A Study of of MORAb-004 in Subjects With Solid Tumors
|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.
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|