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)

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00944905

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

9.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma Non-hodgkin's Lymphoma	Biological: MDX-1203	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

46 participants

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD) [up to 17 cycles]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine	New Haven	Connecticut	United States	06520
2	Emory University Winship Cancer Center	Atlanta	Georgia	United States	30322
3	The University of Chicago	Chicago	Illinois	United States	60637
4	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
5	The University of Michigan Health System	Ann Arbor	Michigan	United States	48109