A Study of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor in Patients With Advanced Solid Tumors
NCT05228119 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2022-05-09
Summary
This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in combination with PD-1 inhibitor (Nivolumab) in patients with advanced solid tumors.
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 in combination with PD-1 inhibitor.
Conditions
- Advanced Solid Tumor
Interventions
- BIOLOGICAL
-
Oncolytic Virus Injection(RT-01)
Intravenous injection with or without intratumoral injection of a single dose of RT-01 and intravenous infusion of Nivolumab
Sponsors & Collaborators
-
The Affiliated Hospital of Xuzhou Medical University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-04
- Primary Completion
- 2022-10-01
- Completion
- 2023-10-01
Countries
- China
Study Locations
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