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A Randomized, Double-Blind, Placebo-controlled Study of the Efficacy & Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects With Chemorefractory Metastatic Colorectal Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer, Colorectal Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-controlled Study of the Efficacy & Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects With Chemorefractory Metastatic Colorectal Cancer

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.

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

- Known allergic reaction to monoclonal antibody therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

after 107 subjects have experienced disease progression or died prior to exhibiting disease progression

Outcome Time Frame:

16 wks after last patient enrolled

Safety Issue:


Principal Investigator

John Heyburn

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

November 2013

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Cancer
  • mCRC
  • chemorefractory metastatic colorectal cancer
  • Colorectal Neoplasms



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