RecruitingPhase 3NCT07710885

Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer

A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Sponsor

Taiho Pharmaceutical Co., Ltd.

Enrollment

784 participants

Start Date

Jun 24, 2026

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer

Summary

To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cisplatin, a drug called Durvalumab, and others for people with biliary tract cancer. The study is currently recruiting participants at 21 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFutibatinib

Futibatinib 20 mg will be administered orally once daily.

DRUGZimberelimab

Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.

DRUGDurvalumab

Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion.

DRUGPembrolizumab

Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion.

DRUGGemcitabine

Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.

DRUGCisplatin

Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.

Locations(21)

Research Site

Brisbane, Australia

Research Site

Melbourne, Australia

Research Site

Perth, Australia

Research Site

Sydney, Australia

Research Site

Aichi, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Research Site

Fukuoka, Japan

Research Site

Hokkaido, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Research Site

Miyagi, Japan

Research Site

Osaka, Japan

Research Site

Tokyo, Japan

The Cancer Institute Hospital

Tokyo, Japan

Toyama University Hopspital

Toyama, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Research Site

Busan, South Korea

Research Site

Hwasun, South Korea

Research Site

Seongnam, South Korea

Research Site

Seoul, South Korea

Research Site

Bangkok, Thailand

Research Site

Chiang Mai, Thailand

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NCT07710885

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