A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma

Criteria the registry did not label

• Main Inclusion Criteria:
• Female patients ≥ 18 years of age
• Provide informed consent voluntarily.
• Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma.
• Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status.
• Patients must have failed standard chemotherapy.
• ECOG-PS ≤ 1.
• Patient must have adequate organ and bone marrow function measured within 28 days of screening.
  • Main Exclusion Criteria:
  • Patients are ineligible for this study if they meet any of the following criteria:
• Patient has received any anticancer therapy
• Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor.
• Radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
• Any toxicities from prior treatment that have not recovered to baseline.
• Patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
• Patients who have symptomatic CNS metastasis.
• Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
• Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C.
• History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
• Patients with clinically significant cardiovascular disease