A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Open-label, uncontrolled, phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma
• Men or women, Age ≥18 years
• Patients with ECOG performance status 0 or 1
• Patients with histologically confirmed diagnosis of HCC not amenable to curative surgery or local therapy
• Patients with documented objective radiographic progression during or after local therapy or after treatment with sorafenib or lenvatinib or intolerance to or refusal to receive either agent
• Patients with at least one prior systemic therapy for HCC
• Patients eligible to be treated with nivolumab
• Patients with measurable disease based on RECIST v1.1
• Patients with Child-Pugh class A liver score within 7 days of first study dose
• Patients with no history of hepatic encephalopathy
• Patients with no prior or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control (patients with ascites only on radiographic imaging are eligible)
• Patients with HBV infection must have received antiviral therapy for at least 12 weeks and HBV viral load must be documented to be \<100 IU/mL within 7 days of first study dose
• Patients with no active co-infection with HBV and HCV or HBV and HDV
• Patients with no active drug or alcohol abuse