Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Inclusion Criteria: * Relapsed or refractory acute myeloid leukemia or IPSS-R intermediate/high/very high-risk MDS patients * Confirmed or anticipated wild-type TP53 * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * Adequate hepatic and renal function * Acceptable coagulation function * Negative serum or urine pregnancy test within 7 days prior to the first dose of ALRN-6924 for women of child-bearing potential * Sufficient wash out from prior therapies and recovery from all significant toxicities Exclusion Criteria: * Patients are eligible for available approved standard therapies * Prior treatment with MDM2 inhibitor, with protocol specified exceptions * Patients with history of allogeneic stem cell transplantation * Leukemic blast counts of \>25,000/µl * Deletion of chromosome 17, or del(17p) * Patients with evidence of current central nervous system leukemic involvement * Known hypersensitivity to any study drug component * History of coagulopathy * Prior specified cardiovascular risk factors * Clinically significant gastrointestinal bleeding within 6 months * Clinically significant third-space fluid accumulation * Pregnant or lactating females * Evidence of any serious and/or unstable pre-existing medical condition that would interfere with patient safety ability to provide informed consent * Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C * Second malignancy within one year, with protocol specified exceptions