Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma

Key Inclusion Criteria:

* Child-Pugh class of A
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5.0 × ULN
* Total bilirubin ≤3.0 mg/dL
* Platelets ≥75,000 /mL
* International Normalized Ratio (INR) ≤1.7
* Subjects must meet the protocol-defined criteria for both hepatitis B virus (HBV) and hepatitis C virus (HCV) status

Key Exclusion Criteria:

* History of significant cardiovascular disease will be excluded
* History of liver transplant.
* Diagnosis of fibrolamellar HCC or tumors of mixed histology.
* Subjects known to be positive for Human immunodeficiency virus (HIV) infection.
* Known central nervous system (CNS) or brain metastases.
* Poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
* Symptomatic encephalopathy within 3 months prior to the first dose of TKM-080301 and/or requirement for medication for encephalopathy.
* Esophageal variceal bleeding within 2 weeks prior to the first dose of TKM-080301.
* Asthma or chronic obstructive pulmonary disease (COPD) requiring daily medication.
* Prior therapy with nitrosoureas or mitomycin within 6 weeks prior to the first dose of TKM-080301.
* Prior therapy with any biologic chemotherapeutic or investigational drug within 5 half-lives or 3 weeks, whichever is longer prior to the first dose of TKM 080301.