NIPH Clinical Trials Search

A Phase 3 Trial of Futibatinib (TAS-120) in Patients with Advanced Biliary Tract Cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Biliary Tract Cancer
Date of first enrollment	01/06/2026
Target sample size	784
Countries of recruitment	South Korea,Japan,Thailand,Japan,Australia,Japan
Study type	Interventional
Intervention(s)	Arm A: Futibatinib and zimberelimab plus gemcitabine/cisplatin therapy Futibatinib 20 mg will be administered orally once daily. Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion over 30 minutes. Cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W via intravenous infusion. Arm B: Durvalumab plus gemcitabine/cisplatin therapy or Pembrolizumab plus gemcitabine/cisplatin therapy Durvalumab 1500 mg or Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion. Cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 will be administered Day 1 and 8 of Q3W via intravenous infusion.

Outcome(s)

Primary Outcome	OS
Secondary Outcome	- PFS, 6-months PFS rate, ORR, and DoR according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 using Blinded independent central review (BICR) and Investigator assessments - Adverse events (AEs), laboratory findings, World Health Organization (WHO) /Eastern Cooperative Oncology Group (ECOG) performance status (PS), and vital signs

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 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 WHO/ECOG PS of 0 or 1 before administration of study treatment; (6) Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.
Exclude 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 FGFR-directed therapy including futibatinib (4) Has prior treatment with an anti-PD-L1, anti-PD-1, anti-Cytotoxic T-lymphocyteassociated protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other ICI or agonist as monotherapy or in combination (5) Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis