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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 Biliary Tract Cancer (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 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.

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 Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib
4. 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.

• Brisbane, Australia
• Melbourne, Australia
• Perth, Australia
• Sydney, Australia
• Aichi, Japan
• Fukuoka, Japan
• Fukuoka, Japan
• Hokkaido, Japan
• Kanagawa, Japan
• Miyagi, Japan
• Osaka, Japan
• Tokyo, Japan
• Tokyo, Japan
• Toyama, Japan
• Wakayama, Japan
• Busan, South Korea
• Hwasun, South Korea
• Seongnam, South Korea
• Seoul, South Korea
• Bangkok, Thailand
• Chiang Mai, Thailand