An Open-label, Dose-Escalation and Dose-Expansion Study of GB3226 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
brief summary
Study GB3226-DEV-001 is a Phase 1/2, open-label, dose-escalation and expansion study of GB3226 in the treatment of relapsed or refractory acute myeloid leukaemia
detailed description
Study GB3226-DEV-001 is a Phase 1/2, open-label, dose-escalation and expansion study of GB3226 in the treatment of relapsed or refractory acute myeloid leukemia. Adult patients aged ≥18 years of age are planned to be enrolled. GB3226 will be administered once daily orally (PO) in 28-day cycles, with the first study drug dose administered on Cycle 1 Day 1 (C1D1). Up to a total of three separate patient cohorts will be explored (GB3226 without a CYP3A4 inhibitor, GB3226 with a strong CYP3A4 inhibitor and, if indicated, a cohort of GB3226 with a moderate CYP3A4 inhibitor).
official title
A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of GB3226 in Patients With Relapsed/Refractory Acute Myeloid Leukemia