{"entity":{"id":"first-308","kind":"trial","name":"FIRST-308","aka":[],"tldr":"The first phase 3 trial for patients whose bile duct cancer has outgrown the existing FGFR drugs.","summary":"FIRST-308, sponsored by TransThera, is the first phase 3 trial for patients whose bile duct cancer has outgrown the existing FGFR drugs, testing tinengotinib against FOLFOX or FOLFIRI chemotherapy in FGFR-altered cholangiocarcinoma refractory to chemotherapy and a first-generation FGFR inhibitor. It is a global randomised trial with progression-free survival as the primary endpoint, and the first US patient was dosed in 2025. OnCo links it to biliary tract cancer, FGFR2 as a target and tinengotinib. Whether a next-generation inhibitor active against kinase-domain resistance mutations can beat chemotherapy in patients who have already progressed on targeted therapy is the question it exists to answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"TransThera announcement","url":"https://www.biospace.com/transthera-announces-the-global-multicenter-phase-3-clinical-trial-completed-first-patient-dosing-in-the-us-evaluating-tinengotinib-in-fgfri-relapsed-refractory-patients-with-cholangiocarcinoma"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["fgfr2"],"drugs":["tinengotinib"],"companies":["transthera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"FGFR-altered cholangiocarcinoma refractory to chemotherapy and a first-generation FGFR inhibitor: tinengotinib vs FOLFOX/FOLFIRI","sponsor":"TransThera","enrolledBasis":"registry","outcomes":[]},"route":"/trials/first-308/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"}],"drug":[{"id":"tinengotinib","kind":"drug","name":"Tinengotinib","route":"/drugs/tinengotinib/"}],"company":[{"id":"transthera","kind":"company","name":"TransThera Sciences","route":"/companies/transthera/"}],"idea":[{"id":"idea-btc-ctdna-fgfr-resistance","kind":"idea","name":"ctDNA-guided switching among FGFR inhibitors","route":"/ideas/idea-btc-ctdna-fgfr-resistance/"}]}}