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)

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944905
• Other study ID #: MDX1203-01
• Secondary ID: CA211-001
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2009
• Last updated: May 21, 2013
• Start date: July 2009
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-hodgkin's Lymphoma
• Renal Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Michigan Health System	Ann Arbor	Michigan
United States	Emory University Winship Cancer Center	Atlanta	Georgia
United States	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland
United States	The University of Chicago	Chicago	Illinois
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)		up to 17 cycles	Yes
Secondary	Biomarker: Incidence of CD70+ tumors in target population		Screening	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm