Summary
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor
(FGFR) 2 and is being developed to treat participants with FGFR2 mutated
cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of
the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine
plus cisplatin) in first-line treatment of participants with unresectable locally
advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will
be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.