A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Morphotek
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue
研究概览
简要总结
This research is being conducted to determine the biodistribution of radiolabeled amatuximab in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or non small cell lung cancer.
详细描述
The primary objective is to determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissues in subjects with mesothelin over-expressing cancers including mesothelioma, pancreatic, ovarian, and non small cell lung cancer. This is a single-center, single-dose, open-label, pilot study of amatuximab in approximately 20 subjects with mesothelin expressing tumors. 111Indium-radiolabeled amatuximab (5 mCi) will be administered. Serial SPECT imaging (at 3 specific time points up to 196 hours after cold infusion) will be performed to determine binding to tumor and nontumor tissue. Subjects will be observed closely for safety and possible development of anti-amatuximab antibodies. Pharmacokinetics of radiolabeled antibody will be determined with imaging over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and Male subjects > or = 18 years of age
- •Histologically confirmed mesothelin-expressing cancer
- •Measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is > or = 1.5cm, as defined by RECIST v1.1 and disease location, at discretion of the physician, or evaluable by clinical symptoms supported by biomarker, radiological or pathological studies conducted within 4 weeks prior to study entry
排除标准
- •Known allergy or hypersensitivity to monoclonal antibodies
- •Known to develop HACA
- •Prior treatment with amatuximab
- •Prior treatment with SS1 (dsFv)PE38 (ss1P)
- •Prior treatment with another test article within previous 30 days
- •Known brain metastasis
- •Known prosthetic devices that would prohibit imaging ow lesion of interest due to radiographic artifact
- •Chemotherapy, biological therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab
研究组 & 干预措施
Amatuximab infusion
Subjects will receive one infusion of radiolabeled amatuximab.
干预措施: Amatuximab (Drug)
结局指标
主要结局
Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue
时间窗: 1 year
To determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissue in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or nonsmall cell lung cancer by performing SPECT imaging to determine binding to tumor and non-tumor tissue.
次要结局
- Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab(1 year)
- Pharmacokinetic and serum levels(1 year)
- uptake of Indium-CHX-A amatuximab(1 year)
- occurrence of HACA(1 year)
- correlate shed serum mesothelin to imaging(1 year)