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Brief Title: A Study of Oncolytic Virus Injection (RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer
Official Title: A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of Oncolytic Virus Injection (RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer
Study ID: NCT05205421
Brief Summary: This is a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01.
Detailed Description: This is an investigator initiated , single-arm, open-label clinical pharmacology study of RT-01 as a single agent given via Intravenous injection in Patients With Extensive-Stage Small Cell Lung Cancer. RT-01 will be administered as a single dose on day 1 in patients with advanced solid tumors. Durvalumab will be administered intravenously every 3 weeks starting on day 5 after RT-1 on day 1 for 4 cycles,then followed by every 4 weeks. This study is planned to enroll 10-20 patients with Extensive-Stage Small Cell Lung Cancer. Considering the benefits of the subjects, the investigator deems that higher doses can be explored, then a higher-dose cohort will be carried out. The purpose of this study is to assess the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
First Affiliated Hospital Bengbu Medical College, Bengbu, Anhui, China