This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
once weekly iv dosing for 4 weeks
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, United States
University Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Safety and tolerance of different dose levels
Time frame: 12 weeks
Lack of immunogenicity
Time frame: 8 and 12 weeks
Pharmacodynamics
Time frame: over 12 weeks
Pharmacokinetics
Time frame: over 12 weeks
Efficacy
Time frame: 4, 8 and 12 wks, every 3 months
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