OncoMatch/Clinical Trials/NCT06008925
Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer
Is NCT06008925 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 and Nivolumab for metastatic gastric cancer.
Treatment: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
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
Cannot have received: chemotherapy
Exception: within 4 weeks before the first use of the study drug
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
Cannot have received: oral fluorouracil
Exception: within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer)
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)
Cannot have received: small molecule targeted drugs
Exception: within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer)
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)
Cannot have received: other unmarketed clinical trial treatment
Exception: within 4 weeks before the first dose of study drug
received other unmarketed clinical trial treatment within 4 weeks before the first dose of study drug
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L, PLT ≥ 100 × 10^9/L, Hb ≥ 85 g/L, lymphocyte count ≥ 1.5 × 10^9/L (for lymphocyte count 0.8 × 10^9/L to 1.5 × 10^9/L, the investigator judged whether to enroll)
Kidney function
Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml/min (Cockcroft-Gault formula)
Liver function
TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN
Cardiac function
QTc interval > 480 ms, NYHA functional classification ≥ II or LVEF < 40%, acute coronary syndrome, congestive heart failure, stroke or other Grade III or higher cardiovascular events within 6 months, uncontrolled hypertension after treatment
adequate organ function: 1) blood routine (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC ≥ 1.5 × 10^9/L, PLT ≥ 100 × 10^9/L, Hb ≥ 85 g/L, lymphocyte count ≥ 1.5 × 10^9/L (for lymphocyte count 0.8 × 10^9/L to 1.5 × 10^9/L, the investigator judged whether to enroll); 2) liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN; 3) renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml/min (calculated according to Cockcroft-Gault formula); 4) coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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