NCT05136937

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Wuxi People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor
• Advanced Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Oncolytic Virus Injection(RT-01)	Administered by intratumoral injection for 3 dose cohorts: 1×10\^7 TCID50/mL, 1×10\^8 TCID50/mL and 7×10\^8 TCID50/mL

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-06-01
• Completion: 2023-06-01
• First posted: 2021-11-30
• Last updated: 2022-01-31

Locations

1 site across 1 country: China