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INCB040093

Phase 1

B-cell Malignancies | Small molecule | Other |Incyte Corporation|Last Updated: May 11, 2026

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 Enrollment121
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01905813Study of INCB040093 in Subjects With Previously Treated B-Cell MalignanciesPHASE1 COMPLETED 121 — — Jun 30, 2013Feb 26, 2026May 11, 20266 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of INCB040093 as monotherapy and when given in combination with itacitinib as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events
Measured every 3 weeks until progression.
Secondary Endpoints
Preliminary efficacy as assessed by Overall Response Rate (ORR) as measured by published criteria for Hodgkin's/non-Hodgkin's lymphoma (Cheson et al 2007 and Owen et al 2013) and Chronic Lymphocytic Leukemia (CLL) (Cheson et el 2012)
Every 12 weeks (4 cycles) until study withdrawal
Pharmacokinetic (PK) collections.
Measured for each patient at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 1 Day 15
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
INCB040093EXPERIMENTAL -
INCB040093 in combination with itacitinib (INCB039110)EXPERIMENTAL -
Interventions
NameTypeDescription
INCB040093DRUGEscalating doses starting at 100 mg every day (QD)
INCB040093 + itacitinibDRUGINCB040093 dose to be determined at completion of Part 1 of the study + itacitinib at a starting dose of 400 mg, QD with escalations planned up to 600 mg QD.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: • Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows: \*Indolent / aggressive B-cell (NHL) Non- Hodgkin's Lymphoma: EXCLUDING: Burkitt lymphoma and precursor B-lymphoblastic leukemia/lymphoma INCLUDING: any non-Hodgkin's B-cell malignancy such as C...

Countries:United States
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT01905813Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT01905813studyFirstPostDate: changed