A Study of of MORAb-004 in Subjects With Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00847054|
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: MORAb-004 (monoclonal antibody to TEM1)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors|
|Study Start Date :||March 2009|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
Drug: MORAb-004 (monoclonal antibody to TEM1)
- To determine the safety of multiple intravenous infusions of MORAb-004 [ Time Frame: Weekly while receiving study drug ]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 ]Monitoring of adverse events, laboratory test results and ECG results.
- To determine optimal biologic dose (OBD) of MORAb-004 [ Time Frame: Weekly ]Monitoring of adverse events, laboratory evaulations and ECG results.
- To establish the serum pharmacokinetics of MORAb-004 using a validated assay [ Time Frame: Weekly ]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 ]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 ]Biweekly serum collection for detection of HAHA during treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847054
|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|