drugset / Trial / NCT07328919
Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.
Timeline
- Start
- 2026-01
- Primary completion
- 2029-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Irinotecan | Small molecule | — | — |
| Comparator | Leucovorin | Small molecule | — | — |
| Comparator | Oxaliplatin | Small molecule | — | — |
| Subject | Tinengotinib | Small molecule | 10 mg | Oral |
| Comparator | fluorouracil | Small molecule | — | — |