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MDX-1401

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00634452Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's LymphomaPHASE1 COMPLETED 22Feb 1, 2008Jan 1, 2010Dec 6, 20126 United States
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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 — 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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