A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib vs Physicians Choice in Subjects with FGFR-Altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma

The main purpose of this study is to learn how well tinengotinib works and the safety of tinengotinib compared with the study doctor’s choice of chemotherapy treatment. The purpose of Part A of the study will be to determine the best dose of tinengotinib to use in Part B of the study. The purpose of Part B is to learn more about how well tinengotinib works and its safety compared with the study doctor’s choice of treatment. From here on, tinengotinib will be referred to as the “study drug”.