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

Sponsor
Taiho Pharmaceutical Co., Ltd.
Study ID
NCT07710885
Phase
PHASE3
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Futibatinib — DRUG
    Futibatinib 20 mg will be administered orally once daily.
  • Zimberelimab — DRUG
    Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.
  • Durvalumab — DRUG
    Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion.
  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion.
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
  • Cisplatin — DRUG
    Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.

Study Details

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

Key Dates

First listed
Jul 17, 2026
Start date
Jun 24, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
784 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Futibatinib + Zimberelimab + Gemcitabine + Cisplatin
  • Active Comparator: Control Arm
    Investigator's choice; Durvalumab or Pembrolizumab + Gemcitabine + Cisplatin

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 45 months ]

Central Contacts

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