A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)

Primary Objectives: Phase Ib • To determine the safety, tolerability and recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML). Phase II • To assess the efficacy of SNDX-5613 in combination with ASTX727 and venetoclax for patients with AML. Secondary Objectives • To assess overall survival, event-free survival and duration of response. Exploratory Objectives • To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance.