Open-label Multicenter Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Hepatocellular Carcinoma

Inclusion Criteria: * Patients histologically or cytologically confirmed, unresectable, or metastatic HCC * Child-Pugh Category A or B (score 6-7); stable, well-compensated, mild cirrhosis with minimal or no ascites * Male or female patients 18 years of age or older * Patients must be willing and able to read, understand and sign a written informed consent form * Male, or female of childbearing potential, must agree to use double barrier contraception, oral contraceptives or other ways to avoid pregnancy during the study and for 90 days after the last day of treatment * Life expectancy of greater than 3 months * Plasma haptoglobin ≥ LLN (lower limit of normal) Exclusion Criteria: * Patients confirmed with hemolysis confirmed by serum lactate dehydrogenase, serum haptoglobin or indirect bilirubin levels * Patients who have received a blood transfusion within 4 weeks of enrolment * Patients with infiltrating diffuse hepatocellular carcinoma, Type 1 or 2 diabetes mellitus, Hepatitis B or Hepatitis C infection * Systemic chemotherapy-naive patients * Patients with significant cardiovascular impairment, including history of congestive heart failure, unstable angina, myocardial infarction, or serious cardiac arrhythmia within the last 6 months * Patient with a history of tumor rupture * Patients with serious non-healing wound , ulcer or bone fracture * Known positive human immunodeficiency virus (HIV) test