NCT05815394招募中早期 1 期
177Lu-labeled NY108 SPECT Imaging in Patients
Affiliated Hospital of Jiangnan University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年3月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)
研究概览
简要总结
This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily signed informed consent;
- •Age 18-75, male;
- •Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis;
- •Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive;
- •Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen;
- •Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria;
- •An ECOG score of 0-2
排除标准
- •Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
- •Patients with severe systemic or localized infections or other serious coexisting diseases;
- •Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc;
- •Patients with autoimmune diseases, including rheumatoid, etc;
- •Inadequately controlled arrhythmias, including atrial fibrillation:
- •Cardiac insufficiency (New York Heart Association (NYHA) work class criteria);
- •Uncontrolled hypertension;
- •Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies;
- •Subjects positive for syphilis, HBV, HCV, FIIV;
- •Subjects of childbearing age who are unable to use effective contraceptive devices:
- •Patients with a history of mental illness or related medical conditions;
- •Patients who are unable or unavailable for SPECT/CT scanning;
- •Other subjects who, in the opinion of the investigator, are not suitable for enrollment.
研究组 & 干预措施
177Lu-Anti-PSMA mAbs
Experimental
干预措施: 177Lu-labeled NY108 (Drug)
结局指标
主要结局
Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)
时间窗: 1 year
Biodistribution of 177Lu-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 177Lu-SPECT scans will be reported.
Incidence of Treatment-Emergent Adverse Events
时间窗: 1 year
Safety will be assessed by evaluation of incidence of adverse events.
次要结局
未报告次要终点
研究者
Chunjing Yu
Director
Affiliated Hospital of Jiangnan University
研究点 (1)
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