NCT06124001

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

An Open-label Phase Ib/IIa Clinical Trial of VG161 Combined With Camrelizumab in the Treatment of Advanced Primary Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (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 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.

Detailed description

Part1(Phase Ib primary objective): To evaluate the safety and tolerability of VG161 administered by intratumoral injection combined with camrelizumab in the treatment of patients with advanced advanced primary hepatocellular carcinoma who have received at least one first-line treatment regimen. explore the most suitable recommended Phase II dose (RP2D) for combination therapy, and determine the recommended regimen for combination therapy in Phase IIa clinical trials. Secondary objectives:1) Preliminary evaluation of the anti-tumor activity of VG161 combined with camrelizumab in the treatment of patients with advanced primary hepatocellular carcinoma;2) Monitor changes in immunological indicators related to pharmacodynamics;3) Evaluate the impact of herpes simplex virus type I antibody titer levels on the safety and effectiveness of VG161. Part2(Phase IIa Primary Objective): To evaluate the efficacy of VG161 in combination with carrelizumab in the treatment of patients with advanced primary hepatocellular carcinoma, the main observation index was objective response rate (ORR). Secondary objectives: 1) secondary observations to evaluate the efficacy of combination therapy, including disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and duration of remission (DOR);2) monitoring changes in pharmacodynamic-related immunological indicators;3) To further evaluate the safety of VG161 in combination with carrelizumab.4) To evaluate the effect of herpes simplex virus type I antibody titer level on the safety and efficacy of VG161

Conditions

• Primary Hepatocellular Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-30
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2023-11-09
• Last updated: 2023-11-15