RecruitingPhase 1Phase 2NCT06008925

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


Sponsor

CNBG-Virogin Biotech (Shanghai) Ltd.

Enrollment

43 participants

Start Date

Nov 17, 2022

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of VG161 (an experimental virus-based therapy injected directly into tumors) plus nivolumab (a standard immunotherapy drug) for people with advanced or metastatic stomach or gastroesophageal cancer that has stopped responding to prior treatments, including immunotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced stomach or gastroesophageal junction cancer - You have already tried and failed at least two treatment regimens, including an anti-PD-1 immunotherapy drug - You have at least one tumor large enough to inject (over 1.5 cm) that can be reached with ultrasound guidance - You have tested positive for herpes simplex virus type 1 (HSV-1) antibodies - You are in reasonably good health (ECOG 0–1) **You may NOT be eligible if...** - You have uncontrolled or untreated brain metastases - Your organ function (liver, kidneys, heart) is significantly impaired - You are pregnant or breastfeeding - You have active serious infections or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))

Intratumoral injection only. Dosing days may be Day 1 or Days 1-3 only.

DRUGNivolumab Injection

Administered once at 3 mg/kg intravenously on Days 8 and 22 of each cycle.


Locations(1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06008925


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