Dose Escalation Study MORAb-066 Targeting TF-expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
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|ClinicalTrials.gov Identifier: NCT01761240|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Pancreatic Cancer Colorectal Cancer Non-small-cell Lung Cancer NSCLC Adenocarcinoma||Drug: MORAb-066||Phase 1|
-To evaluate the safety and tolerability of weekly intravenous (IV) infusions of MORAb-066.
- To identify the dose-limiting toxicities (DLT) and to determine the maximum tolerated dose (MTD) of MORAb-066.
- To characterize the pharmacokinetic (PK) properties of MORAb-066.
- To identify, on the basis of safety, PK, and pharmacodynamics (PDx) data, a recommended Phase II dose and schedule for MORAb-066.
- To make a preliminary assessment of the antitumor activity of MORAb-066.
- To detect any antibody response (i.e., human antihuman antibodies [HAHA]) to multiple IV infusions to MORAb-066.
- To evaluate the presence of tissue factor (TF) substrates such as protease activated receptor 2 when applicable.
- To evaluate the archived tumor tissue for TF overexpression by immunohistochemistry.
- To evaluate whether there are potential biomarkers that correlate responses to MORAb-066.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the Safety, Tolerability, and PK of MORAb-066, a Humanized Monoclonal Antibody to Human TF, in Patients With Advanced or Metastatic Breast, Pancreatic, Colorectal, or NSCLC (Adenocarcinoma) Malignancies|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||July 2016|
|Experimental: Study Drug||
- Maximum Tolerated Dose [ Time Frame: 24 Months ]
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): NCT01761240
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States|
|United States, Tennessee|
|Nashville, Tennessee, United States|
|Principal Investigator:||Johanna Bendell, MD||SCRI Development Innovations, LLC|
|Principal Investigator:||Kathleen Moore, MD||Oklahoma University|