A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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.
United States: Food and Drug Administration
|National Cacner Institue||Bethesda, Maryland 20892`|