• Mairéad Geraldine McNamara, Lipika Goyal, Mark Doherty, Christoph Springfeld, David Cosgrove, Katrin Marie Sjoquist, Joon Oh Park, Helena Verdaguer, Chiara Braconi, Paul J Ross, GramontAimery DeADepartment of Medical Oncology, Franco-British Institute, Levallois-Perret, France., John Raymond Zalcberg, Daniel H Palmer, Juan W Valle, and Jennifer J Knox.
• Division of Cancer Sciences, The University of Manchester & The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.
• Future Oncol. 2020 Jun 1; 16 (16): 1069-1081.

AbstractGemcitabine/cisplatin is standard of care for first-line treatment of patients with advanced biliary tract cancer (aBTC); new treatments are needed. NUC-1031 is designed to overcome key cancer resistance mechanisms associated with gemcitabine. The tolerability/efficacy signal of NUC-1031/cisplatin in the Phase Ib ABC-08 study suggested that this combination may represent a more efficacious therapy than gemcitabine/cisplatin for patients with aBTC, leading to initiation of the global NuTide:121 study which will include 828 patients ≥18 years with untreated histologically/cytologically-confirmed aBTC (including cholangiocarcinoma, gallbladder or ampullary cancer); randomized (1:1) to NUC-1031 (725 mg/m2)/cisplatin (25 mg/m2) or gemcitabine (1000 mg/m2)/cisplatin (25 mg/m2), on days 1/8, Q21-days. Primary objectives are overall survival and objective response rate. Secondary objectives: progression-free survival, safety, pharmacokinetics, patient-reported quality of life and correlative studies. (Investigational new drug (IND) number: 139058, European Clinical Trials database: EudraCT Number 2019-001025-28, ClinicalTrials.gov identifier: NCT04163900).

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