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.
This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. The trial will be conducted in multiple dosing cohorts, and evaluated for safety to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). Dose limiting toxicity (DLT) evaluation period is for 4 weeks from the start of treatment Day 1 through Day 28.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
1. Dose level 1 2. Dose level 2 3. Dose level 3 4. Dose level 4 5. Dose level 5
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGMTD/RP2D
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
Time frame: During the 28 day DLT observation period
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
Time frame: 12 months
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: Multiple time points before and after administration
DCR
Disease control rate (DCR)
Time frame: 12 months
PFS
Progression-free survival (PFS)
Time frame: 12 months
OS
Overall Survival (OS)
Time frame: 12 months
Antibodies
VG2025 anti-drug antibodies (ADA) and neutralizing antibody (Nab)
Time frame: 12 months
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