Status:
TERMINATED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
Lead Sponsor:
Incyte Corporation
Conditions:
Advanced Solid Tumors
MSI-H/dMMR Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2024
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04272034
Start Date
March 26 2021
End Date
August 16 2024
Last Update
October 16 2025
Active Locations (24)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
2
Prisma Health Cancer Institute Faris
Greenville, South Carolina, United States, 29605
3
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
4
Universitair Ziekenhuis Brussel
Brussels, Belgium, 01090