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A Study of of MORAb-004 in Subjects With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00847054
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine the safety of multiple intravenous infusions of MORAb-004.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: MORAb-004 (monoclonal antibody to TEM1) Phase 1

Detailed Description:
MORAb-004 is a monoclonal antibody directed against endosialin, a cell surface glycoprotein, which is expressed on cells involved in tumor vasculature. Studies have found endosialin to play a key role in tumor growth and neovessel formation in numerous cancer types including (but not limited to) renal, breast, colon, pancreatic, lung, endometrial, ovarian, melanoma, sarcoma, and neuroectodermal tumors. Preclinical pharmacological studies have shown that MORAb-004 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the safety of MORAb-004 in subjects with solid tumors, as well as to establish serum pharmacokinetics of the antibody, and to assess tumor antigens that may serve as predictors of a response to MORAb-004. Study Part 2 was added to enroll subjects with specific histological diagnoses (colorectal cancer and soft tissue sarcoma) to further characterize the safety and tolerability of 5 dose levels of MORAb-004 previously tested during the dose escalation in Part 1.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors
Study Start Date : March 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MORAb-004 Drug: MORAb-004 (monoclonal antibody to TEM1)
Intravenous administration

Primary Outcome Measures :
  1. To determine the safety of multiple intravenous infusions of MORAb-004 [ Time Frame: Weekly while receiving study drug ]
    Safety is evaluated by clinical assessment, monitoring of adverse events, laboratory evaluations, ECG.

Secondary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) of MORAb-004 (within the administered range) [ Time Frame: Weekly ]
    Monitoring of adverse events, laboratory test results and ECG results.

  2. To determine optimal biologic dose (OBD) of MORAb-004 [ Time Frame: Weekly ]
    Monitoring of adverse events, laboratory evaulations and ECG results.

  3. To establish the serum pharmacokinetics of MORAb-004 using a validated assay [ Time Frame: Weekly ]
    Serial serum PK evaluations.

  4. To describe changes in the objective measurements of tumor size and biomarkers (if applicable)after treatment with MORAb-004 [ Time Frame: bimonthly ]
    CT or MRI evaluations following every other 4-week cycle.

  5. To detect any antibody response (human anti-human antibodies [HAHA] to multiple intravenous infusions of MORAb-004 [ Time Frame: Biweekly ]
    Biweekly serum collection for detection of HAHA during treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects ≥18 years of age.
  • Subjects with any malignant solid tumor without intracranial involvement or metastases diagnosed by standard pathology criteria that has failed standard chemotherapy.
  • Subject must have disease, as defined by RECIST or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
  • Karnofsky performance status ≥70%.
  • Female subjects of childbearing potential and all male subjects must consent to use a medically acceptable method of contraception throughout the study period and for 30 days after MORAb-004 administration. A barrier method of contraception must be included.
  • Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows: Absolute neutrophil count (ANC) ≥1.5 x 109/L; Platelet count ≥100 x 109/L; Hemoglobin ≥10 g/dL; Serum bilirubin ≤2.0 mg/dL; Aspartate transaminase (AST) ≤2.5 x ULN; or ≤5 x ULN if liver metastases are present; Alanine transaminase (ALT) ≤2.5 x ULN; or ≤5 x ULN if liver metastases are present; Serum creatinine ≤2.0 mg/dL; prothrombin time (PT) and aPTT within institutional limits of normal.
  • Subject must be willing and able to provide written informed consent.
  • In Part 2 (expansion cohorts) ONLY, subjects must have a histological diagnosis of either CRC or STS (and subtypes, excluding bone sarcomas).

Exclusion Criteria:

  • Known central nervous system (CNS) tumor involvement or metastases.
  • Evidence of other active malignancy.
  • Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
  • Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
  • Presence of severe lung disease (In the absence of clinically apparent severe lung disease, no formal testing is necessary. In the presence of clinically severe lung disease, FEV1 must be >60% in order for the subject to be eligible.)
  • Active serious systemic disease, including active bacterial or fungal infection.
  • Chronic inflammatory disorder, e.g., inflammatory bowel disease, active vasculitis.
  • Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to enrollment.
  • Breast-feeding, pregnant, or likely to become pregnant during the study.
  • Active hepatitis or human immunodeficiency virus (HIV) infection.
  • Subjects who have received a previous monoclonal antibody therapy and have evidence of an immune or allergic reaction, or previously documented human anti-human antibody (HAHA).
  • Subjects with large ascites or pleural effusion (≥500 cc) based on results of most recent CT scan).
  • Chronic systemic anticoagulation therapy with warfarin or heparin

Information from the National Library of Medicine

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 identifier (NCT number): NCT00847054

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United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21205
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
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Study Director: Susan Weil, MD Morphotek
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Responsible Party: Morphotek Identifier: NCT00847054    
Other Study ID Numbers: MORAb-004-001
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Morphotek:
Solid Tumor
Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs