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INCB028060

Phase 1

Solid Tumor | Small molecule | Oncology |Incyte Corporation|Last Updated: Nov 22, 2017

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 Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01072266A Dose-escalation Study in Subjects With Advanced MalignanciesPHASE1 COMPLETED 45 — — Jan 1, 2010Jan 1, 2013Nov 22, 20172 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs
Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit.
Secondary Endpoints
c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation
Predose, specific hours post-dose on day and Day 15 of Cycle 1.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
INCB028060EXPERIMENTALSubjects will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group of patients may be enrolled and receive study drug. The initial cohort will be treated with 10 mg QD. The second cohort will be treated with 20 mg QD. The third cohort will be treated with 50 mg QD. Subsequent cohorts will be treated with two times the dose of the prior cohort to a limited toxicity level.
Interventions
NameTypeDescription
INCB028060DRUG10 mg and 50 mg capsules will be provided and dosed per the dosing schedule.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Subjects with neoplastic disease refractory to currently available therapies or for which no effective treatment is available * Subjects with life expectancy of 12 weeks or longer. * Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Excl...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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