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INCB086550

Phase 2

Solid Tumors | Small molecule | Oncology |Incyte Corporation|Trials Updated: Aug 11, 2025

INCB086550 development status

Highest phase Phase 2 (NCT04629339)
Phase scored for INCYPhase 1
Registered trials 4 across 2 sponsors since Dec 2018

INCB086550 target and mechanism

Molecular targetCD274
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment138

FDA Designations

No designations recorded

INCB086550 clinical trials

INCB086550 · 1 trial · 1 indication

Phase 1 1
NCT03762447A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid TumorsSolid Tumors
COMPLETED138 Analytics
PHASE1COMPLETED
A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment-emergent adverse events
Baseline through 90 days after end of treatment, estimated up to 12 months.

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

Secondary Endpoints

Cmax of INCB086550 in fasted and food effect conditions
Approximately 1 month
tmax of INCB086550 in fasted and food effect conditions
Approximately 1 month
AUC0-tau of INCB086550 in fasted and food effect conditions
Approximately 1 month
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCB086550EXPERIMENTAL -

Interventions

NameTypeDescription
INCB086550DRUGINCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1 or RANO for primary brain tumors that are considered nonamenable to surgery or other curative treatments or procedures. Tumor lesions located in a previously irradiated area, or in an area s...

Countries:United StatesBelgiumFranceItalyUnited Kingdom
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

Frequently asked questions about INCB086550

What is INCB086550 used for?

INCB086550 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being developed by Incyte Corporation and has been evaluated in a Phase 1 clinical trial in adult patients with solid tumors. It is not approved for any indication.

What does INCB086550 target?

INCB086550 targets CD274, also known as PD-L1. It is an inhibitor of this target. By inhibiting CD274, INCB086550 is designed to interfere with a pathway that tumors use to evade immune detection, which is the rationale for its study in solid tumors.

Who makes INCB086550?

INCB086550 is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker INCY. Incyte is the sponsor of the clinical trial evaluating INCB086550 in patients with advanced solid tumors.

What phase is INCB086550 in?

INCB086550 is in Phase 1 clinical development. It has completed a Phase 1 trial in advanced solid tumors. The drug remains investigational and has not been approved by the FDA or any regulatory authority for commercial use.

What clinical trials is INCB086550 in?

INCB086550 has been studied in one clinical trial: NCT03762447, titled A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors. This Phase 1 trial is completed and enrolled 138 participants across the United States, Belgium, France, Italy, and the United Kingdom.