Esophageal Cancer Clinical Trial
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.
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.
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-immunotherapy-drugs-are-boosting-survival/" >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.
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There are 24 Locations for this study
Hackensack New Jersey, 07601, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37232, United States
Brussels , 01090, Belgium
Brussels , B-107, Belgium
Edegem , 02650, Belgium
Ghent , 09000, Belgium
Leuven , 03000, Belgium
Copenhagen , 02100, Denmark
Helsinki , 00029, Finland
Helsinki , 00180, Finland
Tampere , 33520, Finland
Turku , 20520, Finland
Bergen , 05051, Norway
Oslo , 00450, Norway
Goteborg , 41345, Sweden
Solna , 17164, Sweden
Uppsala , 75185, Sweden
Edinburgh , EH4 2, United Kingdom
Leeds , LS9 7, United Kingdom
London , SE1 9, United Kingdom
London , SM2 5, United Kingdom
London , W12 0, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
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