This study was named "Beacon-BTC" in the hope that it would be a "light" for patients with biliary tract cancer.

Based on the results obtained in the phase 2 clinical trial, this study is planned to be strictly enriched with the primary endpoint as overall survival (OS) and target patients.

Specifically, the patient subtype is limited, and the line of treatment is limited to second-line therapy, and patients after third-line therapy are not eligible. In addition, Treatment Beyond Progression (TBP) is applied to ensure that treatment can be continued even after the disease progresses, allowing for longer-term administration. In addition, it is expected that there will be few patients in the United States who will be eligible for surgery, and that many of the eligible patients will be non-surgical cases that have been highly effective in phase 2 clinical trials.

We believe that these strategies, based on the results of the Phase 2 clinical trial, will increase the probability of trial success.

The Beacon-BTC study consists of two parts:

• In Part A, three groups of nanbran latte administration groups with different dosages were compared with four groups (30 patients each) in the Physician's Best Choice (PBC) group for the purpose of dosing and dose setting.
• In Part B, two groups (180 cases each) were compared between the Nanbulan lat group and the PBC group at the dosage doses selected in PartA.