Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET-CT Imaging in Patients With CLDN18.2 Positive Solid Tumors
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
- Dosimetry estimates of 89Zr-Anti-CLDN18.2 mAbs (NY005).
研究概览
简要总结
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled anti-CLDN18.2 mAbs (89Zr-NY005) PET imaging in patients with CLDN18.2 positive solid tumors.
详细描述
After being fully 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 anti-CLDN18.2 mAbs(89Zr-NY005) and will undergo PET/CT scanning to determine uptake of 89Zr-NY005 in tumor lesions and normal tissues and organs.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily signed informed consent, and be able to complete the trial according to the requirement of the scheme;
- •Aged 18-80, male or female;
- •The clinical diagnosis was gastric cancer, esophageal cancer and pancreatic cancer;
- •Patients with biopsy-proven CLDN18.2 positive;
- •Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
- •At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
- •ECOG score ≤ 0~3; Life expectancy of at least 3 months;
- •ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit.
- •Other routine examinations are within the normal range or considered acceptable by the researchers.
排除标准
- •Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
- •Patients with systemic or locally severe infections, or other serious coexisting diseases;
- •Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
- •Patients with autoimmune diseases, including rheumatoid arthritis;
- •Inadequate control of arrhythmias, including atrial fibrillation;
- •Uncontrolled hypertension;
- •Patients with allergies or allergies to any component of the imaging agent or antibody;
- •Patients who cannot undergo PET/CT imaging scan;
- •Syphilis, HBV, HCV, or HIV positive subjects;
- •Male and female subjects of reproductive age cannot take effective contraceptive measures;
- •Pregnant or lactating women;
- •Patients with a history of mental illness or related conditions;
- •Other subjects considered unsuitable by researchers.
研究组 & 干预措施
89Zr-NY005 injection
Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3 mCi) labeled anti-CLDN18.2 mAbs (89Zr-NY005)
干预措施: 89Zr-NY005 (Drug)
结局指标
主要结局
Dosimetry estimates of 89Zr-Anti-CLDN18.2 mAbs (NY005).
时间窗: 1 year
Absorbed dose (radioactive uptake) estimates for different organs and tissues calculated with the AUCs and the OLINDA/EXM dosimetry program will be obtained and reported.
Evaluation of tissue distribution of 89Zr-Anti-CLDN18.2 mAbs(NY005)
时间窗: 1 year
Biodistribution of 89Zr-Anti-CLDN18.2 mAbs (NY005) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 89Zr-PET scans will be reported.
Pharmacokinetic analysis of 89Zr-Anti-CLDN18.2 mAbs (NY005).
时间窗: 1 year
Area under the radioactivity (SUVs) versus time (time from injection) curve (AUC) will be derived by integration and reported. Other pharmacokinetic parameters including peak radioactive uptake (Cmax) and time (Tmax) in different organs, clearance and volume of distribution, evaluated using a biexponential model and non-compartmental analysis, will be reported.
次要结局
未报告次要终点