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VG161 in Advanced Intrahepatic Cholangiocarcinoma
NCT06746480Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2022
- Primary completion
- Sep 2025
- Countries
- 1
- Sponsor
- Virogin Biotech
- Modality
- Gene Editing, Prophylactic Vaccines, Gene Silencing
- Drugs
- VG161
- Conditions
- intrahepatic cholangiocarcinoma (ICC)
01
Overview
Phase 2, open-label, single-arm trial of VG161 in intrahepatic cholangiocarcinoma (ICC), sponsored by Virogin Biotech. Primary endpoint: Objective Response Rate at 27 months. Started Mar 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Single Arm
Single-arm receiving VG161 intratumoral injections.
03
Who it enrols
Patients with advanced intrahepatic cholangiocarcinoma who failed at least one systemic first-line therapy, have measurable disease > 1.5 cm, and are HSV-1 antibody positive.
04
Endpoints
Primary
Objective Response Rate
Secondary
Progression-Free Survival
Overall Survival Rate
Overall Survival
Duration of Response
Peripheral Blood Lymphocyte Subsets
Cytokine Levels
T-cell Related Parameters
Safety Indicators
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