Clinical Trial

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)

Recruiting Phase 1/2
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Summary
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)
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-13; most recent amendment 2026-06-26.
Trial Details
NCT Number NCT06975618
Lead Sponsor Haihe Biopharma Co., Ltd.
Conditions PIK3CA-Related Overgrowth Spectrum (PROS), PIK3CA-related Vascular Malformations (PRVM)
Enrollment 141 participants
Start Date 2023-08-22
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-29