Phase 1-2 Study of ABX196 Combined With Nivolumab to Treat Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacodynamic effects, and early effectiveness of ABX196 combined with nivolumab in adults with hepatocellular carcinoma, a type of liver cancer. This open-label, uncontrolled phase 1-2 study aims to explore these outcomes in patients whose cancer is not suitable for curative surgery or local therapy and who have received prior systemic treatment. The study includes two phases a Dose Escalation Phase and an Expansion Phase. Nivolumab is given as a 30-minute intravenous infusion on Days 1 and 15 of each 28-day cycle. ABX196 is administered as an intramuscular injection about 120 minutes after the nivolumab infusion on Day 1 of every other 28-day cycle, meaning every 8 weeks. Different doses of ABX196 0.1, 0.2, and 0.4 micrograms are tested during the study. Participants will be monitored through regular assessments including scans to measure tumor response, blood tests such as alpha fetoprotein levels every 2 weeks, and evaluations of liver function and overall health. The main outcome measured is the incidence of adverse events over about one year. Secondary outcomes include response rates, duration of response, progression-free survival, and biomarker levels, with some assessments continuing up to 24 months. Safety and tolerability will be closely observed throughout the study period.

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma