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) - Full Text View

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 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Renal Cell Carcinoma B-cell Lymphoma Clear Cell Renal Cell Carcinoma

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

Biomarker: Incidence of CD70+ tumors in target population [ Time Frame: Screening ]


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 (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

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:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site


Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00944905 History of Changes
Other Study ID Numbers:	MDX1203-01 CA211-001 ( Other Identifier: BMS )
Study First Received:	July 22, 2009
Last Updated:	May 21, 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

ClinicalTrials.gov processed this record on September 21, 2017