FOENIX-CCA4

Prior treatment

• Treatment with any of the following within the specified time frame prior to the first dose of futibatinib: a. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks b. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks c. Any noninvestigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib administration. Endocrine therapy is allowed for patients with breast or prostate cancer d. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives (whichever is shorter) e. Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter. g. Patients with prior FGFR-directed therapy
• Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.

Other illness

• Current evidence of clinically significant retinal disorder
• Known hypersensitivity or severe reaction to futibatinib or its excipients.

Lab values

• A patient must not meet any of the following exclusion criteria to be eligible for participation in this study: 1. History or current evidence of calcium and phosphate homeostasis disorder
• A serious illness or medical condition(s) including (but not limited to) the following: a. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month b. Known acute systemic infection c. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV within the previous 2 months; if >2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms d. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib e. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study

Other

• Pregnant or lactating female

• A patient must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
• Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
• Documentation of radiographic disease progression on the most recent prior therapy Measurable disease performance status 0 or 1 Adequate organ function
• Documentation of radiographic disease progression on the most recent prior therapy
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1