A Phase I, Multicenter, Open-Label, Dose-Escalation, Multidose Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma or Relapsed/Refractory B-Cell 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).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)
up to 17 cycles
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
MDX1203-01
NCT00944905
July 2009
November 2012
Name | Location |
---|---|
Yale University School Of Medicine | New Haven, Connecticut 06520 |
The University of Chicago | Chicago, Illinois 60637 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Emory University Winship Cancer Center | Atlanta, Georgia 30322 |
The University of Michigan Health System | Ann Arbor, Michigan 48109 |