Overview

This study is a multi-center, open-label, single arm, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 in patients with PIK3CA-related overgrowth spectrum (PROS) and PIK3CA-related vascular malformations (PRVM)

Eligibility

Inclusion Criteria:

• The patient or the patient's guardian (if applicable) voluntarily signs the Informed Consent Form.
• At the time of signing the Informed Consent, the age of adult patients should be ≥ 18 years, and the age of adolescent patients should be ≥ 12 years and < 18 years of age.
• Patient diagnosed with PIK3CA-related overgrowth spectrum (PROS) or PIK3CA-related vascular malformation (PRVM).
• Patients should be tested to have adequate organ and bone marrow function, within 28 days of the screening period.

Exclusion Criteria:

• Patients who have received any prior treatment with PI3K or AKT inhibitors.
• Received a blood transfusion or platelet transfusion within 2 weeks prior to the administration of the investigational drug.
• Patients with clinically significant cardiovascular disease.