A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic Malignancies

Exclusion Criteria

• •1. Prior history of allogeneic cell transplant.
• •2. Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia.
• •3. Received chemotherapy within 14 days prior to entering the study.
• •4. Received biologic (\< 28 days), small molecule targeted therapies (\< 5 half-life) or other anti-cancer therapy within 21 days of study entry.
• •5. Concurrent treatment with an investigational agent, 14 days for small molecular agents and/or 28 days for biologics treatment prior to the first dose of therapy.
• •6. Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry.
• •7. Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator.
• •8. Has known active central nervous system (CNS) involvement.
• •9. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy.
• •10. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
• •11. Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.
• •12. Active rheumatoid arthritis (RA), active inflammatory bowel disease, or any other disease or condition associated with chronic inflammation.
• •13. Active infection requiring systemic antibiotic/ antifungal medication, known clinically active hepatitis B or C infection, or known HIV disease.
• •14. Known or suspected Wilson's Disease, or other conditions that affect copper accumulation or regulation.
• •15. Uncontrolled concurrent illness including, but not limited to: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
• •16. The last treatment for the subject before signing the informed consent was bcl-2 targeted drug treatment (if the subject had received bcl-2 inhibitor treatment but did not develop drug resistance, it could be included in this study).
• •17. History of secondary active malignancies within the past 2 years. However, adequately treated superficial skin cancer other than melanoma, in-situ cervix cancer more than 4 weeks, or prostate cancer not requiring any treatment and under surveillance prior to enrollment will not be considered exclusionary.
• •18. Known to be allergic to study drug ingredients or their analogues.
• •19. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of APG-2575.
• •20. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.