Status:
COMPLETED
A Study of of MORAb-004 in Subjects With Solid Tumors
Lead Sponsor:
Morphotek
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of multiple intravenous infusions of MORAb-004.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00847054
Start Date
March 1 2009
End Date
April 1 2014
Last Update
July 16 2014
Active Locations (3)
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1
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21205
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111