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

Sponsor
CNBG-Virogin Biotech (Shanghai) Ltd.
Study ID
NCT06124001
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Primary Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) — DRUG
    Intratumoral injection only. Dosing days may be Days 1-2 or Days 1-3.
  • camrelizumab for Injection — DRUG
    Administered once at 3 mg/kg intravenously on Days 8 of each cycle.

Study Details

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.

Key Dates

First listed
Nov 9, 2023
Start date
Nov 30, 2023
Status verified
Nov 2023
Primary completion
Dec 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Single Arm
    VG161: 1)1.0 × 10 \^ 8 PFU daily for 2 consecutive days on Days 1-2 of each cycle (D1-D2); 2)1.0 × 10 \^ 8PFU daily for 3 consecutive days on Days 1-3 of each cycle (D1-D3); camrelizumab: 3 mg/kg every 3 weeks (D8) Part2: Depends on the recommended dose in Part1

Primary Outcome Measure

Phase Ib:RP2D/MTD [ Time Frame: through Phase Ib study completion, an average of 8 months ]

Central Contacts