This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first.
Site Reference ID/Investigator# 70400
Los Angeles, California, United States
Site Reference ID/Investigator# 70401
New York, New York, United States
Site Reference ID/Investigator# 70399
Cleveland, Ohio, United States
The proportion of patients with a confirmed tumor response at any time during the study
Time frame: Any time during the study
Time to disease progression
Time frame: Up to 104 weeks
Duration of tumor response
Time frame: Up to 104 weeks
Pharmacokinetics (PK) of M200
Time frame: Day 0 through Study Termination
Immunogenicity
Time frame: Day 0 through Study Termination
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