NCT05644509

Study on the Treatment of Advanced Malignant Solid Tumor With Revottack and PD-1 Inhibitor

A Clinical Pharmacological Study of Intravenous Administration of Vesicular Stomatitis Oncolytic Virus Injection (Revottack）Combined PD-1 Inhibitor in Patients With Advanced Malignant Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with advanced malignant solid tumors. The purpose of this study is to evaluate the safety, tolerability, anti-tumor activity, immunogenicity, immune response, pharmacokinetic (PK) characteristics and shedding characteristics of Revottack injection combined with PD-1 inhibitor in patients with advanced solid tumors.

Detailed description

This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with advanced malignant solid tumors. This study is planned to enroll 6-10 patients with advanced solid tumors. Subjects will receive the administration of revottack and PD-1( Toripalimab)inhibitor at a given time. The purpose of this study is to evaluate the safety, tolerability, anti-tumor activity, immunogenicity, immune response, pharmacokinetic (PK) characteristics and shedding characteristics of Revottack injection combined with PD-1 inhibitor in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Oncolytic Virus Injection（Revottack）+PD-1	Intravenous injection of Revottack injection combined with PD-1(Toripalimab） inhibitor

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-12-09
• Last updated: 2022-12-09

Locations

1 site across 1 country: China