A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype)

- Prior treatment with at least 1 systemic agent, with documented progressive disease
after systemic agent(s), or documented adverse event(s) associated with prior
systemic agent(s) that resulted in discontinuance of that (those) agent(s)

- Not a candidate for curative treatments (e.g. resection, transplantation)

- Child-Pugh A (score of 5-6)

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate hematologic, hepatic and renal function

- Ability to provide, for central review, a tumor tissue sample to determine the level
of GPC-3 expression by IHC

- Measurable disease by RECIST criteria

Exclusion Criteria:

- Child Pugh B or C

- Known hepatocellular carcinoma with fibro-lamellar histology

- Known brain or leptomeningeal metastases

- Active infectious diseases requiring treatment except for hepatitis B and C

- History of organ allograft including liver transplant

- Anticipated or ongoing administration of anticancer therapies other than those
administered in this study

- Anticancer treatment within 2 weeks prior to entering the study

- Patients who have not fully recovered from toxicities associated with previous HCC
loco-regional or systemic therapies

- Patients receiving interferon therapy

- Pregnant or lactating women

- Known HIV positivity or AIDS-related illness

- History of significant hypersensitivity to similar agents (monoclonal antibody,
protein-included drugs, Chinese hamster ovary products)