CompletedPhase 1NCT04242199

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors

Checked against the public recordLast updated Jul 14, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations21
SponsorIncyte Corporation
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Incyte Corporation
Interventions being studied
Drug: INCB099280
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Biomarkers
03
Public criteria

Who may be able to participate

Inclusion Criteria: * Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment. * Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures. * Eastern Cooperative Oncology Group performance status score of 0 or 1. * Life expectancy \> 12 weeks. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Laboratory values outside the Protocol-defined ranges. * Clinically significant cardiac disease. * History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful. * Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases). * Known additional malignancy that is progressing or requires active treatment. * Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment. * Prior receipt of an anti-PD-L1 therapy. * Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * A 28-day washout for systemic antibiotics is required. * Probiotic usage while on study and during screening is prohibited. * Active infection requiring systemic therapy. * Known history of Human Immunodeficiency Virus (HIV) * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Henry Ford HospitalDetroit, Michigan
  • Upmc CancercenterPittsburgh, Pennsylvania
  • Md Anderson Cancer CenterHouston, Texas
  • University of WashingtonSeattle, Washington
  • Chris Obrien LifehouseCamperdown, New South Wales
  • Austin HospitalHeidelberg, Victoria
  • Nucleus Network Pty LtdMelbourne, Victoria
  • Linear Clinical ResearchNedlands, Western Australia
  • Cliniques Universitaires Ucl Saint-LucBrussels
  • Institut Jules Bordet Clinical Trials Conduct UnitBrussels
  • Universitair Ziekenhuis Antwerpen (Uza)Edegem

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2025. Always confirm current availability with the study team.

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