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INCB177054

Phase 1

Solid Tumors | Small molecule | Oncology |Incyte Corporation|Last Updated: Sep 2, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded
Trial Stopped -NCT06873789: This was a strategic business decision. There were no safety concerns contributing to this decision.

Clinical trial landscape

INCB177054 · 1 trial · 3 indications

Phase 1 1
NCT06873789A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid TumorsSolid Tumors
TERMINATED9 Analytics
PHASE1TERMINATED
A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors
Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Recent Changes (Last 90 Days)

CRITICALSep 2, 2026NCT06873789Status: ACTIVE_NOT_RECRUITING → TERMINATED
CRITICALSep 2, 2026NCT06873789Status: ACTIVE_NOT_RECRUITING → TERMINATED
CRITICALSep 2, 2026NCT06873789Status: ACTIVE_NOT_RECRUITING → TERMINATED
LOWJun 16, 2026NCT06873789primaryCompletionDate: changed
LOWJun 16, 2026NCT06873789primaryCompletionDate: changed
LOWJun 16, 2026NCT06873789primaryCompletionDate: changed

Frequently asked questions about INCB177054

What is INCB177054 used for?

INCB177054 is an investigational small molecule being studied for the treatment of select advanced or metastatic solid tumors. It is in Phase 1 clinical development for oncology indications, specifically targeting patients with advanced or metastatic solid tumors.

Who makes INCB177054?

INCB177054 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting clinical research on this investigational oncology drug candidate.

What phase is INCB177054 in?

INCB177054 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with advanced or metastatic solid tumors.

What clinical trials is INCB177054 in?

INCB177054 is being evaluated in a Phase 1 clinical trial with the identifier NCT06873789. This study, titled 'A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors,' was conducted in the United States and enrolled 9 participants aged 18 years and older.

Is INCB177054 the same as any other drug?

INCB177054 is the primary name for this investigational drug candidate developed by Incyte Corporation. No alternative names have been reported for this compound in the available clinical trial information.