A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma

Key Inclusion Criteria: * Confirmed diagnosis of HCC by histological examination or by non-invasive criteria according to European Association for the Study of the Liver (EASL) or American Association for the Study of Liver Disease (AASLD) guidelines (Part 1, 2 and 3). * For Part 1 and 2, the patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib. * For Part 3, the patient has not received prior treatment with a TKI. * Child-Pugh class A with no clinically apparent ascites * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * For Part 1, willing to provide archived tumor tissue (if available) and willing to undergo pre- and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator) * For Part 2 and 3, all patients must have an FGF19 IHC result available. Only FGF19 IHC+ HCC patients will be eligible for Part 3. Key Exclusion Criteria: * Central nervous system metastases * Platelet count \<75,000/mL * Absolute neutrophil count \<1000/mL * Hemoglobin \<8 g/dL * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5x the upper limit of normal (ULN) * Total bilirubin \>2.5 mg/dL * International normalized ratio (INR) \>2.3 or prothrombin time (PT) \>6 seconds above control * Estimated (Cockroft-Gault formula) or measured creatinine clearance \<40 mL/min