A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors
MORAb-004 is a monoclonal antibody directed against endosialin, a cell surface glycoprotein,
which is expressed on cells involved in tumor vasculature. Studies have found endosialin to
play a key role in tumor growth and neovessel formation in numerous cancer types including
(but not limited to) renal, breast, colon, pancreatic, lung, endometrial, ovarian, melanoma,
sarcoma, and neuroectodermal tumors. Preclinical pharmacological studies have shown that
MORAb-004 is a potentially useful anti-cancer agent. This clinical trial is being performed
to determine the safety of MORAb-004 in subjects with solid 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-004. Study Part 2 was added to enroll subjects with
specific histological diagnoses (colorectal cancer and soft tissue sarcoma) to further
characterize the safety and tolerability of 5 dose levels of MORAb-004 previously tested
during the dose escalation in Part 1.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety of multiple intravenous infusions of MORAb-004
Safety is evaluated by clinical assessment, monitoring of adverse events, laboratory evaluations, ECG.
Weekly while receiving study drug
Yes
Susan Weil, MD
Study Director
Morphotek, Inc.
United States: Food and Drug Administration
MORAb-004-001
NCT00847054
March 2009
October 2013
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |