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Brief Title: A Study of MORAb-009 in Subjects With Pancreatic Cancer, Mesothelioma, or Certain Types of Ovarian or Lung Cancer
Official Title: A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-009, a Chimeric Monoclonal Antibody, in Subjects With Advanced Mesothelin-expressing Tumors
Study ID: NCT00325494
Brief Summary: The purpose of this study is to establish the safest doses of an investigational drug called MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface of these cancers.
Detailed Description: MORAb-009 is a high-affinity monoclonal antibody raised against human mesothelin, a membrane glycoprotein thought to be involved in cell adhesion and tightly associated with a range of cancers. It has been shown that mesothelin is over-expressed in pancreatic cancers, mesotheliomas, and ovarian or mesothelin-expressing ovarian or non-small cell lung cancers, while showing little expression in normal tissues. Preclinical experiments indicate that MORAb-009 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the safety of MORAb-009 in subjects with mesothelin-expressing tumors, as well as to establish serum pharmacokinetics of the antibody, and to assess tumor antigens that may serve as predictors of a response to MORAb-009.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
National Cancer Institute, Bethesda, Maryland, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Name: Susan C. Weil, M.D.
Affiliation: Morphotek
Role: STUDY_DIRECTOR