Clinical Study of VG161 in Subjects With Advanced Primary Liver Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Part 1: This part will be conducted in 5 dose ascending cohorts, including 1 single dose accelerated titration design pilots and 4 multiple 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04806464
Study type	Interventional
Source	CNBG-Virogin Biotech (Shanghai) Ltd.
Contact	Tingbo Liang, MD.PhD.
Phone	0571-87236666
Email	liangtingbo@zju.edu.cn
Status	Recruiting
Phase	Phase 1
Start date	March 16, 2021
Completion date	December 31, 2022

View Details

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