NCT04977128Unknown不适用
Safety Study of 89Zr-labeled KN035 PET Imaging in Patients With PD-L1 Positive Solid Tumors
Wuxi No. 4 People's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the safety of 89Zr-KN035 in PD-L1 positive solid tumor patients
研究概览
简要总结
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled KN035 (89Zr-KN035) PET Imaging in patients with PD-L1 positive solid tumors.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-KN035 and will undergo PET/CT scanning to determine uptake of 89Zr-KN035 in tumor lesions.
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 solid tumors confirmed by histopathology or cytology;
- •At least one measurable solid lesion has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
- •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;
- •Patients need to receive other anti-tumor treatments during the trial period；
- •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.
研究组 & 干预措施
Experimental：89Zr-KN035 injection
Experimental
Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035)
干预措施: 89Zr-KN035 (Drug)
结局指标
主要结局
To evaluate the safety of 89Zr-KN035 in PD-L1 positive solid tumor patients
时间窗: 1 year
Safety will be assessed by evaluation of incidence of adverse events
次要结局
- Biodistribution of 89Zr-KN035(1 year)
- Correlation 89Zr-KN035 uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry(1 year)
- Evaluation of immunotherapy efficacy(1 year)
研究者
研究点 (1)
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