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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)

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ClinicalTrials.gov Identifier: NCT00944905
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Non-hodgkin's Lymphoma Biological: MDX-1203 Phase 1

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).


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2009
Primary Completion Date : November 2012
Study Completion Date : November 2012


Arms and Interventions

Arm Intervention/treatment
Experimental: MDX-1203
Accelerated titration design (ATD)of 6 dose levels. Subjects will be assigned to a dose level in the order they enter the study
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.


Outcome Measures

Primary Outcome Measures :
  1. Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD) [ Time Frame: up to 17 cycles ]

Secondary Outcome Measures :
  1. Biomarker: Incidence of CD70+ tumors in target population [ Time Frame: Screening ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944905


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Georgia
Emory University Winship Cancer Center
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Michigan
The University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00944905     History of Changes
Other Study ID Numbers: MDX1203-01
CA211-001 ( Other Identifier: BMS )
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Lymphoma
Carcinoma
Lymphoma, Non-Hodgkin
Carcinoma, Renal Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Glandular and Epithelial
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs