Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer
A Dose Ascending, Open Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of VG161 Combined With Nivolumab Injection in Subjects With Metastatic Gastric Cancer
CNBG-Virogin Biotech (Shanghai) Ltd.
43 participants
Nov 17, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Intratumoral injection only. Dosing days may be Day 1 or Days 1-3 only.
Administered once at 3 mg/kg intravenously on Days 8 and 22 of each cycle.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06008925