VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This Phase I study will be conducted in 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 VG161, and recommended dose of VG161 for Phase II trials.
The trial will be conducted in 7 dose ascending cohorts, including 3 single dose accelerated titration design pilots and 4 multiple dose escalation groups. Descriptive statistics will be used to summarize all data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Intratumoral injection only. The dosing date can be the Day 1 only or Days 1 through 5.
ShangHai East hospital
Shanghai, Shanghai Municipality, China
RECRUITINGXin Hua Hospital Affiliated to ShangHai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGMTD/RP2D
MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)
Time frame: 1 month
Occurence of DLT
Occurence of DLT (Dose Limiting Toxicity)
Time frame: 1 month
Numbers of DLT
Numbers of DLT (Dose Limiting Toxicity)
Time frame: 1 month
Occurence of AE and SAE(NCI CTCAE 5.0)
Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Time frame: 7 months
Frequency of AE and SAE(NCI CTCAE 5.0)
Frequency of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Time frame: 7 months
Tmax(h)
Time to peak
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Cmax(copies/ugDNA)
Maximum concentration
Time frame: At the end of Cycle 1 (each cycle is 28 days)
ORR
Evaluate Objective Response Rate by RECIST 1.1.
Time frame: 7 months
DCR
Evaluate Disease Control Rate by RECIST 1.1.
Time frame: 7 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
mPFS
Evaluate medium Progression Free Survival by RECIST 1.1.
Time frame: 7 months
CD3+, CD4+, CD8+
Concentration of CD3+, CD4+, CD8+
Time frame: 7 months
IL15
Concentration of IL15
Time frame: 7 months
PD-L1, PD-1
Concentration of PD-L1, PD-1,
Time frame: 7 months
Existence of Biomarkers
PD-L1, Nectin2, HVEM
Time frame: 4 months