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

Recruiting now · Phase 3

Conditions studied: Biliary Tract Cancer

In brief

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 facts

Study ID: NCT07710885
Run by: Taiho Pharmaceutical Co., Ltd.
People needed: 784
Starts: 2026-06-24
Expected to finish: 2031-12-31
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Toyama University Hopspital — Toyama, Japan (enrolling)
Wakayama Medical University Hospital — Wakayama, Japan (enrolling)
National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan (enrolling)
The Cancer Institute Hospital — Tokyo, Japan (enrolling)
Research Site — Aichi, Japan
Research Site — Fukuoka, Japan
Research Site — Hokkaido, Japan
Kanagawa Cancer Center — Kanagawa, Japan
Research Site — Miyagi, Japan
Research Site — Osaka, Japan
Research Site — Tokyo, Japan
Research Site — Busan, South Korea
Research Site — Hwasun, South Korea
Research Site — Seongnam, South Korea
Research Site — Seoul, South Korea
Research Site — Bangkok, Thailand
Research Site — Brisbane, Australia
Research Site — Chiang Mai, Thailand
Research Site — Melbourne, Australia
Research Site — Perth, Australia
Research Site — Sydney, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.