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MDX-1401

Phase 1

Hodgkin's Lymphomas | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Trials Updated: Dec 6, 2012

MDX-1401 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

MDX-1401 clinical trials

MDX-1401 · 1 trial · 1 indication

Phase 1 1
NCT00634452Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's LymphomaHodgkin's Lymphomas
COMPLETED22 Analytics
PHASE1COMPLETED
Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
Hodgkin's LymphomasUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability Profile
Two years

Secondary Endpoints

Objective Response Rate (ORR)
Day 50
Tumor response assessment
Two year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MDX-1401EXPERIMENTALMDX-1401 iv at various doses

Interventions

NameTypeDescription
MDX-1401BIOLOGICALIV weekly for 4 weeks
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry * Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant * Bi-measurable disease * ECOG Performance Status of 0 - 2 * Meet...

Countries:United States
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Frequently asked questions about MDX-1401

What is MDX-1401?

MDX-1401 is an investigational monoclonal antibody developed by Bristol-Myers Squibb for the treatment of Hodgkin's lymphoma. It was studied in a Phase 1 clinical trial in patients with CD30-positive refractory or relapsed Hodgkin's lymphoma. It is not an approved therapy and remains in clinical development.

What is MDX-1401 used for in Hodgkin's lymphoma?

MDX-1401 was studied as a treatment for CD30-positive refractory or relapsed Hodgkin's lymphoma. The Phase 1 trial enrolled patients with this condition, including adolescents as young as 12 years old. It is an investigational agent and has not been approved for any use.

Who makes MDX-1401?

MDX-1401 is 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 antibody in Hodgkin's lymphoma.

What phase is MDX-1401 in?

MDX-1401 is in Phase 1 development. A single Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not received FDA approval.

What clinical trials is MDX-1401 in?

MDX-1401 was evaluated in one Phase 1 clinical trial, NCT00634452, titled "Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma." The trial enrolled 22 patients in the United States and is now completed. It was an uncontrolled study without randomization or blinding.