A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors
Status: Completed
Location: See all (21) 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: f
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
Boston
Michigan
Henry Ford Hospital
Detroit
Pennsylvania
Upmc Cancercenter
Pittsburgh
Texas
Md Anderson Cancer Center
Houston
Washington
University of Washington
Seattle
Other Locations
Australia
Chris Obrien Lifehouse
Camperdown
Austin Hospital
Heidelberg
Nucleus Network Pty Ltd
Melbourne
Linear Clinical Research
Nedlands
Belgium
Cliniques Universitaires Ucl Saint-Luc
Brussels
Institut Jules Bordet Clinical Trials Conduct Unit
Brussels
Universitair Ziekenhuis Antwerpen (Uza)
Edegem
Ghent University Hospital
Ghent
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven
France
Institut de Cancerologie de L Ouest - Site Paul Papin
Angers
Institut Bergonie
Bordeaux
Chu Hopital de La Timone
Marseille
Centre Eugene Marquis
Rennes
Institut Gustave Roussy
Villejuif
Japan
National Cancer Center Hospital East
Chiba
National Cancer Center Hospital
Tokyo
Time Frame
Start Date:2020-09-04
Completion Date:2024-11-21
Participants
Target number of participants:182
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