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Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Sponsor: Incyte Corporation
Summary
The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.
Official title: A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
121
Start Date
2013-06-30
Completion Date
2026-04-17
Last Updated
2025-12-19
Healthy Volunteers
No
Conditions
Interventions
INCB040093
Escalating doses starting at 100 mg every day (QD)
INCB040093 + itacitinib
INCB040093 dose to be determined at completion of Part 1 of the study + itacitinib at a starting dose of 400 mg, QD with escalations planned up to 600 mg QD.
Locations (6)
Birmingham, Alabama, United States
Jacksonville, Florida, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
New York, New York, United States
Rochester, New York, United States