# FIRST-308

Source: https://onco.cc/trials/first-308/  
OnCo record `first-308` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-07
- Phase: 3
- Setting: FGFR-altered cholangiocarcinoma refractory to chemotherapy and a first-generation FGFR inhibitor: tinengotinib vs FOLFOX/FOLFIRI
- Sponsor: TransThera

## Sources

- TransThera announcement: 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

## Connected records

- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [FGFR2](https://onco.cc/targets/fgfr2/)
- drugs: [Tinengotinib](https://onco.cc/drugs/tinengotinib/)
- companies: [TransThera Sciences](https://onco.cc/companies/transthera/)
- ideas: [ctDNA-guided switching among FGFR inhibitors](https://onco.cc/ideas/idea-btc-ctdna-fgfr-resistance/)

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