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.
Signed written informed consent form.
Age 18 to 75 years (inclusive), male or female.
Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage.
Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.
Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.
Other active uncontrolled infection.
Single group
Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection
Drug1. Dose level 1 2. Dose level 2 3. Dose level 3 4. Dose level 4 5. Dose level 5
MTD/RP2D
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs)as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Level of deoxyribonucleic acid (DNA)
Shedding profile of detectable VG2025 deoxyribonucleic acid (DNA)
Interleukin level
Evaluate the interleukin-12 (IL-12) and interleukin-12 (IL-15) levels
ORR
Objective response rate (ORR)
DCR
Disease control rate (DCR)
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