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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00847054
First received: February 5, 2009
Last updated: July 15, 2014
Last verified: July 2014

February 5, 2009
July 15, 2014
March 2009
April 2014   (final data collection date for primary outcome measure)
To determine the safety of multiple intravenous infusions of MORAb-004 [ Time Frame: Weekly while receiving study drug ] [ Designated as safety issue: Yes ]
Safety is evaluated by clinical assessment, monitoring of adverse events, laboratory evaluations, ECG.
To determine the safety of multiple intravenous infusions of MORAb-004
Complete list of historical versions of study NCT00847054 on ClinicalTrials.gov Archive Site
  • To determine the maximum tolerated dose (MTD) of MORAb-004 (within the administered range) [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
    Monitoring of adverse events, laboratory test results and ECG results.
  • To determine optimal biologic dose (OBD) of MORAb-004 [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
    Monitoring of adverse events, laboratory evaulations and ECG results.
  • To establish the serum pharmacokinetics of MORAb-004 using a validated assay [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    Serial serum PK evaluations.
  • To describe changes in the objective measurements of tumor size and biomarkers (if applicable)after treatment with MORAb-004 [ Time Frame: bimonthly ] [ Designated as safety issue: No ]
    CT or MRI evaluations following every other 4-week cycle.
  • To detect any antibody response (human anti-human antibodies [HAHA] to multiple intravenous infusions of MORAb-004 [ Time Frame: Biweekly ] [ Designated as safety issue: Yes ]
    Biweekly serum collection for detection of HAHA during treatment.
  • To determine the maximum tolerated dose (MTD) of MORAb-004 (within the administered range)
  • To determine dose limiting toxicities (DLT) of MORAb-004 (within the administered range)
  • To establish the serum pharmacokentics of MORAb-004 using a validated assay
  • To describe changes in the objective measurements of tumor size and biomarkers (if applicable)after treatment with MORAb-004
  • To detect any antibody response (human anti-human antibodies [HAHA] to multiple intravenous infusions of MORAb-004
Not Provided
Not Provided
 
A Study of of MORAb-004 in Subjects With Solid Tumors
A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor
Drug: MORAb-004 (monoclonal antibody to TEM1)
Intravenous administration
Experimental: MORAb-004
Intervention: Drug: MORAb-004 (monoclonal antibody to TEM1)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00847054
MORAb-004-001
No
Morphotek
Morphotek
Not Provided
Study Director: Susan Weil, MD Morphotek, Inc.
Morphotek
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP