The purpose of this study is to determine if MDX-1203 is safe for the treatment of renal cell carcinoma or non-hodgkin's lymphoma.
Multicenter, open-label, dose-escalation, multidose study of MDX-1203, a fully human monoclonal antibody drug conjugate targeting the CD70 transmembrane cell-surface protein which is highly expressed in ccRCC and B-NHL. MDX-1203 is composed of a human anti-CD70 monoclonal antibody covalently linked to a prodrug form of a cytotoxic deoxyribonucleic acid (DNA) minor-groove binding agent (MGBA). The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 17 cycles or 2 years), and Follow-up (up to 6 months).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Assigned Interventions: Single dose of MDX-1203 will be administered every 21 days as an intravenous (i.v.) infusion. Subjects will receive one dose of MDX-1203.
Yale University School of Medicine
New Haven, Connecticut, United States
Emory University Winship Cancer Center
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)
Time frame: up to 17 cycles
Biomarker: Incidence of CD70+ tumors in target population
Time frame: Screening
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The University of Michigan Health System
Ann Arbor, Michigan, United States