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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
1. 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
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGSafety: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.
Time frame: 12 months
MTD/RP2D
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
Time frame: During the 28 day DLT observation period
Level of deoxyribonucleic acid (DNA)
Shedding profile of detectable VG2025 deoxyribonucleic acid (DNA)
Time frame: 12 months
Interleukin level
Evaluate the interleukin-12 (IL-12) and interleukin-12 (IL-15) levels
Time frame: 12 months
ORR
Objective response rate (ORR)
Time frame: 12 months
Duration of relief(DOR)
Duration of relief(DOR)
Time frame: 12 months
DCR
Disease control rate (DCR)
Time frame: 12 months
PFS
Progression-free survival (PFS)
Time frame: 12 months
Immunogenicity Parameters
Incidence of antibodies against VG2025, anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Time frame: 12 months
Efficacy and Safety of VG2025 and Its Correlation with CEA Levels
A preliminary analysis of the correlation between the efficacy and safety of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels.
Time frame: 12 months
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