Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma, Non-hodgkin's Lymphoma

Thank you

Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)

Outcome Time Frame:

up to 17 cycles

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

MDX1203-01

NCT ID:

NCT00944905

Start Date:

July 2009

Completion Date:

November 2012

Related Keywords:

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

Name

Location

Yale University School Of MedicineNew Haven, Connecticut  06520
The University of ChicagoChicago, Illinois  60637
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Emory University Winship Cancer CenterAtlanta, Georgia  30322
The University of Michigan Health SystemAnn Arbor, Michigan  48109