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.

Building on the outcomes of the Phase II clinical trial, this study is designed with overall survival (OS) as the primary endpoint. To maximize the likelihood of demonstrating clinical benefit, we plan to implement strict patient enrichment criteria.

Specifically, the eligible biliary tract cancer subtypes will be aligned with the Western definition—excluding ampullary cancer—and enrollment will be limited to second-line patients, with those receiving third-line or later therapies excluded. In addition, the study incorporates a Treatment Beyond Progression (TBP) approach, allowing treatment to continue even after disease progression, thereby enabling longer-term administration. In the United States, few patients undergo surgical resection, and thus the majority of participants are expected to be non-surgical cases, a population shown to derive greater benefit in the Phase II analysis.

By applying these strategies, which build on our Phase II results, we aim to increase the probability of success in this trial.

The Beacon-BTC study consists of two parts.

• Part A: Four groups (30 patients each) will be compared, including three nanvuranlat groups with different dosing regimens and one Physician’s Best Choice (PBC) group, to determine the optimal dose and regimen.
• Part B: Two groups (180 patients each)—the nanvuranlat group using the dose and regimen selected in Part A and the PBC group—will be compared.

Information on the global Phase III clinical trial (Beacon-BTC) has been registered and made publicly available in the U.S. clinical trial database, ClinicalTrial.gov.