Esophageal Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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-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 Human Immunodeficiency Virus (HIV)
Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

203

Study ID:

NCT04242199

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 28 Locations for this study

See Locations Near You

Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Upmc Cancercenter
Pittsburgh Pennsylvania, 15232, United States
Md Anderson Cancer Center
Houston Texas, 77030, United States
University of Washington
Seattle Washington, 98195, United States
Chris Obrien Lifehouse
Camperdown New South Wales, 02050, Australia
Austin Hospital
Heidelberg Victoria, 03084, Australia
Nucleus Network Pty Ltd
Melbourne Victoria, 03004, Australia
Linear Clinical Research
Nedlands Western Australia, 06009, Australia
Cliniques Universitaires Ucl Saint-Luc
Brussels , 01200, Belgium
Institut Jules Bordet Clinical Trials Conduct Unit
Brussels , B-107, Belgium
Universitair Ziekenhuis Antwerpen (Uza)
Edegem , 02650, Belgium
Ghent University Hospital
Ghent , 09000, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven , 03000, Belgium
Complex Onclogy Center Plovdiv Eood
Plovdiv , 04004, Bulgaria
Complex Oncological Center - Ruse Eood
Ruse , 07002, Bulgaria
Shatod Dr Marko Marko - Varna Ltd
Varna , , Bulgaria
Institut de Cancerologie de L Ouest - Site Paul Papin
Angers , 49000, France
Institut Bergonie
Bordeaux , 33000, France
Chu Hopital de La Timone
Marseille Cedex 5 , 13385, France
Centre Eugene Marquis
Rennes , 35042, France
Multifield Clinical Hospital No 4
Dnipro , 49102, Ukraine
Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection
Kharkiv , 61166, Ukraine
Kherson Regional Oncologic Dispensary
Kherson , 73000, Ukraine
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih , 50048, Ukraine
Volyn Regional Oncological Dispensary
Lutsk , 43018, Ukraine
Rmi Sumy Regional Clinical Oncology Dispensary
Sumy , 40022, Ukraine
Cne Ccch of Uzh Cc Oncological Center
Uzhgorod , 88000, Ukraine
Medical Clinic Innovacia Llc
Vyshhorod , 07352, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

203

Study ID:

NCT04242199

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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