# Tinengotinib

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

## TL;DR

A next-generation FGFR inhibitor designed to work after pemigatinib or futibatinib stop working, now in a global phase 3.

## Summary

Tinengotinib is a type I multi-kinase inhibitor active against FGFR1-3, including the FGFR2 kinase-domain resistance mutations (N550, V565) that emerge after pemigatinib or futibatinib, plus VEGFR, Aurora and JAK kinases. It is aimed at FGFR-altered cholangiocarcinoma that has progressed on a prior FGFR inhibitor, a group with no approved targeted option. A phase 1/2 study in heavily pretreated patients, including after prior FGFR inhibitors, showed disease control with median PFS of about 5 to 6 months. The global phase 3 FIRST-308 trial randomises FGFR inhibitor-refractory patients to tinengotinib versus FOLFOX or FOLFIRI, primary endpoint PFS; the first US patient was dosed in 2025. Whether its broad kinase profile adds toxicity without benefit over selective FGFR2 inhibitors is open. For a newcomer, it is a drug for bile duct cancer that has outgrown the existing FGFR pills.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-07
- Code: TT-00420
- Modality: Small-molecule multi-kinase inhibitor (FGFR1-3, VEGFR, Aurora, JAK)
- Mechanism: Type I inhibitor active against FGFR2 kinase-domain resistance mutations (N550, V565) plus VEGFR and Aurora kinases.

## Sources

- ClinicalTrials.gov NCT05948475: tinengotinib versus physician's choice in FGFR-altered cholangiocarcinoma (phase 3): https://clinicaltrials.gov/study/NCT05948475
- ClinicalTrials.gov NCT05253053: TT-00420 (tinengotinib) monotherapy and combinations (phase 1/2): https://clinicaltrials.gov/study/NCT05253053

## 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/)
- companies: [TransThera Sciences](https://onco.cc/companies/transthera/)
- terms: [FGFR2 fusions and rearrangements](https://onco.cc/terms/fgfr2-fusion/)
- trials: [A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.](https://onco.cc/trials/nct07052253/), [Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment](https://onco.cc/trials/nct07498478/), [FIRST-308](https://onco.cc/trials/first-308/), [Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma](https://onco.cc/trials/nct05948475/)
- ideas: [ctDNA-guided switching among FGFR inhibitors](https://onco.cc/ideas/idea-btc-ctdna-fgfr-resistance/)

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