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Study identifier: NCT06975618 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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)

Condition: PIK3CA-Related Overgrowth Spectrum (PROS) · PIK3CA-related Vascular Malformations (PRVM)  ·  Sponsor: Haihe Biopharma Co., Ltd.

PhasePhase 1/Phase 2
Planned participants141
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

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)

This description comes directly from the study's public registry record.

Talk to the study team

Xiaoxi Lin, MD  ·  +86-13701997136  ·  linxiaoxi@126.com

Always discuss trial participation with your own doctor first.

Locations (15)

Capital Center for Children's Health, Capital Medical UniversityBeijing, Beijing Municipality, ChinaRecruiting
Plastic Surgery Hospital, Chinese Academy of Medical SciencesBeijing, Beijing Municipality, ChinaRecruiting
Fujian Medical University Union HospitalFuzhou, Fujian, ChinaRecruiting
Guangzhou Women and Children's Medical CenterGuangzhou, Guangdong, ChinaNot Yet Recruiting
Henan Provincial People's HospitalZhengzhou, Henan, ChinaRecruiting
The Second Xiangya Hospital of Central South UniversityChangsha, Hunan, ChinaRecruiting
Shanghai Ninth People Hospital, Shanghai Jiaotong University School of MedicineShanghai, Shanghai Municipality, ChinaRecruiting
West China Hospital of Sichuan UniversityChengdu, Sichuan, ChinaRecruiting
Tonan HospitalSapporo, Hokkaido, JapanRecruiting
National Hospital Organization Kobe Medical CenterKobe, Hyōgo, JapanRecruiting
Yokohama City University HospitalYokohama, Kanagawa, JapanRecruiting
Tohoku University HospitalSendai, Miyagi, JapanRecruiting

+ 3 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06975618