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

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

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

Study Overview

• Status: Recruiting
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Drug: Futibatinib; Drug: Zimberelimab; Drug: Gemcitabine; Drug: Cisplatin; Drug: Durvalumab; Drug: Pembrolizumab

• Study Type: Interventional
• Enrollment (Estimated): 784
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kotaro Suto; Phone Number: +81-3-3294-4527; Email: th-FOENIX-BTC-Clin.Dev@taiho.co.jp

Study Locations

• Australia
  • Brisbane, Australia
    • Not yet recruiting
    • Research Site
  • Melbourne, Australia
    • Not yet recruiting
    • Research Site
  • Perth, Australia
    • Not yet recruiting
    • Research Site
  • Sydney, Australia
    • Not yet recruiting
    • Research Site
• Japan
  • Aichi, Japan
    • Not yet recruiting
    • Research Site
  • Fukuoka, Japan
    • Recruiting
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka, Japan
    • Not yet recruiting
    • Research Site
  • Hokkaido, Japan
    • Not yet recruiting
    • Research Site
  • Kanagawa, Japan
    • Not yet recruiting
    • Kanagawa Cancer Center
  • Miyagi, Japan
    • Not yet recruiting
    • Research Site
  • Osaka, Japan
    • Not yet recruiting
    • Research Site
  • Tokyo, Japan
    • Not yet recruiting
    • Research Site
  • Tokyo, Japan
    • Recruiting
    • The Cancer Institute Hospital
  • Toyama, Japan
    • Recruiting
    • Toyama University Hopspital
  • Wakayama, Japan
    • Recruiting
    • Wakayama Medical University Hospital
• South Korea
  • Busan, South Korea
    • Not yet recruiting
    • Research Site
  • Hwasun, South Korea
    • Not yet recruiting
    • Research Site
  • Seongnam, South Korea
    • Not yet recruiting
    • Research Site
  • Seoul, South Korea
    • Not yet recruiting
    • Research Site
• Thailand
  • Bangkok, Thailand
    • Not yet recruiting
    • Research Site
  • Chiang Mai, Thailand
    • Not yet recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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;

2. 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.
3. Has radiographically measurable disease per RECIST v1.1.
4. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.
5. 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:

1. History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;
2. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;
3. Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Futibatinib + Zimberelimab + Gemcitabine + Cisplatin	Drug: Futibatinib; Futibatinib 20 mg will be administered orally once daily.; Other Names: TAS-120; Drug: Zimberelimab; Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.; Other Names: AB122; 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.
Active Comparator: Control Arm; Investigator's choice; Durvalumab or Pembrolizumab + Gemcitabine + Cisplatin	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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	Up to approximately 45 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Up to approximately 45 months
6-months PFS rate according to RECIST v1.1 using BICR and Investigator assessments	Up to approximately 45 months
Objective response rate (ORR) according to RECIST v1.1 using BICR and Investigator assessments	Up to approximately 45 months
Duration of response (DoR) according to RECIST v1.1 using BICR and Investigator assessments	Up to approximately 45 months
Adverse events (AEs)	Up to approximately 45 months

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Collaborators: Taiho Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Gemcitabine; Cisplatin; Pembrolizumab; Phase 3; Durvalumab; Fibroblast Growth Factor Receptor (FGFR); Zimberelimab; Futibatinib; TAS-120; AB122; Biliary Tract Cancer (BTC); Programmed Cell Death Protein 1 (PD-1)
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Limb Deformities, Congenital; Synostosis; Dysostoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Craniosynostoses; Syndactyly; Biliary Tract Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body; Acrocephalosyndactylia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Gemcitabine; Cisplatin; pembrolizumab; durvalumab; zimberelimab; futibatinib
• Other Study ID Numbers: 10059040; jRCT2071260018 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Taiho Group (Taiho) provides a platform for accepting researchers requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018.

Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher.

See: https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No