A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.

Exclusion Criteria

• •1. Subject has acute promyelocytic leukemia.
• •2. Patients must not have had leukemia biotherapy 4 weeks prior to starting investigational drug, or less than 5 half-lives small molecular targeted drug therapy, or 28 days any anti-cancer therapy (whichever is longer)
• •3. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •4. Active infection requiring systemic antibiotic/antifungal medication, known clinically active hepatitis B or C, or HIV infection.
• •5. Participants who have received allogeneic HSCT, or autologous HSCT within 12 months.
• •6. Patients with active, uncontrolled CNS leukemia will not be eligible.
• •7. Any prior systemic MDM2-p53 inhibitor treatment
• •8. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
• •9. Subject has a history of other malignancies within 2 years prior to study entry, with the exception of:
• •* Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
• •* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
• •* Previous malignancy confined and surgically resected (or treated with other modalities) with curative intention: requires discussion with sponsor.