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hLL1

Phase 1

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: May 29, 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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00504972Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell MalignanciesPHASE1 COMPLETED 23Jun 1, 2007Oct 7, 2015May 29, 20181 United States
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Study Endpoints
Primary Endpoints
To determine the toxicity profile and maximum tolerated dose (MTD) of hLL1 when administered to patients with recurrent non-Hodgkin's lymphoma and chronic lymphocytic leukemia
duration of study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Study TreatmentEXPERIMENTALThis study is a single arm study
Interventions
NameTypeDescription
hLL1DRUGhLL1 administered intravenously once daily Monday through Friday for 2 consecutive weeks (10 total doses) at one of 4 planned dose levels: 1.5, 4, 6 or 8 mg/kg.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically confirmed diagnosis of recurrent B cell non-Hodgkin's lymphoma or diagnosis of recurrent chronic lymphocytic leukemia * Patient has received at least one prior treatment with standard chemotherapy and at least one prior treatment with rituximab (negative HAHA te...

Countries:United States
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