Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
Status:
Terminated
Trial end date:
2019-02-13
Target enrollment:
Participant gender:
Summary
The purpose of the Study is to select a dose and assess the safety and tolerability of
INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care
(SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies.
Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that
demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety,
preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types
including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine
the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety
and tolerability of the combination therapy in select advanced solid tumors and hematologic
malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of
the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic
malignancies.