Actively Recruiting
A Dose Escalation, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in the Treatment of Patients with Advanced Malignant Solid Tumors
Led by Shanghai Virogin Biotech Co., Ltd. ยท Updated on 2025-04-01
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VG2025, a recombinant human IL12/15 dual-regulated oncolytic HSV-1 injection, in adults with advanced malignant solid tumors that have not responded to standard treatments. This open-label Phase I trial aims to determine the safety, tolerability, and recommended dose of VG2025 for future studies. The trial is conducted in patients who are positive for herpes simplex virus (HSV) and refractory to conventional therapies. The study uses a standard 3+3 dose-escalation design with multiple dosing cohorts, treating up to 30 HSV-seropositive participants. Each cohort involves three patients receiving escalating doses of VG2025, with careful monitoring for dose-limiting toxicities during the first 28 days of treatment. This design helps establish the maximum tolerated dose and the recommended dose for Phase II trials. Participants will be closely monitored for safety and biological effects over 12 months, including adverse events, serious adverse events, DNA levels, interleukin levels, tumor response rates, disease control rates, progression-free survival, overall survival, and antibody responses. The trial includes frequent assessments during the dose-limiting toxicity period and long-term follow-up to evaluate both treatment impact and safety.
CONDITIONS
Brief 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 not responding to standard treatment.
- Agreement to use reliable contraception during the trial and for 90 days after dosing if of childbearing potential.
- Negative blood pregnancy test within 7 days before enrollment for females of childbearing potential.
You will not qualify if you...
- Participation in another unlisted drug clinical trial within 4 weeks before first dose.
- Major organ surgery or significant trauma within 4 weeks before first dose (excluding needle biopsy).
- Active herpes simplex virus recurrence or infection with clinical symptoms.
- Other active uncontrolled infections.
- Known alcohol or drug dependence.
- Mental disorders or poor compliance.
- Pregnant or breastfeeding women.
- Any other serious systemic diseases or reasons judged unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days for dose limiting toxicity evaluation period
Participants receive escalating doses of the investigational drug VG2025 to evaluate safety, tolerability, and biologic effects.
Duration - Up to 12 months
Participants are monitored for safety, adverse events, and biological markers for up to 12 months after treatment.
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital๏ผZhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
Y
Yinan Shen
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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