Study of INCB053914 in Subjects With Advanced Malignancies
Status:
Completed
Trial end date:
2020-07-22
Target enrollment:
Participant gender:
Summary
This is an open-label, dose-escalation study of the proviral integration site of Moloney
murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced
malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation)
will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and
the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken
forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will
further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of
the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of
INCB053914 in combination with select standard of care (SOC) agents and will identify the
optimal INCB053914 dose in combination with conventional SOC regimens to take forward into
Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and
pharmacokinetics of the recommended Phase 2 dose combination(s).