Study of Futibatinib for Advanced Cholangiocarcinoma

This study is testing futibatinib (TAS-120), an oral targeted therapy, in people with advanced cholangiocarcinoma (bile duct cancer) that has specific genetic changes called FGFR2 fusions or rearrangements. You may be eligible if you have already received at least one gemcitabine and platinum-based chemotherapy. The study aims to confirm the benefits and evaluate the safety and effectiveness of two different doses of futibatinib (16 mg and 20 mg). Success will be measured by how many participants respond to the treatment, assessed 12 months after the study ends. This study is currently recruiting 120 participants.

Study design
This is an open-label, multinational, randomized Phase 2 study. Participants will be assigned by chance to receive either 16 mg or 20 mg of futibatinib daily.
What's involved
You will take futibatinib daily in 21-day cycles. Treatment continues until your disease progresses or other withdrawal criteria are met.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be assessed 12 months after the study completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05727176

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Taiho Oncology, Inc.
~120 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:TAS-120

At a glance

Recruiting sites
9 of 65 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ORR by independent central review
Measured over 12 months after the study completion
Advanced Cholangiocarcinoma
FGFR2 Fusions
Gene Rearrangement
65 sites across 29 states
South Korea7
Spain7
Texas6
Brazil5
Japan4
Poland4
Argentina3
Italy3

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  • ORR by independent central review12 months after the study completion

    defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on ICR