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

Last updated: April 8, 2022
Sponsor: Morphotek
Overall Status: Terminated

Phase

2

Condition

Colon Cancer

Rectal Cancer

Metastatic Cancer

Treatment

N/A

Clinical Study ID

NCT01507545
MORAb-004-202-CRC
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 daysprior to the first treatment infusion
  • Be willing and able to provide written informed consent

Exclusion

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 6months
  • Known allergic reaction to monoclonal antibody therapy

Study Design

Total Participants: 154
Study Start date:
March 27, 2012
Estimated Completion Date:
October 20, 2013

Study 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.

Connect with a study center

  • Central Hem/Onc Medical Group, Inc.

    Alhambra, California 91801
    United States

    Site Not Available

  • Comprehensive Blood and Cancer Center

    Bakersfield, California 93309
    United States

    Site Not Available

  • Providence St. Joseph Medical Center-Disney Family Cancer Center

    Burbank, California 91505
    United States

    Site Not Available

  • St. Jude Heritage Healthcare

    Fullerton, California 92835
    United States

    Site Not Available

  • The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical Center

    Northridge, California 91328
    United States

    Site Not Available

  • UC Davis Comprehensive Cancer Center

    Sacramento, California
    United States

    Site Not Available

  • Sharp Memorial Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • CPMCRI / Pacific Hematology Oncology Associates

    San Francisco, California 94115
    United States

    Site Not Available

  • Central Coast Medical Oncology

    Santa Maria, California 93454
    United States

    Site Not Available

  • UCLA Hematology Oncology

    Santa Monica, California 90404
    United States

    Site Not Available

  • Colorado Cancer Research Program

    Denver, Colorado 80224
    United States

    Site Not Available

  • St. Mary's Hospital Regional Cancer Center

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • Lutheran Hematology & Oncology

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Christiana Care Health Services

    Newark, Delaware 19713
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Integrated Community Oncology Network / Cancer Specialists of North Florida

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Mayo Clinic Florida Hematology/Oncology

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Compass Research, LLC

    Orange City, Florida 32763
    United States

    Site Not Available

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida 34952
    United States

    Site Not Available

  • Hematology Oncology Associates of the Treasure Coast

    Port St. Lucie, Florida 34952
    United States

    Site Not Available

  • Cancer Care Centers of Brevard

    Rockledge, Florida 32955
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center (Moffitt Cancer Center)

    Tampa, Florida 33612
    United States

    Site Not Available

  • Suburban Hematology-Oncology Associates, P.C.

    Duluth, Georgia 30096
    United States

    Site Not Available

  • Suburban Hematology-Oncology Assoc., PC

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Suburban Hematology-Oncology Associates, P.C.

    Snellville, Georgia 30078
    United States

    Site Not Available

  • Medical and Surgical Specialists

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Ingalls Cancer Research Center

    Harvey, Illinois 60426
    United States

    Site Not Available

  • Oncology Specialists,S.C. Center for Advanced Care

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Illinois CancerCare, P.C.

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Medical Oncology & Hematology Associates (Clinic #3)

    Clive, Iowa 50325
    United States

    Site Not Available

  • Iowa Oncology Research Association

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology & Hematology Associates (Clinic #1)

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology & Hematology Associates (Clinic #2)

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Cancer Center of Kansas

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Central Baptist Hospital

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • John Hopkins University

    Baltimore, Maryland 21231-1000
    United States

    Site Not Available

  • Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Lahey Clinic

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Essentia Health Duluth CCOP

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Coborn Cancer Center/ CentraCare Health Plaza

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • Metro Minnesota CCOP

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Regions Hospital

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • St. John's Hospital

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Coborn Cancer Center/ CentraCare Health Plaza

    St. Cloud, Minnesota 56303
    United States

    Site Not Available

  • CCCN

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Presbyterian Hospital Cancer Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Piedmont Hematology Oncology Associates PA

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Piedmont Hematology Oncology Associates PA

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Medcenter One

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • TriHealth Oncology Institute/Oncology Partners Network

    Cincinnati, Ohio 45247
    United States

    Site Not Available

  • Hickman Cancer Center at Flower Hospital

    Sylvania, Ohio 43560
    United States

    Site Not Available

  • Mercy Cancer Center

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Pharma Resource

    East Providence, Rhode Island 02915
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • St. Mary's Hospital / Green Bay Oncology

    Green Bay, Wisconsin 54303
    United States

    Site Not Available

  • St. Vincent Hospital / Green Bay Oncology

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

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