NCT06008925

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: CNBG-Virogin Biotech (Shanghai) Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Part1(Phase Ib primary objective): To evaluate the safety and tolerability of VG161 administered by intratumoral injection combined with Nivolumab Injection in the treatment of patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (including anti-PD-1 monoclonal antibodies), explore the most suitable recommended Phase II dose (RP2D) for combination therapy, and determine the recommended regimen for combination therapy in Phase IIa clinical trials. Secondary objectives: 1) To preliminarily evaluate the antitumor activity of VG161 combined with nivolumab injection in the treatment of patients with advanced gastric cancer; 2) To monitor the changes of immunological parameters related to pharmacodynamics; 3) To evaluate the relevant immunological characteristics of tumor biopsy samples; 4) To evaluate the pharmacokinetic (PK) characteristics and viral excretion of single and multiple intratumoral injections of VG161; Part2(Phase IIa Primary Objective): To further evaluate the safety and efficacy of intratumoral injection of VG161 combined with nivolumab injection in patients 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), with the primary outcome measure of efficacy being objective response rate (ORR). Secondary objectives: 1) To evaluate the secondary outcome measures of the efficacy of combined treatment; 2) To monitor the pharmacodynamic-related changes in immunological parameters; 3) To evaluate the relevant immunological characteristics of tumor biopsy samples;

Conditions

• Metastatic Gastric Cancer

Interventions

Type	Name	Description
DRUG	Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))	Intratumoral injection only. Dosing days may be Day 1 or Days 1-3 only.
DRUG	Nivolumab Injection	Administered once at 3 mg/kg intravenously on Days 8 and 22 of each cycle.

Timeline

• Start date: 2022-11-17
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2023-08-24
• Last updated: 2023-08-24

Locations

1 site across 1 country: China