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

Prior treatment

• Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib

Other illness

• History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;

Lab values

• History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;
• 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.

• 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.