Actively Recruiting
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid Tumors
Led by Shanghai Virogin Biotech Co., Ltd. · Updated on 2025-04-01
30
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent form.
- Age 18 to 75 years (inclusive), male or female.
- Advanced malignant solid tumors that have failed standard treatment and have no effective treatment options.
- Agree to use reliable contraception if of childbearing potential; females must have a negative blood pregnancy test within 7 days before enrollment.
You will not qualify if you...
- Received other investigational drug treatments within 4 weeks before the first study dose.
- Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before first study dose.
- Currently experiencing herpes simplex virus recurrence or infection with clinical symptoms such as oral herpes, herpetic keratitis, herpetic dermatitis, or genital herpes.
- Other active uncontrolled infections.
- Known alcohol or drug dependence.
- Mental disorders or poor compliance.
- Pregnant or breastfeeding women.
- Considered unsuitable for the study by the investigator due to serious systemic diseases or other reasons.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
Y
Yinan Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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