MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.

A Phase 1b/2, Open-label, Randomized Study of MEDI-573 in Combination With Sorafenib Verses Sorafenib Alone in Adult Subjects With Unresectable or Metastatic Hepatocellular Carcinoma

A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).

Inclusion Criteria:

• Age ≥ 18 years or minimum age of consent per local regulations at the time of screening
• Unresectable or metastatic hepatocellular carcinoma
• ECOG Performance Status ≤ 2
• Life expectancy of ≥ 3 months;

Exclusion Criteria:

• Child-Pugh Score for Cirrhosis Mortality > 7 points
• Prior or current system anti-cancer therapy for HCC, including cytotoxic, biologic, targeted or experimental therapy
• Prior local treatment for HCC less than 4 weeks prior to initiating study treatment
• Active second malignancy
• Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to initiating study treatment
• Thrombotic or embolic events within 6 months prior to initiating study treatment
• Ongoing pancreatitis
• Uncontrolled or refractory ascites
• Evidence of ongoing spinal cord compression, known carcinomatous meningitis, or known leptomeningeal carcinomatosis
• Hepatic encephalopathy > Grade 1
• Active brain metastases with exceptions
• Poorly controlled diabetes mellitus
• Active coronary artery disease
• Uncontrolled hypertension