A Study of of MORAb-004 in Subjects With Solid Tumors
The purpose of this study is to determine the safety of multiple intravenous infusions of MORAb-004.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors|
- To determine the safety of multiple intravenous infusions of MORAb-004 [ Time Frame: Weekly while receiving study drug ] [ Designated as safety issue: Yes ]Safety is evaluated by clinical assessment, monitoring of adverse events, laboratory evaluations, ECG.
- To determine the maximum tolerated dose (MTD) of MORAb-004 (within the administered range) [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]Monitoring of adverse events, laboratory test results and ECG results.
- To determine optimal biologic dose (OBD) of MORAb-004 [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]Monitoring of adverse events, laboratory evaulations and ECG results.
- To establish the serum pharmacokinetics of MORAb-004 using a validated assay [ Time Frame: Weekly ] [ Designated as safety issue: No ]Serial serum PK evaluations.
- To describe changes in the objective measurements of tumor size and biomarkers (if applicable)after treatment with MORAb-004 [ Time Frame: bimonthly ] [ Designated as safety issue: No ]CT or MRI evaluations following every other 4-week cycle.
- To detect any antibody response (human anti-human antibodies [HAHA] to multiple intravenous infusions of MORAb-004 [ Time Frame: Biweekly ] [ Designated as safety issue: Yes ]Biweekly serum collection for detection of HAHA during treatment.
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Drug: MORAb-004 (monoclonal antibody to TEM1)
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.
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21205|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Director:||Susan Weil, MD||Morphotek, Inc.|