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
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Cmax of Viral RNA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The Cmax of Viral RNA
时间窗: Up to 24 Weeks
The maximum RNA peak concentration
To evaluate the immunogenicity of RT-01
时间窗: Up to 28 days
Antiviral antibody
To evaluate the antitumor activity
时间窗: Up to 2 years
To assessed per RECIST and iRECIST
To evaluate the viral shedding of RT-01
时间窗: Up to 24 Weeks
Viral RNA
The changes of the immunoreactivity during treatment.
时间窗: Up to 28 days
Peripheral blood T lymphocyte subtype
Incidence of adverse events
时间窗: Up to 6 months
Graded according to the NCI CTCAE version 5.0.
The Tmax of Viral RNA
时间窗: Up to 24 Weeks
The time of maximum RNA peak concentration
次要结局
未报告次要终点
研究者
Wang Zishu
Director of the Department of Medical Oncology
First Affiliated Hospital Bengbu Medical College