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veltuzumab

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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00546793Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLLPHASE1 COMPLETED 32Jan 1, 2008Mar 1, 2013Aug 16, 20215 United States
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Study Endpoints
Primary Endpoints
Safety/tolerability
over 2 years after treatment

safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
veltuzumabEXPERIMENTALveltuzumab is a humanized CD20 antibody administered subcutaneously in this study.
Interventions
NameTypeDescription
veltuzumabBIOLOGICALveltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL) * Either previously untreated or relapsed * Measurable disease (at least one lesion \> 1.5 cm for NHL, or ALC \> 5,000 for CLL) see full protocol for additional criteria Exclusion Criteria:...

Countries:United States
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