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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00944905
First received: July 22, 2009
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Renal Cell Carcinoma
Non-hodgkin's Lymphoma
Biological: MDX-1203
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD) [ Time Frame: up to 17 cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biomarker: Incidence of CD70+ tumors in target population [ Time Frame: Screening ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: July 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00944905     History of Changes
Other Study ID Numbers: MDX1203-01, CA211-001
Study First Received: July 22, 2009
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014