Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

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.

Timeline

Start

2013-06-30

Primary completion

2026-02-26

Completion

2026-02-26

Publications

• Phillips TJ, Forero-Torres A, Sher T, Diefenbach CS, Johnston P, Talpaz M, Pulini J, Zhou L, Scherle P, Chen X, Barr PM. Phase 1 study of the PI3Kdelta inhibitor INCB040093 +/- JAK1 inhibitor itacitinib in relapsed/refractory B-cell lymphoma. Blood. 2018 Jul 19;132(3):293-306. doi: 10.1182/blood-2017-10-812701. Epub 2018 Apr 25.

Drugs

Indications