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A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of VG2025 Intravenous Injection in Subjects With Advanced Solid Tumors
Sponsor: Virogin Biotech Ltd.
Summary
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.
Official title: An Open-label, Multicenter Phase I/IIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of VG2025 Intravenous Treatment in Subjects With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2026-09-04
Completion Date
2029-09-03
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection
1. Dose level 1 2. Dose level 2 3. Dose level 3 4. Dose level 4 5. Dose level 5 6. Dose level 6 7. Dose level 7
Locations (1)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China