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90Y-hLL2

Phase 1

NHL | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 16, 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 Enrollment59
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00421395Safety Study of NHL With 90Y-hLL2 IgGPHASE1 COMPLETED 59 — — Aug 1, 2002Oct 1, 2007Aug 16, 20215 France, Germany
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Study Endpoints
Primary Endpoints
Safety will be evaluated from physical examinations, hematology and chemistry testing and toxicity evaluation
First 12 weeks, total 5 years
Secondary Endpoints
Determine maximum tolerated dose (MTD)
first 12 weeks
Evaluate the immunogenicity and safety of repeated infusions of 90Y-hLL2 in NHL patients.
6 weeks, 12 weeks, every 3 months if HAHA elevated
Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.
6 wks, 12 wks, every 3 mos for 5 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
multiEXPERIMENTALescalating in increments of 2.5 mCi/m2
Interventions
NameTypeDescription
90Y-hLL2BIOLOGICALweekly dosing for either 2 or 3 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * All patients must have a histologic or cytological diagnosis of B-cell lymphoma, and have failed at least one regimen of standard chemotherapy. All histologic grades of non-Hodgkin's lymphoma (NHL) will be eligible for these studies. * Patients must be \> 18 years of age * Mea...

Countries:FranceGermany
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