A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Massachusetts
Dana Farber Cancer Institute
Completed
Boston
Michigan
Henry Ford Hospital
Recruiting
Detroit
Pennsylvania
Upmc Cancercenter
Completed
Pittsburgh
Texas
Md Anderson Cancer Center
Recruiting
Houston
Washington
University of Washington
Recruiting
Seattle
Other Locations
Australia
Chris Obrien Lifehouse
Recruiting
Camperdown
Austin Hospital
Completed
Heidelberg
Nucleus Network Pty Ltd
Completed
Melbourne
Linear Clinical Research
Recruiting
Nedlands
Belgium
Cliniques Universitaires Ucl Saint-Luc
Recruiting
Brussels
Institut Jules Bordet Clinical Trials Conduct Unit
Recruiting
Brussels
Universitair Ziekenhuis Antwerpen (Uza)
Recruiting
Edegem
Ghent University Hospital
Recruiting
Ghent
Universitaire Ziekenhuis Leuven - Gasthuisberg
Recruiting
Leuven
Bulgaria
Complex Onclogy Center Plovdiv Eood
Not yet recruiting
Plovdiv
Complex Oncological Center - Ruse Eood
Not yet recruiting
Ruse
Shatod Dr Marko Marko - Varna Ltd
Not yet recruiting
Varna
France
Institut de Cancerologie de L Ouest - Site Paul Papin
Recruiting
Angers
Institut Bergonie
Recruiting
Bordeaux
Chu Hopital de La Timone
Recruiting
Marseille Cedex 5
Centre Eugene Marquis
Recruiting
Rennes
Japan
National Cancer Center Hospital East
Not yet recruiting
Chiba
National Cancer Center Hospital
Not yet recruiting
Tokyo
Ukraine
Multifield Clinical Hospital No 4
Not yet recruiting
Dnipro
Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection
Not yet recruiting
Kharkiv
Kherson Regional Oncologic Dispensary
Not yet recruiting
Kherson
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Not yet recruiting
Kryvyi Rih
Volyn Regional Oncological Dispensary
Not yet recruiting
Lutsk
Rmi Sumy Regional Clinical Oncology Dispensary
Not yet recruiting
Sumy
Cne Ccch of Uzh Cc Oncological Center
Not yet recruiting
Uzhgorod
Medical Clinic Innovacia Llc
Not yet recruiting
Vyshhorod
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
globalmedinfo@incyte.com
+800 00027423
Time Frame
Start Date: September 4, 2020
Estimated Completion Date: March 29, 2026
Participants
Target number of participants: 203
Treatments
Experimental: Cohort 1
Participants with select solid tumors who are immunotherapy treatment-naive
Experimental: Cohort 2
Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
Experimental: Cohort 3
Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
Sponsors
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov

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