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A Clinical Study of Intratumoral Administration of RT-01 in Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:
An Open-Label, Dose Escalation Study of the Safety and Tolerability of Oncolytic Virus Injection(RT-01) When Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors

Clinical Trial Summary

This is an open-label, dose escalation study of the safety and tolerability of oncolytic virus injection(RT-01) when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of RT-01 and to determine the recommended phase 2 dose (RP2D) for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of RT-01.

Clinical Trial Description

This is an investigator initiated , open-label, study of RT-01 given via intratumoral (IT) injection as a single agent in participants with advanced solid tumors. The study is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of RT-01. Total enrollment will depend on the toxicities and/or activity observed, with approximately 7-18 evaluable participants enrolled. The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of RT-01 as a single agent. Secondary objectives will assess efficacy overall response rate, as well as disease control rate, progression free survival, duration of response, and anti-tumor immune responses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05136937
Study type Interventional
Source Wuxi People's Hospital
Contact Peihua Lu, MD
Phone +86 13621500031
Email 13625653@qq.com
Status Recruiting
Phase Phase 1
Start date November 1, 2021
Completion date June 1, 2023
View Details
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