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TERMINATEDPHASE1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors

NCT04272034•Incyte Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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.
+3 more criteria

Locations (24)

Hackensack University Medical Center

Hackensack, New Jersey, United States

Prisma Health Cancer Institute Faris

Greenville, South Carolina, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Universitair Ziekenhuis Brussel

Brussels, Belgium

Institut Jules Bordet

Brussels, Belgium

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, Belgium

Ghent University Hospital

Ghent, Belgium

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, Belgium

Rigshospitalet Uni of Hospital of Copenhagen

Copenhagen, Denmark

Helsinki University Central Hospital

Helsinki, Finland

Key Dates

Start Date

March 26, 2021

Primary Completion Date

August 16, 2024

Completion Date

August 16, 2024

Last Updated

October 16, 2025

Enrollment

105

ACTUAL participants

Conditions

Advanced Solid TumorsMSI-H/dMMR TumorsCutaneous Squamous Cell CarcinomaUrothelial Carcinoma, HCCCervical CancerEsophageal Squamous Cell CarcinomaMerkel Cell CarcinomaSmall-cell Lung CancerMesotheliomaPD-L1 Amplified Tumor (9p24.1)Nasopharyngeal CarcinomaCyclin-dependent Kinase 12 Mutated TumorsBasal Cell Carcinoma (Unresectable or Metastatic)Sarcomatoid Renal Cell CarcinomaClear Cell Ovarian or Endometrial CarcinomaAnal CarcinomaSquamous Cell Penile CarcinomaDNA Polymerase Epsilon Mutated Tumors (P286R and V411L)

Interventions

INCB099318

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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