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NCT Number: NCT07710885

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

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

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Key information

Conditions

Biliary Tract Cancer Acrocephalosyndactylia Biliary Tract Diseases Biliary Tract Neoplasms Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Digestive System Diseases Digestive System Neoplasms Dysostoses Limb Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Site Parkinson Disease 4, Autosomal Dominant Lewy Body Syndactyly Synostosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Brisbane, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma;
  • Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);
  • Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion.
  • Has radiographically measurable disease per RECIST v1.1.
  • Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.
  • Has an ECOG PS of 0 or 1 before administration of study treatment; Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.

Exclusion criteria

  • History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;
  • History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;
  • Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib
  • Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination.

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Treatment and study plan

Futibatinib

Drug

Futibatinib 20 mg will be administered orally once daily.

Other names: TAS-120

Zimberelimab

Drug

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

Other names: AB122

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.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 45 months

    • To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC whose primary tumor site is intrahepatic or extrahepatic cholangiocarcinoma
    • To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC

Secondary outcomes

  1. Progression-Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 using Blinded Independent Central Review (BICR) and Investigator assessment

    Time frame: Up to approximately 45 months

  2. 6-months PFS rate according to RECIST v1.1 using BICR and Investigator assessments

    Time frame: Up to approximately 45 months

  3. Objective response rate (ORR) according to RECIST v1.1 using BICR and Investigator assessments

    Time frame: Up to approximately 45 months

  4. Duration of response (DoR) according to RECIST v1.1 using BICR and Investigator assessments

    Time frame: Up to approximately 45 months

  5. Adverse events (AEs)

    Time frame: Up to approximately 45 months

Study contacts

Contact information is provided by the study sponsor or research team.

Kotaro Suto

CONTACT

[email protected]

+81-3-3294-4527

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Taiho Oncology, Inc.

Registry information

Official study title

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

Acronym: FOENIX-BTC

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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