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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 Intravenous 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 and in combination with IV PD-1/PD-L1 in participants with advanced solid tumors. The study consists of two parts:In the single agent dose escalation part (Part A), four doses (1×10^7 TCID50, 1×10^8 TCID50, 3×10^8 TCID50, 1×10^9 TCID50) of RT-01 will be delivered Intravenous as single agent to observe the DLTs and to identify the MTD. Part A is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of RT-01. Once the IV RT-01 MTD is established, the Part B part of the study will begin. Part B is IV RT-01 in combination with IV PD-1/PD-L1 dose escalation which will use a 3+3 design to evaluate escalating doses of IV RT in combination with IV pembrolizumab. Total enrollment will depend on the toxicities and/or activity observed, with approximately 16-36 evaluable participants enrolled. The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of Intravenous administration of RT-01 as a single agent and in combination with immune checkpoint inhibitors. 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


NCT number NCT05122572
Study type Interventional
Source Wuxi People's Hospital
Contact Peihua Lu, MD
Phone +86 13621500031
Email [email protected]
Status Recruiting
Phase Phase 1
Start date November 1, 2021
Completion date June 1, 2023

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