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)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Renal Cell Carcinoma; Non-hodgkin's Lymphoma

Treatments: Biological: MDX-1203

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944905

CA211-001 (Other Identifier)

MDX1203-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

MDX-1203

Experimental group

Description:

Accelerated titration design (ATD)of 6 dose levels. Subjects will be assigned to a dose level in the order they enter the study

Treatment:

Biological: MDX-1203