Phase IIaIIb Study of VG161 Alone and With Nivolumab for Treating Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

What this Trial Is About

Researchers are evaluating VG161, an investigational drug, alone and in combination with Nivolumab for treating patients with hepatocellular carcinoma HCC or intrahepatic cholangiocarcinoma ICC. This phase IIaIIb clinical trial aims to assess the safety, tolerability, and effectiveness of VG161 in different patient cohorts, including a safety run-in cohort, monotherapy cohorts for HCC and ICC, and a combination therapy cohort with Nivolumab. The trial involves multiple centers and includes patients with advanced-stage liver cancers who have undergone prior treatments. Participants receive intratumoral injections of VG161 at a specified dose level for three days in the safety run-in cohort and monotherapy cohorts. In the combination cohort, patients receive VG161 injections plus intravenous Nivolumab on days 8 and 15 of each treatment cycle, with possible dose adjustments after the first cycle. The study includes separate periods for enrollment and evaluation within each cohort, with planned stopping rules based on responses and progression-free survival to determine continuation or expansion of the trial groups. Throughout the study, participants undergo regular assessments including safety monitoring, tumor response evaluations, and collection of blood samples to measure VG161 concentrations, immune markers, and viral shedding up to 12 months. Researchers will evaluate outcomes such as objective response rate, progression-free survival at three months, overall survival, duration of response, and immunogenicity. The total involvement may last up to a year, with close follow-up to assess treatment effects and patient safety.

An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma