A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
- 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
-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.
- 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
- 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
- Pharmacokinetics of radiolabeled antibody will be determined with imaging over time.
Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Biodistribution of radiolabelled amatuximab in tumor and nontumor tissues.
Raffit Hassan, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|