NCT07185243

A Study to Evaluate Combination Therapy of Oncolytic Vaccinia Virus (hV01) and PD-1 Inhibitor in Advanced Solid Tumors.

A Study Evaluating the Safety and Efficacy of hV01, a Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus, in Combination With the PD-1 Inhibitor Tislelizumab for Advanced Solid Tumors.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Hangzhou Converd Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and primary efficacy of the combination therapy of recombinant human IL-21-expressing oncolytic vaccinia virus (hV01) and the PD-1 Inhibitor Tislelizumab in patients with advanced solid tumors.

Detailed description

This study is divided into two parts and follows a single-arm design. Part A evaluates the safety and tolerability of hV01 administration at two different frequencies: twice per 28-day cycle (on days 1 and 3) and three times per 28-day cycle (on days 1, 3, and 5). The study will adhere to the 3+3 principle for monitoring dose-limiting toxicity (DLT). Part B assesses the combination of hV01 and Tislelizumab. This phase will involve multiple administrations of hV01 (either twice or three times per 42-day cycle), followed by the administration of Tislelizumab on days 14 and 35. Monitoring for DLTs will also be conducted for the first 3 or 6 subjects in this phase. Efficacy will be evaluated using the RECIST v1.1 criteria.

Conditions

• Advanced Solid Tumors

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: 2025-06-23
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: China