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

NCT07710885 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 784

Last updated 2026-07-17

No results posted yet for this study

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

Conditions

Interventions

DRUG

Futibatinib

Futibatinib 20 mg will be administered orally once daily.

DRUG

Zimberelimab

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

DRUG

Durvalumab

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

DRUG

Pembrolizumab

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

DRUG

Gemcitabine

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

DRUG

Cisplatin

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

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    collaborator INDUSTRY

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-24
Primary Completion
2030-04-30
Completion
2031-12-31
FDA Drug
Yes

Countries

  • Australia
  • Japan
  • South Korea
  • Thailand

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07710885 on ClinicalTrials.gov