VG2062 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 VG2062, and recommended dose of VG2062 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
No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province
Hebei, China
RECRUITINGAdverse 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 VG2062 deoxyribonucleic acid (DNA)
Time frame: 12 months
ORR
Objective response rate (ORR)
Time frame: 12 months
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
OS
Overall Survival (OS)
Time frame: 12 months
Antibodies
VG2062 anti-drug antibodies (ADA) and neutralizing antibody (Nab)
Time frame: 12 months
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