NCT05205408

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: The First Affiliated Hospital of Bengbu Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Oncolytic Virus Injection(RT-01)	Administered by intratumoral injection as single agent.

Timeline

• Start date: 2022-02-24
• Primary completion: 2023-06-01
• Completion: 2024-06-01
• First posted: 2022-01-25
• Last updated: 2022-11-29

Locations

1 site across 1 country: China