An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B as First Line Monotherapy in Patients With Unresectable Hepatocellular Cancer.

Inclusion Criteria:

1. The patient must have histologically-confirmed, unresectable HCC

2. The patient has at least one unidimensionally-measurable target lesion (≥ 2 cm with
conventional techniques, or ≥ 1 cm by spiral CT or MRI), as defined by Response
Evaluation Criteria in Solid Tumors (RECIST).[61] Target lesion(s) must not lay
within a previously irradiated, ablated, or chemoembolized area. If a target lesion
does lie in such an area, there must be evidence of growth on successive imaging
studies, including tumor hypervascularity, in order for such a lesion to be
considered a target lesion

3. The patient has a Cancer of the Liver Italian Programme (CLIP) score of 0-3 (see
Section 3.2.1)

4. The patient has a Child-Pugh Classification score of A or B (liver dysfunction, see
Section 3.2.1)

5. The patient has provided signed informed consent

Exclusion Criteria:

1. The patient has received prior systemic chemotherapy, biologic or anti-angiogenic
therapy, or investigational systemic therapy for HCC

2. The patient has had bleeding from esophageal or gastric varices during the 3 months
prior to study participation. Note: If the patient has any history of known
esophageal varices, or evidence of esophageal varices on CT/MRI, the patient must
undergo endoscopic evaluation prior to study entry (minimally invasive capsule
esophageal endoscopy is an acceptable initial modality). The patient with
endoscopically detected esophageal varices is eligible provided he/she meets all
other entry criteria. The patient with any history or current evidence of esophageal
varices must receive oral beta-blocker therapy throughout participation while on
study, he/she may receive optimal endoscopic therapy as determined by the consulting
gastroenterologist or hepatologist, and must undergo regular endoscopic follow-up
throughout participation while on study

3. The patient has acute hepatitis

4. The patient has central nervous system (CNS) metastases or carcinomatous meningitis

5. The patient has poorly-controlled hypertension (ie, blood pressure in abnormal range
despite medical management)