The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Massachusetts General Hospital Mass Gen 3
Boston, Massachusetts, United States
Cancer Institute of New Jersey SC
New Brunswick, New Jersey, United States
Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson
Philadelphia, Pennsylvania, United States
University of Utah / Huntsman Cancer Institute Huntsman 3
Salt Lake City, Utah, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Modena, MO, Italy
Novartis Investigative Site
Barcelona, Catalonia, Spain
Incidence rate of Dose Limiting Toxicity
Time frame: 4 weeks
LFA102 serum concentration
Time frame: 6 months
Disease response
Time frame: every 2 to 3 months
Concentrations of antibodies to LFA102
Time frame: every month
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