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90Y-hPAM4

Phase 1

Pancreatic Cancer | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 19, 2021

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 Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00597129Safety and Efficacy Study of 90Y-hPAM4 at Different DosesPHASE1 COMPLETED 21Aug 1, 2004Oct 1, 2007Aug 19, 20214 United States
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Study Endpoints
Primary Endpoints
safety MTD
over the first 12 weeks, then over 2 years
Secondary Endpoints
targeting, biodistribution, organ dosimetry
first 2 weeks
pharmacokinetics (PK), antigenicity,
first 12 weeks
efficacy
over first 12 weeks, then over 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Multi Dose levelsEXPERIMENTALdifferent doses of 90YhPAM4 will be given only once.
Interventions
NameTypeDescription
90Y-hPAM4BIOLOGICALSingle dose of 90Y-hPAM4 will be given and all patients will be followed for 12 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Male or female patients, \>18 years of age, who are able to understand and give written informed consent. * Histologically or cytologically confirmed, Stage III or IV pancreatic adenocarcinoma. * Patients with Stage III (locally advanced) disease must have documented progressi...

Countries:United States
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