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)

Phase 1

Completed

• Conditions: Renal Cell Carcinoma; Non-hodgkin's Lymphoma
• Interventions: Biological: MDX-1203

• Registration Number: NCT00944905
• Lead Sponsor: Bristol-Myers Squibb

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 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDX-1203	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

Primary Outcome Measures

Name	Time	Method
Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)	up to 17 cycles

Secondary Outcome Measures

Name	Time	Method
Biomarker: Incidence of CD70+ tumors in target population	Screening

Trial Locations

Locations (5)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

The University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

University of Maryland Greenebaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Emory University Winship Cancer Center; 🇺🇸 Atlanta, Georgia, United States