VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies). This is an open-label study divided into two parts.
Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.
Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.
Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
aged 18 to 75 years (inclusive), male or female.
Patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology.
According to the Guidelines for the Diagnosis and Treatment of Gastric Cancer (CSCO, version 2021), patients must have previously failed two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies), or patients who cannot continue treatment due to severe adverse reactions as judged by the investigator.
received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, of which oral fluorouracil and small molecule targeted drugs were within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer).
received other unmarketed clinical trial treatment within 4 weeks before the first dose of study drug.
Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose of study drug.
Patients who have received systemic corticosteroids (prednisone > 10 mg/day or equivalent doses of the same class of drugs) or other immunosuppressive agents within 14 days before the first dose of study drug; except for the following: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term corticosteroids (≤ 10 mg prednisone equivalent) for prophylaxis (e.g., prevention of contrast agent allergy).
Single group
Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))
DrugIntratumoral injection only. Dosing days may be Day 1 or Days 1-3 only.
Nivolumab Injection
DrugAdministered once at 3 mg/kg intravenously on Days 8 and 22 of each cycle.
Phase Ib:RP2D/MTD
RP2D/MTD for VG161 in Combination with Nivolumab
Phase Ib:Incidence and number of DLT
Incidence and number of DLT (dose-limiting toxicity)
Phase Ib and Phase IIa:AE, SAE occurrence and frequency
Occurrence and frequency of AE (Adverse Event) and SAE（Serious adverse event)
Phase IIa:ORR
Objective response rate (ORR)
Phase Ib and Phase IIa:ORR and DCR
Objective response rate (ORR) and disease control rate (DCR)
Phase Ib and Phase IIa:PFSand OS
Progression Free Survival (PFS) and Overall Survival (OS)
Phase Ib and Phase IIa:DOR
Duration of Response (DOR)
Phase Ib and Phase IIa: Immunological indicators
Immunological parameters: peripheral blood lymphocyte subsets (CD3 +, CD4 +, CD8 +, CD4 +/CD8 + ratio, CD19 +, CD16 + CD56 + (NK) cells), cytokines (IL-12, IL-15, IL-6, TNF-α, IFN-γ);
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