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Clinical Trial Summary

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This is a multicenter, open, single-arm design clinical trial coducted in HSV-seropositive subjects with advanced pancreatic cancer to determine the safety, tolerability and preliminary efficacy of VG161 combined with PD-1 inhibitor (Nivolumab Injection).


Clinical Trial Description

A multicenter, open, single-arm design of clinical trial of VG161 in combined with PD-1 inhibitor (Nivolumab) in the treatment of patients with advanced pancreatic cancer with metastasis. The standard 3 + 3 design was used in the dose-finding study to explore the safety of the combination treatment, determine the recommended safe dose (RP2D) of the combination treatment in the second phase of efficacy study. The first cycle was observed until Day 28, i.e., DLT observation period. In the efficacy investigation trial, Simon two-segment design was used to continue to investigate the preliminary efficacy of the combination at a safe dose. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05162118
Study type Interventional
Source Zhejiang University
Contact Tingbo Liang, Doctor
Phone 13967159109
Email liangtingbo@zju.edu.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date March 8, 2022
Completion date December 22, 2025

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