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

Morphotek

Status and phase: Terminated; Phase 2

Conditions: Metastatic Colorectal Cancer; Colorectal Cancer

Treatments: Drug: Placebo; Drug: MORAb-004; Other: Best supportive care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01507545

MORAb-004-202-CRC

Details and patient eligibility

About

The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.

Full description

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 that binds to TEM-1 may be efficacious in the treatment of metastatic, colorectal cancer. This clinical study 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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups, including a placebo group

MORAb-004

Active Comparator group

Treatment:

Other: Best supportive care

Drug: MORAb-004

Placebo

Placebo Comparator group

Treatment:

Other: Best supportive care

Drug: Placebo