NCT03638804Unknown不适用
89Zr-labeled KN035 PET Imaging in Patients With PD-L1positive Advanced Solid Tumors
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年11月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans
研究概览
简要总结
This is a single arm study by using 89Zr-labeled KN035 (89Zr-KN035) PET imaging to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors.
详细描述
The overall purpose of the study is to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors by using PET imaging. Safety will be observed after 89Zr-KN035 injection, and radiation dosimetry of 89Zr-KN035 will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily signed informed consent;
- •Age 18-75, male or female;
- •Patients diagnosed with locally advanced or metastatic solid tumors by histopathology or cytology;
- •Patients with biopsy-proven PD-L1 positive;
- •ECOG score ≤ 0~1; Life expectancy of at least 3 months;
- •Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects.
排除标准
- •Currently or within the first 28 days before the first dose to participate in another therapeutic clinical trial. If participating in a non-interventional clinical trial, it is not be excluded.
- •Patients with systemic or locally severe infections (CTCAE ≥ 2);
- •Patients with allergies or allergies to any component of the imaging agent or antibody;
- •Patients who cannot undergo PET/CT imaging;
- •Intolerance of intravenous administration, as well as difficulties in venous blood collection (If having the medical history of fainting during acupuncture, and blood phobia);
- •Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmia;
- •Patients have significant QT/QTC interval prolongation during the screening period;
- •Received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose;
- •Patents have not recovered to CTCAE grade 0 or 1 from the adverse events due to cancer therapeutics administered;
- •Previously received CD137 agonist or immune checkpoint blocking therapy;
- •Patients with diabetes who have a fasting blood glucose greater than 10 mmol/L;
- •HIV antibody positive, active hepatitis B/C, and TB positive;
- •Patients are regular users (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol);
- •Patients with symptomatic ascites, pleural effusion, or hydropericardium;
- •Pregnant or lactating women, or planning to become pregnant or have children during this trial.
结局指标
主要结局
Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans
时间窗: 6 months
次要结局
- Number of adverse events as assessed by CTCAE v4.03(6 months)
- Number of changes in vital signs as accessed by CTCAE v4.03(6 months)
- Number of changes in laboratory test results as accessed by CTCAE v4.03(6 months)
研究者
Miao Liyan
Professor
The First Affiliated Hospital of Soochow University
研究点 (1)
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