NCT00944905

Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma (ccRCC) or Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Renal Cell Carcinoma
• Non-hodgkin's Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	MDX-1203	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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2009-07-23
• Last updated: 2013-05-22

Locations

5 sites across 1 country: United States