Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma

This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.

Inclusion Criteria:

• Age ≥18 years
• Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
• Child-Pugh score A5 or A6.
• ECOG Performance Status of ≤2.

Exclusion Criteria:

• Known central nervous system or brain metastases.
• Prior anti-IGF-1R therapy.
• Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
• Concurrent anticancer therapy.
• History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
• Acute hepatitis
• Fibrolamellar HCC

Other protocol-defined inclusion/exclusion criteria may apply