A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Inclusion Criteria

• Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
• Previously untreated AML and eligible to receive intensive chemotherapy.
• KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613.
• Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if >65 years old .
• Adequate liver, kidney, and cardiac function.

Exclusion Criteria

• Diagnosis of acute promyelocytic leukemia.
• Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms).
• Fridericia's corrected QT interval (QTcF) >450 milliseconds (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
• Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion.
• Cirrhosis with a Child-Pugh score of B or C.
• Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
• Hepatitis B, Hepatitis C, or HIV-positive with detectable viral load.
• Documented active, uncontrolled infection.
• Uncontrolled disseminated intravascular coagulation.
• Lactating/breast feeding or pregnant.
• Use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy.
• Use of strong CYP3A4 inducers or inhibitors (except for Itraconazole, Ketoconazole, Posaconazole, or Voriconazole).