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)
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| ClinicalTrials.gov Identifier: NCT00944905 |
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Recruitment Status
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Completed
First Posted
: July 23, 2009
Last Update Posted
: May 22, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Renal Cell Carcinoma Non-hodgkin's Lymphoma | Biological: MDX-1203 | Phase 1 |
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 (Clinical Trial) |
| 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 : | July 2009 |
| Actual Primary Completion Date : | November 2012 |
| Actual Study Completion Date : | November 2012 |
| Arm | Intervention/treatment |
|---|---|
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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
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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.
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- Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD) [ Time Frame: up to 17 cycles ]
- Biomarker: Incidence of CD70+ tumors in target population [ Time Frame: Screening ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944905
| 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 | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00944905 History of Changes |
| Other Study ID Numbers: |
MDX1203-01 CA211-001 ( Other Identifier: BMS ) |
| First Posted: | July 23, 2009 Key Record Dates |
| Last Update Posted: | May 22, 2013 |
| Last Verified: | May 2013 |
Additional relevant MeSH terms:
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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 |