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Safety and Efficacy of Recombinant Oncolytic Adenovirus L-IFN Injection in Relapsed/Refractory Solid Tumors Clinical Study — YSCH-01  

Breast Cancer Clinical Trial

Official title:
Safety and Efficacy of Recombinant L-IFN Adenovirus Injection in Relapsed/Refractory Solid Tumors: a Single/Multicenter, Dose-increasing, Cohort Extension Clinical Study

Clinical Trial Summary

This is an open-label, dose escalation study of the safety and tolerability of Recombinant oncolytic adenovirus L-IFN injection（YSCH-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 Recombinant L-IFN adenovirus injectionand to determine the recommended phase 1 dose for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of Recombinant L-IFN adenovirus injection

Clinical Trial Description

This is an investigator initiated , open-label, study of Recombinant oncolytic adenovirus L-IFN injection 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 Recombinant L-IFN adenovirus injection. Total enrollment will depend on the toxicities and/or activity observed, with approximately19-28 evaluable participants enrolled. The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of Recombinant oncolytic adenovirus L-IFN injection 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 NCT05180851
Study type Interventional
Source Shanghai Fengxian District Central Hospital
Contact Rong Zhang, MD
Phone 86-13818868345
Email rongzhang@163.com
Status Recruiting
Phase Early Phase 1
Start date November 30, 2021
Completion date December 31, 2023
View Details
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