NCT06057571

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

A Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Oral TT-00420 (Tinengotinib) Tablets in Subjects With Cholangiocarcinoma Who Failed or Relapsed to Prior Treatment of Chemotherapy and FGFR Inhibitor

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II, open-label, multicenter study to evaluate the efficacy and safety of oral TT-00420 (Tinengotinib) tablets in subjects with cholangiocarcinoma who failed or relapsed to prior treatment of chemotherapy and FGFR Inhibitor.

Detailed description

Approximately 50 subjects will be enrolled. Eligible subjects will receive tinengotinib 10 mg QD orally as the initial dose level in 21-day cycles until confirmed disease progression, intolerable toxicity, death, or withdrawal of consent.

Conditions

• Cholangiocarcinoma Metastatic

Interventions

Type	Name	Description
DRUG	TT-00420 (tinengotinib)	TT-00420 (tinengotinib) tablet will be administered orally once daily per protocol defined schedule.

Timeline

• Start date: 2023-11-17
• Primary completion: 2025-07-27
• Completion: 2025-12-31
• First posted: 2023-09-28
• Last updated: 2025-08-21

Locations

29 sites across 1 country: China