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MDX-010

Phase 1

Human Immunodeficiency Virus (HIV) | Monoclonal antibody | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jan 23, 2018

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03407105A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)PHASE1 COMPLETED 24 — — Apr 21, 2003Feb 21, 2006Jan 23, 20185 United States
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Study Endpoints
Primary Endpoints
Number of treatment induced dose limiting toxicities (DLTs)
Up to 141 days
Grade of treatment induced DLTs
Up to 141 days
Number of treatment emergent AEs (adverse events)
Up to 141 days
Secondary Endpoints
Maximum plasma concentration observed post-dose (Cmax)
Up to 141 days
Time of maximum plasma concentration observed post-dose (Tmax)
Up to 141 days
HIV Ribonucleic Acid (RNA) level
Up to 141 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 2EXPERIMENTALSpecified dose on specified days
Interventions
NameTypeDescription
MDX-010BIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Detectable HIV viremia (HIV-1 RNA level between 1,000 and 100,000 copies/mL) * CD4 count greater than or equal to 100 cells/mm3 * Current antiretroviral therapy regimen following at least 2 previous changes for documented virologic failure * Documented resistance tests demonst...

Countries:United States
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