NCT07006077

Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Pancreatic Cancer

A Phase II Trial to Evaluate the Efficacy of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Patients With Advanced Pancreatic Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Hangzhou Converd Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this clinical trial is to preliminary evaluate the efficacy of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced pancreatic cancer.And the secondary purpose is to evaluate the safety of hV01.

Detailed description

This is a single-site, single-arm, open-label,exploratory phase Ⅱa study. Based on the safety results of the completed phase I clinical trial of hV01 , 8.0x10 \^ 8 PFU was selected as a dose level of the dosage for each administration in this clinical trial, hV01 will be administered with twice per cycle (on day 1 and day 15), efficacy evaluation will be conducted on day 28, and every 28 days as a treatment cycle,during which safety will be observed.

Conditions

• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant human IL-21-expressing oncolytic vaccinia virus injection	hV01 is a recombinant vaccinia virus with deletions of the viral thymidine kinase (TK) and viral growth factor (VGF) genes and insertion of the human IL-21 gene.

Timeline

• Start date: 2025-05-29
• Primary completion: 2028-12-31
• Completion: 2029-03-05
• First posted: 2025-06-05
• Last updated: 2026-02-27

Locations

1 site across 1 country: China