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

NCT07710885 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 10059040jRCT2071260018
• Study Type: interventional
• Target: 784
• Locations: 4 countries
• Sites: 21

Brief 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

Biliary Tract Cancer

Keywords

Futibatinib; Biliary Tract Cancer (BTC); TAS-120; Zimberelimab; AB122; Gemcitabine; Cisplatin; Durvalumab; Pembrolizumab; Phase 3; Fibroblast Growth Factor Receptor (FGFR); Programmed Cell Death Protein 1 (PD-1)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Futibatinib + Zimberelimab + Gemcitabine + Cisplatin

Drug: Futibatinib; Drug: Zimberelimab; Drug: Gemcitabine; Drug: Cisplatin

Control Arm

ACTIVE COMPARATOR

Investigator's choice; Durvalumab or Pembrolizumab + Gemcitabine + Cisplatin

Drug: Durvalumab; Drug: Pembrolizumab; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Gemcitabine DRUG

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

Control Arm; Treatment Arm

Cisplatin DRUG

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

Control Arm; Treatment Arm

Futibatinib DRUG

Futibatinib 20 mg will be administered orally once daily.

Also known as: TAS-120

Treatment Arm

Zimberelimab DRUG

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

Also known as: AB122

Treatment Arm

Durvalumab DRUG

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

Control Arm

Pembrolizumab DRUG

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead
• Taiho Oncology, Inc.: collaborator

Study Sites (21)

Research Site

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

Aichi, Japan

NOT YET RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

RECRUITING

Research Site

Fukuoka, Japan

NOT YET RECRUITING

Research Site

Hokkaido, Japan

NOT YET RECRUITING

Kanagawa Cancer Center

Kanagawa, Japan

NOT YET RECRUITING

Research Site

Miyagi, Japan

NOT YET RECRUITING

Research Site

Osaka, Japan

NOT YET RECRUITING

Research Site

Tokyo, Japan

NOT YET RECRUITING

The Cancer Institute Hospital

Tokyo, Japan

RECRUITING

Toyama University Hopspital

Toyama, Japan

RECRUITING

Wakayama Medical University Hospital

Wakayama, Japan

RECRUITING

Research Site

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

Bangkok, Thailand

NOT YET RECRUITING

Research Site

Chiang Mai, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms; Acrocephalosyndactylia; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

futibatinib; zimberelimab; durvalumab; pembrolizumab; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Craniosynostoses; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Syndactyly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Kotaro Suto

CONTACT

+81-3-3294-4527; th-FOENIX-BTC-Clin.Dev@taiho.co.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 17, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

KR (4); AU (4); JP (11); TH (2)