NCT04806464

Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer

A Dose Ascending, Open Phase I Clinical Study to Evaluate the Safety, Tolerability , Pharmacokinetics Characteristics and Preliminary Effectiveness of VG161 in Subjects with Advanced Primary Liver Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: CNBG-Virogin Biotech (Shanghai) Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This phase I study will be conducted in HSV-seropositive subjects with advanced primary liver cancer that are refractory to conventional therapies. This is an open label study and it's divided into two parts. Part 1: This part is ascending dose design to determine the safety and tolerability of VG161 and find recommended dose of VG161. Part 2: This part is extended dose design to determine the effectiveness of VG161.

Detailed description

Part 1: This part will be conducted in 5 dose ascending cohorts, including 2 accelerated titration design dose group and 3 dose escalation groups. Descriptive statistics will be used to summarize data. Part 2: This part will only include the part 1 recommended dose. Hypothesis test and descriptive statistics will be used to summarize data.

Conditions

• Primary Liver Cancer

Interventions

Type	Name	Description
DRUG	Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))	Intratumoral injection only. The dosing date can be the Day 1 only or Days 1 through 5.

Timeline

• Start date: 2021-03-16
• Primary completion: 2022-03-21
• Completion: 2024-12-31
• First posted: 2021-03-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China