NCT05122572Unknown1 期
An Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravenous With and Without Intratumoral Oncolytic Virus Injection (RT-01) Combined With or Without Immune Checkpoint Inhibitors (Nivolumab) in the Treatment of Patients With Advanced Solid Tumors
Wuxi People's Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities (DLT)
研究概览
简要总结
This is a single-arm, open-lable study to determine the safety, tolerability and preliminary efficacy of oncolytic virus injection (RT-01) combined with or without immune checkpoint inhibitors (Nivolumab) in the treatment of patients with advanced solid tumors.
详细描述
To evaluate the safety, tolerability, efficacy, immunoreactivity, immunogenicity, pharmacokinetics and virus shedding of RT-01 injection given via Intravenous with or without Intratumoral administration combined with immune checkpoint inhibitors Nivolumab in the treatment of patients with advanced solid tumors.
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;
- •Have a histopathologically or cytologically confirmed dagnosis of advanced solid tumors and no existing options are felt to provide clinical benefit;
- •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 cardiovascular 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;
- •Ability to provide written informed consent.
排除标准
- •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 4 weeks；
- •Subjects who have participate in another interventional study while receiving study IP within 4 weeks；
- •Subjects who have had major surgery ≤ 4 weeks of dosing；
- •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 prior to investigational drug 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 (≤ 7 days) use of corticosteroids (e.g., allergy to contrast media) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity caused by contact allergens)；
- •Subjects received live vaccines within 7 days of initiation of study treatment；
- •Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia)；
- •Subjects who have any 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
Dose Limiting Toxicities (DLT)
时间窗: Up to 28 days
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Defined as the highest safety-tolerated dose level where at most one patient out of six experiences dose limiting toxicities (DLT) with the next higher dose level having at least 2 of 6 patients who have experienced DLT.
次要结局
- Viral replication and shedding in blood, urine and buccal swabs(Up to 6 months)
- Incidence of adverse events(Up to 6 months)
- Disease Control Rate (DCR)(Up to 6 months)
- Overall response rate (ORR)(Up to 6 months)
- Overall Survival (OS)(Up to 6 months)
- Progression Free Survival (PFS)(Up to 6 months)
研究者
研究点 (1)
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