Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer

Exclusion Criteria

• •1. Treatment with any of the following:
• •1. Previous or current treatment with PI3K, AKT or mTOR inhibitors.
• •2. Any cytotoxic chemotherapy, investigational agents within 21 days of the first dose of study drug; anticancer drugs which have been received within 14 days before the first administration.
• •3. Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
• •4. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
• •2. Inadequate bone marrow reserve or organ function.
• •3. Uncontrolled pleural effusion or ascites or pericardial effusion.
• •4. Known and untreated, or active central nervous system metastases.
• •5. History of primary or secondary diabetes.
• •6. History of acute or chronic pancreatitis
• •7. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow the study drug that would preclude adequate absorption of HS-10352.
• •8. History of hypersensitivity to any active or inactive ingredient of HS-10352 or to drugs with a similar chemical structure or class to HS-10352.
• •9. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
• •10. Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.