hope that it will serve as a beacon of light for patients with biliary tract cancer.

In this study, patients who have received gemcitabine + cisplatin + durvalumab combination therapy and transition to durvalumab monotherapy will be tested to evaluate the efficacy and safety of the combination of durvalumab + nambululat by switching to durvalumab + nambululat combination therapy.

We will evaluate safety, tolerability, pharmacokinetics, etc. in a large-scale Phase I study, which will be the cornerstone of future global development.

FAQs for each clinical trial are provided here. We offer clear explanations of the meaning of previously disclosed information and key trial milestones.