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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Subjects will receive one infusion of radiolabeled amatuximab.
National Cacner Institue
Bethesda, Maryland, United States
Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue
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.
Time frame: 1 year
Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab
To determine the safety of a single IV of Indium-CHX-A amatuximab by collecting safety data during/ after the infusions as well as obtain any potential drug-related AEs 30 days post infusion
Time frame: 1 year
Pharmacokinetic and serum levels
To determine the PK parameters of the Indium-CHX-A amatuximab with imaging, and serum levels collected over time
Time frame: 1 year
uptake of Indium-CHX-A amatuximab
To explore the uptake of Indium-CHX-A amatuximab with mesothelin tumor expression as determined by ICH
Time frame: 1 year
occurrence of HACA
To tabulate the occurrence of HACA which will be measured through serum samples collected over time
Time frame: 1 year
correlate shed serum mesothelin to imaging
To correlate shed serum mesothelin to imaging obtained after antibody administration.
Time frame: 1 year
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