Actively 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)
Led by Haihe Biopharma Co., Ltd. · Updated on 2025-09-24
141
Participants Needed
4
Research Sites
331 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legal guardian voluntarily signs informed consent.
- Adult patients are 18 years or older; adolescent patients are 12 to under 18 years old and weigh at least 35 kg.
- Diagnosis of PIK3CA-related overgrowth spectrum (PROS) or PIK3CA-related vascular malformations (PRVM) with confirmed PIK3CA mutation and at least one measurable lesion.
- Adequate organ and bone marrow function during the 28-day screening period.
You will not qualify if you...
- PROS patients with only isolated macrodactyly, epidermal nevi/nevus, or megalencephaly without other PROS lesions.
- Received any systemic treatment for PROS or PRVM within 8 weeks before the first study drug dose, or any drug treatment like mTOR inhibitors within 28 days before the first dose.
- Previously received any PI3K inhibitor treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Capital Institute of Pediatrics
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100144
Actively Recruiting
3
Shanghai Ninth People Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
4
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xiaoxi Lin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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