Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
NCT ID: NCT04272034
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
105 participants
INTERVENTIONAL
2021-03-26
2024-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Participants with select solid tumors who are immunotherapy treatment-naive
INCB099318
INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
Cohort 2
Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
INCB099318
INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
Cohort 3
Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
INCB099318
INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
Interventions
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INCB099318
INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Louis Viviers, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Docrates Cancer Center
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
Sahlgrenska University Hospital
Gothenburg, , Sweden
Karolinska University Hospital Solna
Solna, , Sweden
Uppsala Universitet - Akademiska Sjukhuset
Uppsala, , Sweden
Western General Hospital
Edinburgh, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Guys and St Thomas Nhs Foundation Trust
London, , United Kingdom
The Royal Marsden Hospital Nhs Trust London
London, , United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, , United Kingdom
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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2019-004990-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 99318-122
Identifier Type: -
Identifier Source: org_study_id
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