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hA20-humanized anti-CD20 antibody

Phase 1

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 17, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment82
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00285428Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's LymphomaPHASE1 COMPLETED 82 — — Sep 1, 2004Oct 1, 2007Aug 17, 20213 United States
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Study Endpoints
Primary Endpoints
Safety and tolerance of different dose levels
12 weeks
Secondary Endpoints
Lack of immunogenicity
8 and 12 weeks
Pharmacodynamics
over 12 weeks
Pharmacokinetics
over 12 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose level 1EXPERIMENTAL120 mg/m2
Dose level 2EXPERIMENTAL200 mg/m2
Dose Level 3EXPERIMENTAL375 mg/m2
Dose level 1BEXPERIMENTAL80 mg/m2
Interventions
NameTypeDescription
hA20-humanized anti-CD20 antibodyDRUGonce weekly iv dosing for 4 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease

Countries:United States
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