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Clinical Study of VG161 Combined With Camrelizumab in Patients With Advanced Primary Hepatocellular Carcinoma

NCT06124001 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-11-15

No results posted yet for this study

Summary

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection.This study will be conducted in combination with camrelizumab in patients with advanced advanced primary hepatocellular carcinoma who have received at least one first-line treatment regimen. This is an open-label study divided into two parts.

Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.

Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.

Conditions

  • Primary Hepatocellular Carcinoma

Interventions

DRUG

Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))

Intratumoral injection only. Dosing days may be Days 1-2 or Days 1-3.

DRUG

camrelizumab for Injection

Administered once at 3 mg/kg intravenously on Days 8 of each cycle.

Sponsors & Collaborators

  • CNBG-Virogin Biotech (Shanghai) Ltd.

    lead INDUSTRY

Principal Investigators

  • Tingbo Tingbo, MD. PhD. · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-12-30
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06124001 on ClinicalTrials.gov