A Study of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor in Patients With Advanced Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Biological: Oncolytic Virus Injection(RT-01)

Detailed Description

This is an investigator initiated , single-arm, open-label study of RT-01 as a single agent given via Intravenous injection（IV）with or without Intratumoral injection（IT） in combination with IV Nivolumab in patients with advanced solid tumors.

This study is planned to enroll 40-50 patients with advanced solid tumors. RT-01 will be administered as a single dose on day 1, Nivolumab will be administered intravenously every 3 weeks starting on day 5.

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 in combination with PD-1 Inhibitor (Nivolumab).

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Han Zhengxiang, MD; Phone Number: 18052268612; Email: cnhzxyq@163.com

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221006
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
      • Contact: Han Zhengxiang, MD; Phone Number: 18052268612; Email: cnhzxyq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged ≥ 18 years;
• Subjects must have histologically or cytologically confirmed diagnosis of advanced solid tumor(s) who have failed in standard therapy (disease progression or intolerance) and no effective treatment, or have no standard therapy, or have failed to obtain standard treatment due to objective conditions ;
• Subjects have At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
• ECOG score of 0 ~ 2;
• Adequate bone marrow, hepatic and renal and coagulation function;
• Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
• Voluntarily participated in this study, signed the informed

Exclusion Criteria:

• Subjects with known brain metastasis and/or clinically history tumor brain of metastasis；
• Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 2 weeks before RT-01 administration；
• Subjects who have participate in another interventional study within 4 weeks before RT-01 administration；
• Subjects who have had major surgery within 4 weeks before RT-01 administration；
• Patients in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before RT-01 administration, but currently or previously treated with any of the following steroid regimens, were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; Prophylactic short-term use of corticosteroids；
• Subjects who have participate in another oncolytic virus study within 8 weeks before RT-01 administration；
• Subjects received live vaccines within 7 days before RT-01 administration；
• Subjects received Antiviral drugs within 2 weeks, long-acting interferon within 4 weeks before RT-01 administration；
• Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia);
• Subjects who have uncontrolled active infection;
• Subjects with known positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS);
• Subjects who have active hepatitis;
• Subjects who have serious cardiovascular system disorders history;
• Subjects with active autoimmune diseases or history of autoimmune diseases that may relapse;
• Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
• Subjects in other conditions that are considered unsuitable for this study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oncolytic Virus Injection(RT-01); RT-01 will be administered either intravenously or with a combination of intravenously and intratumorally on day 1. Nivolumab will be administered intravenously every 3 weeks starting on day 5.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Graded according to the NCI CTCAE version 5.0.	Up to 6 months
Objective response rate	Assess the proportion of patients who achieved complete or partial response	Up to 2 years
Disease control rate	Assess the proportion of patients who achieved complete or partial or stable response	Up to 2 years
The changes from baseline of lymphocyte counts	The changes from baseline of Peripheral blood lymphocyte subtypes counts	Up to 28 days
The Tmax of Viral RNA in blood	Time to peak viral RNA concentration	Up to 22 Weeks
The Cmax of Viral RNA in blood	The peak viral RNA concentration	Up to 22 Weeks
The concentration of antiviral antibody.	The concentration of antiviral antibody of RT-01 in blood	Up to 22 Weeks
The rate of subjects with viral shedding of RT-01	The rate of subjects with viral RNA in the secretion	Up to 22 Weeks

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: immunotherapy; RT-01; Oncolytic Virus; Intratumoral injection; Intravenous Injection; immune Checkpoint Inhibitors; PD-1 Inhibitor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LWY21076CXY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No