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.
Age 18 to 75 years (inclusive); Open to all genders.
Phase I: Participants with advanced solid tumors who have failed standard therapy (due to intolerance or disease progression following treatment) as confirmed by histopathology and/or cytology, or for whom no standard therapy is currently approved.
Participants must test positive for Herpes Simplex Virus Type 1 (HSV-1) antibodies (HSV-1 IgG or HSV-1 IgM).
Within 7 days prior to the first administration of the study drug, female participants of childbearing potential must confirm a negative serum pregnancy test. Participants of childbearing potential and their partners must agree to use effective contraception during the study drug administration period and for 90 days after the last dose.
Participants experiencing an active herpes simplex virus (HSV) recurrence with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, or genital herpes; or those requiring anti-HSV treatment.
Participants who have received anticancer therapy or radiation therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to enrollment.
Underwent major surgery (excluding needle biopsy or intravenous catheterization) or interventional/ablation therapy within 4 weeks prior to the first dose.
Individuals with addiction to alcohol, drugs, or other substances; participants who have been abstinent for more than 2 years are eligible for en.
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 6. Dose level 6 7. Dose level 7
Safety：Adverse Events (AEs) and Serious Adverse Events (SAEs)
The assessment is conducted by monitoring the severity of AEs and SAEs during the study, including performing protocol-specified vital signs checks, physical examinations, 12-lead ECGs, laboratory tests, DLTs, and so on.
MTD/RP2D
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
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)
Duration of relief（DOR）
Duration of relief（DOR）
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