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INCB177054

Phase 1

Solid Tumors | Small molecule | Oncology |Incyte Corporation|Last Updated: Mar 25, 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 Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06873789A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 9Jun 30, 2025May 8, 2026Mar 25, 20269 United States
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Study Endpoints
Primary Endpoints
Number of participants with Dose Limiting Toxicities (DLTs)
Up to 28 days

Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

Number of participants with Treatment-emergent Adverse Events (TEAEs)
Up to approximately 12 months and 45 days

Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Number of participants with TEAEs leading to study drug modifications
Up to approximately 12 months and 45 days

Number of participants with TEAEs leading to dose modification including interruptions, dose reductions, and discontinuation of study drug.

Secondary Endpoints
Objective Response
Up to approximately 12 months
Duration of Response
Up to approximately 12 months
Disease Control
Up to approximately 12 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1a: Dose Escalation monotherapyEXPERIMENTALINCB177054 at the protocol-defined dose strength based on cohort assignment.
Part 1b: Pharmacodynamic cohortEXPERIMENTALINCB177054 at the protocol-defined dose strength based on cohort assignment.
Part 1c: Dose Expansion monotherapyEXPERIMENTALINCB177054 at the protocol-defined dose strength based on cohort assignment.
Part 2a: Dose Escalation combinationEXPERIMENTALINCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment.
Part 2b: Dose Expansion combinationEXPERIMENTALINCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment.
Interventions
NameTypeDescription
INCB177054DRUGINCB177054 will be administered at protocol defined dose.
RetifanlimabDRUGRetifanlimab will be administered at protocol defined dose.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Anticipated life expectancy greater than 12 weeks. * ECOG performance status score of 0 or 1. * Measurable disease per RECIST v1.1 on CT or MRI. * Part 1a and 2a (dose escalation) and Part 1c (dose expansion): participants who have a confirmed tissue diagnosis of a solid malig...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06873789primaryCompletionDate: changed
LOWMay 24, 2026NCT06873789studyFirstPostDate: changed