A Study of Intratumoral Administration of Oncolytic Virus Injection (RT-01) in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title: A Single-Arm, Open-Label, Dose Escalation Study to Evaluate Safety and Efficacy of Intratumoral Injection of Oncolytic Virus Injection (RT-01) in Patients With Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

This is a single-arm, open-label, dose escalation, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) When Administered Via Intratumoral Injection in patients with advanced solid tumors. The primary purpose of this study is to evaluate the safety and tolerability, the secondary purpose is to evaluate the antitumor activity, immunoreactivity, immunogenicity, pharmacokinetics and virus shedding of RT-01.

Clinical Trial Description

This is an investigator initiated , single-arm, open-label, dose escalation clinical pharmacology study of RT-01 as a single agent given via Intratumoral injection in patients with advanced solid tumors. The study is a single agent dose escalation which will use an accelerated and "3+3" design to evaluate escalating doses of RT-01. Total enrollment will depend on the toxicities and/or activity observed, with approximately 6-12 evaluable participants enrolled. A Dose-Limiting Toxicity (DLT) observation period of 4 weeks was established before the entry of the first patient at the next dose level. ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

• NCT number: NCT05205408
• Study type: Interventional
• Source: First Affiliated Hospital Bengbu Medical College
• Contact: zhou huan, MD
• Phone: 13665527160
• Email: zhouhuanbest@163.com
• Status: Recruiting
• Phase: Phase 1
• Start date: February 24, 2022
• Completion date: June 2024