Phase 1 study of Venetoclax/Azacitidine or Venetoclax in combination with Ziftomenib (KO-539) or standard induction Cytarabine/Daunorubicin (7+3) chemotherapy in combination with Ziftomenib for the treatment of patients with Acute Myeloid Leukemia

Objective:

Primary Objectives:

• To determine the safety and tolerability of
  ziftomenib combined with SOC treatments in adults
  with newly diagnosed NPM1-m or KMT2A-r AML
  and for ziftomenib combined with SOC treatments
  in NPM1-m or KMT2A-r patients with relapsed or
  refractory AML
• To determine the antileukemic activity of
  ziftomenib combined with SOC treatments in adults
  with newly diagnosed NPM1-m or KMT2A-r AML
  and for ziftomenib combined with SOC treatments
  in NPM1-m or KMT2A-r patients with relapsed or
  refractory AML

Secondary Objectives:

• To evaluate survival, disease control outcomes and
  additional markers of antileukemic activity for
  ziftomenib combined with SOC treatments in adults
  with newly diagnosed NPM1-m or KMT2A-r AML
  and for ziftomenib combined with SOC treatments
  in NPM1-m or KMT2A-r patients with relapsed or
  refractory AML
• Characterize the pharmacokinetics of ziftomenib
  and metabolites when administered in combination
  with SOC treatments in adults with newly
  diagnosed NPM1-m or KMT2A-r AML and for
  ziftomenib combined with SOC treatments in
  NPM1-m or KMT2A-r patients with relapsed or
  refractory AML
• To evaluate the potential drug interaction of
  ziftomenib on venetoclax (i.e., potential inhibition
  of CYP3A4 metabolism of venetoclax by
  ziftomenib)