RecruitingPhase 1Phase 2NCT06975618

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)

A Phase I/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CYH33 (a Selective PI3Kα Inhibitor) in Patients With PIK3CA-related Overgrowth Spectrum (PROS) and PIK3CA-related Vascular Malformations (PRVM)

Sponsor

Haihe Biopharma Co., Ltd.

Enrollment

141 participants

Start Date

Aug 22, 2023

Study Type

INTERVENTIONAL

Conditions

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)

Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CYH33 and a drug called Placebo for people with pik3ca-related overgrowth spectrum (pros) and pik3ca-related vascular malformations (prvm). The study is currently recruiting participants at 15 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCYH33

CYH33: Participants will receive oral CYH33 once daily. The starting dose for adults in Phase I is 10 mg QD; adolescents begin at 5 mg QD. In Phase II, patients will receive RP2D determined in the Phase I study.

DRUGPlacebo

Placebo: Matching placebo tablets will be administered once daily during the double-blind period of the Phase II PRVM cohort. Patients randomized to placebo will switch to CYH33 at the end of the blinded phase.

Locations(15)

Capital Center for Children's Health, Capital Medical University

Beijing, Beijing Municipality, China

Plastic Surgery Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Shanghai Ninth People Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tonan Hospital

Sapporo, Hokkaido, Japan

National Hospital Organization Kobe Medical Center

Kobe, Hyōgo, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Shinshu University Hospital

Matsumoto, Nagano, Japan

Kyorin University Hospital

Mitaka, Tokyo, Japan

Gifu University Hospital

Gifu, Japan

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NCT06975618

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