Biliary Tract Cancer
Conditions
Interventions
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
Sponsors
Nasermoaddeli Ali
Eligibility
Sex/Gender
All
Inclusion criteria
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 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.
Exclusion 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
Australia, Japan, South Korea, Thailand
Contacts
Public ContactYuko Ishibashi
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed