Clinical Trials

Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)

Location:

Trial status:

Open for Enrollment

Why is this study being done?

Colorectal cancer is the third most common new cancer diagnosis by 2011 estimates and, by far, the most common digestive system cancer. The number of anticipated new cases in 2011 in the US is 141,210, being equally distributed between men and women. Tumor endothelial marker-1 also referred to as TEM-1 is expressed in the supportive tissue, as well as, on the cells within the tumor. TEM-1, which is a cell surface glycoprotein, and is expressed in the stromal compartment (cells) of nearly all human tumors. In preclinical studies, it has been shown that TEM-1 plays a key role in tumor growth and the vascularization of tumors. There is evidence suggesting an association between the level of TEM-1, 7, 7R, 8 in relation to lymph node involvement and disease progression. MORAb-004 is a humanized immunoglobulin G (IgG1/κ) antibody directed against endosialin/TEM-1. Nonclinical pharmacological studies showed that MORAb-004 has the ability to block specific TEM-1 receptor-ligand interactions. Immunohistochemistry studies of human tumor biopsy samples demonstrate TEM-1 expression and MORAb-004 binding to tumor stromal cells, in particular mural cell compartment of neovessels and cancer-associated fibroblasts. All of which suggests a potential effective treatment. Researchers hypothesize that an antibody therapy which binds to TEM-1 may be efficacious in the treatment of metastatic, colorectal cancer. This clinical trial is a proof of concept study to see if an anti-TEM-1 agent is safe and effective in the treatment of metastatic, colorectal cancer.

Who is eligible to participate?

Inclusion Criteria:

- Males and females >18 years old

- Diagnosis of metastatic, colorectal cancer

- Significant medical conditions must be well-controlled and stable for at least 30 days prior to the first treatment infusion

- Be willing and able to provide written informed consent

Exclusion Criteria:

- No prior treatment for metastatic colorectal cancer

- Other serious systemic diseases (bacterial or fungal)

- Clinically significant heart disease or an arrhythmia on an ECG within the past 6 months

- Known allergic reaction to monoclonal antibody therapy

Last updated: 05/17/2013

NCT ID: NCT01507545

IRB Number:11-008274