Non-hodgkin's Lymphoma, Renal Cell Carcinoma
Conditions
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).
Interventions
BIOLOGICALMDX-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.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD) | up to 17 cycles |
Secondary
| Measure | Time frame |
|---|---|
| Biomarker: Incidence of CD70+ tumors in target population | Screening |
Countries
United States
Outcome results
None listed