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VG2025 in Advanced Solid Tumors
NCT07682870Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2026
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- Virogin Biotech
- Drugs
- VG2025
- Conditions
- solid tumor
01
Overview
Phase 2, open-label, single-arm trial of VG2025 in solid tumor, sponsored by Virogin Biotech. Primary endpoints: Adverse Events and Serious Adverse Events at 12 months and Maximum Tolerated Dose and Recommended Phase 2 Dose at 28 days. Started Sep 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
3+3 design
Open label, single-arm trial using standard 3+3 design with cohorts of three patients receiving VG2025 across 7 dose levels.
03
Who it enrols
Adults aged 18-75 with advanced solid tumors who have failed standard therapy and are positive for HSV-1 antibodies. Excludes patients with active HSV recurrence, recent anticancer therapy within 4 weeks, or recent major surgery.
04
Endpoints
Primary
Adverse Events and Serious Adverse Events
Maximum Tolerated Dose and Recommended Phase 2 Dose
Secondary
Level of deoxyribonucleic acid
Interleukin level
Objective Response Rate
Duration of Response
Disease Control Rate
Progression-Free Survival
Immunogenicity Parameters
Efficacy and Safety of VG2025 and Its Correlation with CEA Levels
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