ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abivax S.A.
• Collaborator: C3 Research Associates
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with tyrosine kinase inhibitor treatment within 2 weeks of first study dose

• Patients with esophageal or gastric variceal bleeding within the past 6 months

• Patients with portal vein invasion at the main portal (Vp4) or the inferior vena cava or cardiac involvement of HCC based on imaging

• Patients with previous solid organ or hematologic transplantation

• Patients with active autoimmune disease requiring systemic treatment in the past 2 years

• Patients with diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days before first study dose

• Patients with previous locoregional therapy or major surgery to the liver within 6 weeks before first study dose

• Patients with minor surgery to liver or another site within 1 week before first study dose