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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. ;

Study Design

Related Conditions & MeSH terms

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

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