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LEQ506

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Dec 17, 2020

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 Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01106508A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid TumorsPHASE1 COMPLETED 57Oct 1, 2010Jun 1, 2015Dec 17, 20205 United States, Netherlands +2
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Study Endpoints
Primary Endpoints
To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
21 day cycles
Secondary Endpoints
To characterize the safety and tolerability of LEQ506 treatment
21 day cycles
To characterize the pharmacokinetics of LEQ506
21 day cycles
To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples
21 day cycles
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LEQ506EXPERIMENTAL -
Interventions
NameTypeDescription
LEQ506DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma) * Protocol defined laboratory parameters * Performance status ≤ 2 * Patients must have fully recovered from the prior effects of major s...

Countries:United StatesNetherlandsSwitzerlandUnited Kingdom
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