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 now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: PIK3CA-Related Overgrowth Spectrum (PROS), PIK3CA-related Vascular Malformations (PRVM)
In brief
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)
Key facts
- Study ID
- NCT06975618
- Run by
- Haihe Biopharma Co., Ltd.
- People needed
- 141
- Starts
- 2023-08-22
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-06-29
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Gifu University Hospital — Gifu, Japan (enrolling)
- Plastic Surgery Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
- Capital Center for Children's Health, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
- Shanghai Ninth People Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)
- Tonan Hospital — Sapporo, Hokkaido, Japan (enrolling)
- National Hospital Organization Kobe Medical Center — Kobe, Hyōgo, Japan (enrolling)
- Yokohama City University Hospital — Yokohama, Kanagawa, Japan (enrolling)
- Tohoku University Hospital — Sendai, Miyagi, Japan (enrolling)
- Shinshu University Hospital — Matsumoto, Nagano, Japan (enrolling)
- Kyorin University Hospital — Mitaka, Tokyo, Japan (enrolling)
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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