VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This is a multicenter, open, single-arm design clinical trial coducted in HSV-seropositive subjects with advanced pancreatic cancer to determine the safety, tolerability and preliminary efficacy of VG161 combined with PD-1 inhibitor (Nivolumab Injection).
A multicenter, open, single-arm design of clinical trial of VG161 in combined with PD-1 inhibitor (Nivolumab) in the treatment of patients with advanced pancreatic cancer with metastasis. The standard 3 + 3 design was used in the dose-finding study to explore the safety of the combination treatment, determine the recommended safe dose (RP2D) of the combination treatment in the second phase of efficacy study. The first cycle was observed until Day 28, i.e., DLT observation period. In the efficacy investigation trial, Simon two-segment design was used to continue to investigate the preliminary efficacy of the combination at a safe dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Intratumoral injection of VG161 on day 1 only or day 1 through 3, in combination of Nivolumab intravenous injection only, Once every 2 weeks, 3 mg/kg each time.
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGMTD
MTD (Maximum tolerable dose)
Time frame: 1 month
Occurrence and numbers of DLT (phase 1)
Occurence of DLT (Dose Limiting Toxicity) and numbers of DLT
Time frame: 1 month
Occurence and frequence of AE and SAE (phase 1)
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Time frame: 24 month
DCR (phase 2)
Evaluate Disease Control Rate by RECIST 1.1
Time frame: 24 month
RP2D (phase 1)
RP2D (Recommended dose for phase II)
Time frame: 1 month
DCR (phase 1)
Evaluate Disease Control Rate by RECIST 1.1
Time frame: 24 month
ORR
Evaluate Objective Response Rate by RECIST 1.1
Time frame: 24 month
PFS
Evaluate Progression Free Survival by RECIST 1.1
Time frame: 24 month
PD-1
PD-1 level in peripheral blood T cells
Time frame: 24 month
Single cell sequencing
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Single-cell sequencing of tumor biopsy samples
Time frame: 24 month
Occurence and frequence of AE and SAE (phase 2)
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Time frame: 24 month
CD3+
Concentration of CD3+
Time frame: 24 month
CD4+
Concentration of CD4+
Time frame: 24 month
CD8+
Concentration of CD8+
Time frame: 24 month
CD4+/CD8+
Concentration of CD4+/CD8+
Time frame: 24 month
NK
Concentration of NK
Time frame: 24 month
CD19+
Concentration of CD19+
Time frame: 24 month
CD56+
Concentration of CD56+
Time frame: 24 month
IL-6
Cytokine levels of IL-6
Time frame: 24 month
TNF-a
Cytokine levels of TNF-a
Time frame: 24 month
IFN-γ
Cytokine levels of IFN-γ
Time frame: 24 month
CA19-9
Tumor markers of CA19-9
Time frame: 24 month
CA125
Tumor markers of CA125
Time frame: 24 month
CEA
Tumor markers of CEA
Time frame: 24 month