Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled anti-ED-B mAbs SPECT imaging in patients with ED-B 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 177Lu-labeled anti-ED-B mAbs and will undergo SPECT/CT scanning to determine uptake of 177Lu-labeled anti-ED-B mAbs 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 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, and be able to complete the trial according to the requirement of the scheme;
- •Aged 18-75, male or female;
- •Patients diagnosed with solid tumors confirmed by histopathology ;
- •Patients with biopsy-proven fibronectin ED-B positive;
- •At least one measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
- •ECOG score 0~2;
- •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
177Lu-Anti-ED-B mAbs
Patients will receive a tracer (5 mg, IV) dose of 177Lu (10 mCi) labeled anti-ED-B mAbs(177Lu-B5-IgG4)
干预措施: 177Lu-B5-IgG4 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 1 year
Safety will be assessed by evaluation of incidence of adverse events.
Evaluation of tissue distribution of 177Lu-Anti-ED-B mAbs(B5-IgG4)
时间窗: 1 year
Biodistribution of 177Lu-Anti-ED-B mAbs(B5-IgG4) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 177Lu-SPECT scans will be reported.
Dosimetry estimates of 177Lu-Anti-ED-B mAbs(B5-IgG4)
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.
次要结局
未报告次要终点
研究者
Chunjing Yu
Director
Affiliated Hospital of Jiangnan University