臨床研究等提出・公開システム

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 (FOENIX-BTC)

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

Nasermoaddeli Ali

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

th-FOENIX-BTC-Clin.Dev@taiho.co.jp

Suto Kotaro

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3294-4527

th-FOENIX-BTC-Clin.Dev@taiho.co.jp

Recruiting

June. 01, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(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.

(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

Both

Biliary Tract Cancer

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.

OS

- 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

+81-92-642-5858

Yes

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

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