marked.bio

multi-kinase inhibitor (FGFR) · small molecule

tinengotinib

2 active trials across 2 of our biomarkers, targeting FGFR/Aurora/JAK. Not approved for any biomarker on marked.bio yet.

Also known as TT-00420.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
FGFR2 fusion or rearrangement 2 3 Phase 3
FGFR3 alteration (mutation or fusion) 1 2 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of tinengotinib.

  1. TransThera Sciences 2

Trials

2 of 3 trials shown

  1. Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations

    Not yet recruiting Phase 3 TransThera Sciences Started 2026Primary completion 2029-12 NCT07328919

    tinengotiniboxaliplatinfluorouracilleucovorinirinotecancapecitabine

    The presence of FGFR2 gene fusion/rearrangement or mutation must be confirmed by detection using tumor tissue samples provi…

    FGFR2 fusion or rearrangementIntrahepatic Cholangiocarcinoma (Icc), Advanced Cholangiocarcinoma

  2. Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

    Active, not recruiting Phase 3 TransThera Sciences Started 2023Primary completion 2026-12 NCT05948475

    tinengotinibPhysician's Choice

    Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

    FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementCholangiocarcinoma