This is a Phase I, open-label, dose-finding study of the triple kinase inhibitor LNK01002 in patients with myelofibrosis (MF). The study consists of two periods: the dose escalation, main period and a dose expansion period. In the dose escalation period, successive cohorts of patients with MF will be enrolled to establish the maximum tolerated dose. In the dose expansion period (dose-confirmation phase), three cohorts of patients will be enrolled: AML patients with confirmed FLT3-ITD mutations, AML patients without FLT3-ITD mutations, and patients with primary MF or PV/ET-MF.~The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of LNK01002 in patients with myelofibrosis/AML will be evaluated.
This multicenter, open-label, phase 1 study designed to evaluate safety and tolerability of multi-kinase inhibitor LNK01002 in patients with primary myelofibrosis (MF), or MF due to polycythemia vera (PV-MF), or essential thrombocythemia (ET-MF), or with acute myeloid leukemia (AML).