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 1 study, which will be the cornerstone of future global development.