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MDX-1203

Phase 1

Renal Cell Carcinoma | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: May 22, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

MDX-1203 · 1 trial · 2 indications

Phase 1 1
NCT00944905Study 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)Renal Cell Carcinoma
COMPLETED46 Analytics
PHASE1COMPLETED
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)
Renal Cell Carcinoma
NCT0094490546
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Biomarker: Incidence of CD70+ tumors in target population
Screening
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MDX-1203EXPERIMENTALAccelerated titration design (ATD)of 6 dose levels. Subjects will be assigned to a dose level in the order they enter the study

Interventions

NameTypeDescription
MDX-1203BIOLOGICALAssigned 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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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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 lymph...

Countries:United States
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Frequently asked questions about MDX-1203

What is MDX-1203 used for?

MDX-1203 is an investigational monoclonal antibody being studied for the treatment of advanced or recurrent clear cell renal cell carcinoma (ccRCC) and relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL). It is being developed by Bristol-Myers Squibb Company (NYSE: BMY).

Who makes MDX-1203?

MDX-1203 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research on this investigational monoclonal antibody for oncology indications.

What phase is MDX-1203 in?

MDX-1203 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 study of MDX-1203 has been completed, and the drug is no longer in active clinical trials.

What clinical trials is MDX-1203 in?

MDX-1203 was studied in a Phase 1 clinical trial with the identifier NCT00944905. This completed trial enrolled 46 participants with advanced or recurrent clear cell renal cell carcinoma or relapsed or refractory B-cell non-Hodgkin's lymphoma. The study was conducted in the United States.

Is MDX-1203 the same as any other drug?

MDX-1203 is an investigational monoclonal antibody developed by Bristol-Myers Squibb. No alternative names for this drug have been disclosed in the clinical trial record. It is being studied specifically for renal cell carcinoma and non-Hodgkin's lymphoma.