NCT05727176

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.

Detailed description

This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements. Eligible patients will be randomized on a 1:1 basis to the following study arms: * Patients will receive futibatinib at an oral dose of 16 mg, administered daily (QD) on every day of a 21-day cycle. * Patients will receive futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle. Patients may continue to receive continuous futibatinib until documentation of progressive disease (PD) per RECIST 1.1, or until other withdrawal criteria are met, whichever comes first.

Conditions

• Advanced Cholangiocarcinoma
• FGFR2 Fusions
• Gene Rearrangement

Interventions

Type	Name	Description
DRUG	TAS-120	TAS-120 is an oral FGFR inhibitor

Timeline

• Start date: 2023-07-05
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-02-14
• Last updated: 2025-12-29

Locations

65 sites across 13 countries: United States, Argentina, Australia, Brazil, Canada, China, Hong Kong, Italy, Japan, Poland, Portugal, South Korea, Spain

Regulatory

• FDA-regulated drug study