Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
Background: * Amatuximab is a high-affinity monoclonal IgG antibody raised against human mesothelin. * Mesothelin is a glycosyl-phosphatidyl inositol-linked membrane glycoprotein thought to be involved in tumor metastasis * Mesothelin is over-expressed in many cancers Objectives: -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. Eligibility: * Female or male subjects greater than or equal to 18 years of age; * Histologically confirmed mesothelin-expressing cancer; * Transaminases less than or equal to 3 times ULN for mesothelioma, non small cell lung and ovarian cancer; * Transaminases less than or equal to 5 times ULN for pancreatic cancer with known liver metastasis. Design: * This is a single-center, single-dose, open-label, pilot study of MORAb-009 in approximately 20 subjects with mesothelin expressing tumors. * Indium-radiolabeled MORAb-009 (5mCi) will be administered. * Serial single photon emission-computerized tomography imaging will be performed to determine binding to tumor and nontumor tissue. * Subjects will be observed closely for safety and possible development of anti-MORAb-009 antibodies. * Pharmacokinetics of radiolabeled antibody will be determined with imaging over time.
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
