58Beacon-BTC: A Phase 3 Randomized Study Evaluating Nanvuranlat in Patients with Previously Treated Advanced Biliary Tract Cancer
Eric K Rowinsky, Ghassan K Abou-Alfa, Masafumi Ikeda, Makoto Ueno, Milind Javle, Junji FuruseAbstract
Background & Objectives
Patients with advanced biliary tract cancers (BTC) do not have adequate second-line therapy options. Nanvuranlat, a selective inhibitor of L-type amino acid transporter 1 (LATI; SLC7A5), improved progression-free survival in a Phase 2 study in heavily-pretreated patients with drug-refractory BTC. This Phase 3 study will evaluate the efficacy and safety of nanvuranlat for previously treated patients with advanced BTC.
Method
This is a Phase 3, multicenter, randomized, open-label study to evaluate the efficacy and safety of nanvuranlat versus physicians' best choice (PBC) of standard-of-care regimens in patients with advanced BTC who have received one prior BTC therapy. In Part A, 120 patients will be randomized 1:1:1:1 to receive 1 of3 nanvuranlat intravenous infusion regimens (50 or 75 mg via 90-minute infusion once daily for 5 days followed by 9 treatment-free days, or 375 mg via 46-hour continuous infusion once every 14 days) or PBC. Efficacy, safety, and pharmacokinetic data obtained from Part A will be used to select the optimal nanvuranlat regimen for Part B. In Part B, 360 patients will be randomized 1:1 to receive nanvuranlat or PBC. The primary outcome is overall survival, and key secondary outcomes include progression-free survival, objective response rate, and safety measures.
Results
This study is in progress and results are not yet available.
Conclusion
This study will provide robust evaluation of the effectiveness and safety of nanvuranlat compared with standard-of-care therapy for patients with advanced BTC in the second-line treatment setting. This study is underway and patient recruitment was initiated on 19 January 2026.