Phase I Study to Evaluate Safety and Effectiveness of VG161 Injection in Adults with Advanced Primary Liver Cancer

What this Trial Is About

Researchers are evaluating VG161, a recombinant human IL1215PDL1B oncolytic HSV-1 injectable drug, in adults with advanced primary liver cancer who have not responded to standard treatments. This open-label Phase 1 study aims to assess the safety, tolerability, and preliminary effectiveness of VG161 in subjects who are HSV-seropositive. The study is divided into two parts an initial dose-escalation phase followed by an extended dose evaluation phase. In Part 1, participants receive VG161 in ascending doses through intratumoral injections administered on Day 1 or over multiple days up to Day 3, with doses ranging from 1.0108 to 1.7108 PFU. This part includes accelerated titration and dose escalation cohorts to determine the maximum tolerated dose and recommended dose. Part 2 involves treatment at the recommended dose identified in Part 1 to further evaluate effectiveness and safety. Participants will be monitored for adverse events, dose-limiting toxicities, and immune response markers over periods up to 7 months, with survival rates assessed up to 17 months. Evaluations include clinical exams, laboratory tests, and imaging to assess tumor response and immune parameters. Ongoing safety and pharmacokinetics assessments are conducted throughout the study duration, providing comprehensive data on VG161s impact in this patient population.

Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer