NCT05162118

Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer

Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of VG161 in Combination With Nivolumab in Patients With Advanced Pancreatic Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This is a multicenter, open, single-arm design clinical trial coducted in HSV-seropositive subjects with advanced pancreatic cancer to determine the safety, tolerability and preliminary efficacy of VG161 combined with PD-1 inhibitor (Nivolumab Injection).

Detailed description

A multicenter, open, single-arm design of clinical trial of VG161 in combined with PD-1 inhibitor (Nivolumab) in the treatment of patients with advanced pancreatic cancer with metastasis. The standard 3 + 3 design was used in the dose-finding study to explore the safety of the combination treatment, determine the recommended safe dose (RP2D) of the combination treatment in the second phase of efficacy study. The first cycle was observed until Day 28, i.e., DLT observation period. In the efficacy investigation trial, Simon two-segment design was used to continue to investigate the preliminary efficacy of the combination at a safe dose.

Conditions

• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) in combination with Nivolumab	Intratumoral injection of VG161 on day 1 only or day 1 through 3, in combination of Nivolumab intravenous injection only, Once every 2 weeks, 3 mg/kg each time.

Timeline

• Start date: 2022-03-08
• Primary completion: 2025-03-22
• Completion: 2025-12-22
• First posted: 2021-12-17
• Last updated: 2022-03-09

Locations

1 site across 1 country: China