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 firstdose 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 cerebrospinalfluid, 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 affectoral 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: myocardialinfarction, uncontrolled/unstable angina, congestive heart failure (New York HeartAssociation 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).