TT-00420 (tinengotinib)

DRUG3 trials

Sponsors

TransThera Sciences (Nanjing), Inc., Akeso

Conditions

Advanced CholangiocarcinomaCholangiocarcinoma MetastaticHepatocellular Carcinoma (HCC)Intrahepatic Cholangiocarcinoma (Icc)

Phase 2

Study of TT-00420 (Tinengotinib) in Subjects With Cholangiocarcinoma Who Failed or Relapsed to Chemotherapy and FGFR Inhibitor

Active, not recruitingNCT06057571

TransThera Sciences (Nanjing), Inc.Cholangiocarcinoma Metastatic

Start: 2023-11-17End: 2025-12-31Target: 50Updated: 2025-08-21

A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.

RecruitingNCT07052253

AkesoHepatocellular Carcinoma (HCC)

Start: 2025-07-18End: 2027-12-31Target: 100Updated: 2026-03-16

Phase 3

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

Not yet recruitingNCT07328919

TransThera Sciences (Nanjing), Inc.Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma (Icc)

Start: 2026-01-31End: 2030-12-31Target: 138Updated: 2026-01-09

Related Papers

Tinengotinib (TT-00420) in advanced/metastatic FGFR2-altered cholangiocarcinoma following prior chemotherapy and FGFR inhibitor treatment: Results from a phase II study (FIRST-08).

Journal of Clinical Oncology2026-05-27