Esophageal Cancer Clinical Trial

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

Summary

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT04272034

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 24 Locations for this study

See Locations Near You

Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Prisma Health Cancer Institute Faris
Greenville South Carolina, 29605, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Universitair Ziekenhuis Brussel
Brussels , 01090, Belgium
Institut Jules Bordet
Brussels , B-107, Belgium
Universitair Ziekenhuis Antwerpen (Uza)
Edegem , 02650, Belgium
Ghent University Hospital
Ghent , 09000, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven , 03000, Belgium
Rigshospitalet Uni of Hospital of Copenhagen
Kobenhavn , 2100, Denmark
Helsinki University Central Hospital
Helsinki , 00029, Finland
Docrates Cancer Center
Helsinki , 00180, Finland
Tampere University Hospital
Tampere , 33520, Finland
Turku University Hospital
Turku , 20520, Finland
Haukeland University Hospital
Bergen , 05051, Norway
Oslo Universitetssykehus
Oslo , 00450, Norway
Sahlgrenska University Hospital
Goteborg , 41345, Sweden
Karolinska University Hospital Solna
Solna , 17164, Sweden
Uppsala Universitet - Akademiska Sjukhuset
Uppsala , 75185, Sweden
Western General Hospital
Edinburgh , EH4 2, United Kingdom
St James University Hospital
Leeds , LS9 7, United Kingdom
Guys and St Thomas Nhs Foundation Trust
London , SE1 9, United Kingdom
The Royal Marsden Hospital Nhs Trust London
London , SM2 5, United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London , W12 0, United Kingdom
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Newcastle Upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT04272034

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.