Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
Checked against the public recordLast updated Oct 16, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Incyte Corporation
- Interventions being studied
- Drug: INCB099318
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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. * ECOG performance status score of 0 or 1. * Life expectancy \> 12 weeks. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: Exclusion Criteria: * Laboratory values outside the Protocol-defined ranges. * Clinically significant cardiac disease. * History or presence of an ECG 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 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.
U.S. locations
- Hackensack University Medical CenterHackensack, New Jersey
- Prisma Health Cancer Institute FarisGreenville, South Carolina
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee
- Universitair Ziekenhuis BrusselBrussels
- Institut Jules BordetBrussels
- Universitair Ziekenhuis Antwerpen (Uza)Edegem
- Ghent University HospitalGhent
- Universitaire Ziekenhuis Leuven - GasthuisbergLeuven
- Rigshospitalet Uni of Hospital of CopenhagenCopenhagen
- Helsinki University Central HospitalHelsinki
- Docrates Cancer CenterHelsinki
- Tampere University HospitalTampere
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 16, 2025. Always confirm current availability with the study team.