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

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

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

Key facts

Study ID

NCT00847054

Run by

Morphotek

People needed

80

Starts

2009-03-01

Expected to finish

2014-04-01

Last updated by the study team

2014-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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