This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 and spliceosome mutated Relapsed or Refractory Acute Myeloid Leukemia
Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
Patient is ≥18 years of age at the time of obtaining informed consent.
Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).
Group 1: Patient must have a confirmed FLT3-ITD or FLT3-TKD mutation by central laboratory testing. Group 2: Patient must have a documented SF3B1, SRSF2, U2AF1, or ZRSR2 pathogenic mutation by local lab sequencing.
Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
Patient is ≥18 years of age at the time of obtaining informed consent.
Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).
Patient must have a confirmed FLT3 ITD, TKD or ITD-F691L mutation documented within the past 90 days in absence of therapy or within the Screening period 28 days) prior to study drug administration on C1D1 if therapy has been given.
Sequential
ZE46-0134
Drugoral capsules QD
18
Treatment groupsSee each treatment group below.
The incidence of DLTs
To determine the maximum tolerated dose or biologically effective dose of ZE46-0134 in adults with FLT3 and spliceosome mutated relapsed and refractory AML.
Incidence of AE/SAE
Incidence of clinically significant abnormal laboratory results
Incidence of abnormal clinically significant ECG results
Number of patients with AEs of Grade ≥ 3
Proportion of patients who became FLT3 ITD and TKD undetectable
Number of patients with Genomic or proteomic abnormalities
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