A Study of Oncolytic Virus Injection (RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Biological: Oncolytic Virus Injection(RT-01)


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oncolytic Virus Injection(RT-01)<br>RT-01 will be administered by intravenously; | Biological: Oncolytic Virus Injection(RT-01)<br>* Intravenous injection a single dose of RT-01<br>|

What is the study measuring?
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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 | 
| To evaluate the antitumor activity | To assessed per RECIST and iRECIST | Up to 2 years | 
| The changes of the immunoreactivity during treatment. | Peripheral blood T lymphocyte subtype | Up to 28 days | 
| To evaluate the immunogenicity of RT-01 | Antiviral antibody | Up to 28 days | 
| To evaluate the viral shedding of RT-01 | Viral RNA | Up to 24 Weeks | 
| The Cmax of Viral RNA | The maximum RNA peak concentration | Up to 24 Weeks | 
| The Tmax of Viral RNA | The time of maximum RNA peak concentration | Up to 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-L1 Inhibitor, RT-01, Oncolytic Virus, immunotherapy, Intravenous Injection, Small-cell lung cancer