Actively Recruiting
An Open-label, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Biological Effects of VG2062 in Patients With Advanced Solid Tumors
Led by Shanghai Virogin Biotech Co., Ltd. ยท Updated on 2026-03-25
30
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VG2062, a recombinant human IL12/15 dual-regulated oncolytic HSV-1 injection, in people with advanced malignant solid tumors that have not responded to standard treatments. This Phase I, open-label study focuses on participants who have been previously exposed to herpes simplex virus (HSV). The trial aims to determine the safety, tolerability, and recommended dose of VG2062 for future Phase II studies. The study uses a standard 3+3 dose-escalation design with multiple dosing groups, where small cohorts of participants receive increasing doses of VG2062 to monitor safety and identify the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). The dose limiting toxicity (DLT) period lasts 28 days from the first treatment. Up to 30 HSV-seropositive participants will be enrolled in this single-arm trial. Participants will be closely monitored for adverse events and serious adverse events over 12 months, with key safety evaluations during the first 28 days. Researchers will also assess pharmacokinetics, biological effects, tumor response rates, duration of response, disease control, progression-free survival, overall survival, and antibody levels. The total participation includes treatment, follow-up, and safety assessments lasting up to one year.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2062 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 with failed standard treatment and no effective treatment currently
- Patients of childbearing potential must agree to use reliable contraception during the trial and for 90 days after dosing
- Females of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment
You will not qualify if you...
- Received other unlisted clinical trial drugs within 4 weeks before first study drug dose
- Major organ surgery or significant trauma within 4 weeks before first study drug dose (excluding needle biopsy)
- Active herpes simplex virus recurrence or infection with symptoms such as oral 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 due to other serious systemic diseases or other reasons 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.
1 visit (in-person)
Duration - 28 days per dose escalation cohort
Participants receive escalating doses of the investigational drug VG2062 to evaluate safety and determine the maximum tolerated dose.
Multiple visits over 28 days during each dosing cohort
Duration - Up to 12 months
Participants are monitored for safety, pharmacokinetics, and biologic effects for up to 12 months after treatment.
Regular visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province
Hebei, China
Actively Recruiting
Research Team
S
Shu hang Wang
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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