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MDX-1203

Phase 1

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

MDX-1203 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

MDX-1203 clinical trials

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 CarcinomaUnlock trial analytics

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 was studied for the treatment of advanced or recurrent clear cell renal cell carcinoma and relapsed or refractory B-cell non-Hodgkin's lymphoma. It is an oncology drug candidate that was evaluated in a single Phase 1 clinical trial. It is not an approved therapy.

Who is developing MDX-1203?

MDX-1203 was developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 study of the drug in renal cell carcinoma and non-Hodgkin's lymphoma.

What phase is MDX-1203 in?

MDX-1203 is in Phase 1 development. It has been evaluated in one completed Phase 1 clinical trial that enrolled 46 participants. The trial was uncontrolled, non-randomized, and not double-blinded. No active trials of MDX-1203 are currently listed.

What clinical trial was MDX-1203 studied in?

MDX-1203 was studied in the Phase 1 trial NCT00944905, titled 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). The trial was conducted in the United States, enrolled 46 participants aged 18 years and older, and has been completed.

Is MDX-1203 FDA approved?

MDX-1203 is not approved by the FDA. It is an investigational monoclonal antibody that has completed a single Phase 1 clinical trial in renal cell carcinoma and non-Hodgkin's lymphoma. No regulatory approval has been granted for this drug candidate.

Was MDX-1203 studied in biomarker-selected patients?

Yes, the Phase 1 trial of MDX-1203, NCT00944905, was biomarker-selected, meaning participants were enrolled based on specific biomarker criteria. The study evaluated the drug in adults with advanced or recurrent clear cell renal cell carcinoma or relapsed or refractory B-cell non-Hodgkin's lymphoma.