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)

May 21, 2013 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Winship Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Greenebaum Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • The University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)
Time Frame: up to 17 cycles
up to 17 cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
Biomarker: Incidence of CD70+ tumors in target population
Time Frame: Screening
Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX1203-01
  • CA211-001 (Other Identifier: BMS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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