NCT04919642

Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma

A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) Tablet in Adult Patients With Advanced Cholangiocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma.

Detailed description

This is a Phase II, open-label study to evaluate the efficacy and safety of TT00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.

Conditions

• Cholangiocarcinoma
• FGFR2 Fusion
• FGFR2 Gene Mutation
• FGFR1 Alteration
• FGFR3 Alteration

Interventions

Type	Name	Description
DRUG	TT-00420	TT-00420 tablet, administered orally once daily

Timeline

• Start date: 2021-12-07
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2021-06-09
• Last updated: 2024-06-25

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study