At a glance
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NCT06008925Phase 2RecruitingUpdate OverdueUpdated 34mo ago · Completion was 6mo agoA 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
In Brief
A Phase 2 clinical trial evaluating Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) and Nivolumab Injection for Metastatic Gastric Cancer. Currently recruiting, targeting 43 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
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.