Status:
COMPLETED
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)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Renal Cell Carcinoma
Non-hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Criteria specific to each tumor type:
- For Clear cell renal cell carcinoma (ccRCC): advanced or recurrent disease. Must have failed at least 1 prior systemic therapy
- For B-cell non-Hodgkin's lymphoma (B-NHL): Must have failed at least 1 prior systemic therapy
- Measurable disease criteria by tumor type:
- For ccRCC: At least 1 unidimensional measurable lesion
- For B-NHL: At least 1 bidimensionally measurable lesion
- Prior therapies for advanced/recurrent ccRCC or relapsed/refractory B-NHL or have become intolerant to a systemic therapy
- Provide archived or fresh tumor tissue for CD70 status. Subjects must be CD70+
- Provision of fresh tissue (pre-treatment and on-treatment) for exploratory analysis is mandatory for at least 5 and a maximum of 10 B-NHL subjects
Exclusion
- Prior therapy with an anti-CD70 antibody
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Active or untreated central nervous system lymphoma
- Active infection (viral, bacterial, or fungal)
- Evidence of bleeding diathesis or coagulopathy
- Active autoimmune disease requiring immunosuppressive therapy
- Known current drug or alcohol abuse
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00944905
Start Date
July 1 2009
End Date
November 1 2012
Last Update
May 22 2013
Active Locations (5)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
2
Emory University Winship Cancer Center
Atlanta, Georgia, United States, 30322
3
The University of Chicago
Chicago, Illinois, United States, 60637
4
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201