RecruitingPhase 1NCT04806464

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


Sponsor

CNBG-Virogin Biotech (Shanghai) Ltd.

Enrollment

44 participants

Start Date

Mar 16, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of treatment called VG161 — an engineered virus that can both attack cancer cells directly and stimulate the immune system — in people with advanced liver cancer that has stopped responding to standard therapies. **You may be eligible if...** - You have advanced liver cancer (hepatocellular carcinoma, bile duct cancer, or combined type) - Your cancer is no longer responding to, or you cannot tolerate, standard treatments - You are in acceptable general health - You have measurable tumors that can be evaluated during the study **You may NOT be eligible if...** - You have severe liver failure or other organ failure - You are pregnant or breastfeeding - You have certain immune system conditions or are on immune-suppressing medications - You have uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant 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.


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT04806464


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