[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591068":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":283,"collaborators":33,"id":285,"slug":286,"hasResults":287,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":33,"eligibilityCriteria":291,"healthyVolunteers":287,"sex":292,"minAge":33,"maxAge":33,"enrollmentInfo":293,"targetDuration":33,"studyType":296,"phases":297,"briefSummary":300,"conditions":301,"keywords":33,"overallStatus":47,"whyStopped":33,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},{"fullName":5,"class":6},"Haihe Biopharma Co., Ltd.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1：Adult cohort:；","EXPERIMENTAL","Phase I Adult Cohort: Adult patients with PIK3CA-related overgrowth spectrum (PROS) or PIK3CA-related vascular malformations (PRVM) will receive escalating oral doses of CYH33 to determine the maximum tolerated dose (MTD) and\u002For recommended Phase II dose (RP2D). Expansion cohorts may be opened to further assess safety, tolerability, pharmacokinetics, and preliminary efficacy.",[13],"Drug: CYH33",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Phase I Adolescent Cohort","Phase I Adolescent Cohort: Adolescent patients with PIK3CA-related overgrowth spectrum (PROS) or PIK3CA-related vascular malformations (PRVM) will receive escalating oral doses of CYH33 to determine the maximum tolerated dose (MTD) and\u002For recommended Phase II dose (RP2D). Expansion cohorts may be opened to further assess safety, tolerability, pharmacokinetics, and preliminary efficacy.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Arm 3 : Phase II PROS Cohort","Phase II PROS Cohort: An open-label, single-arm cohort. Adult and adolescent patients with PROS will receive CYH33 at RP2D. Dose escalation may be allowed based on tolerability and clinical assessment. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Arm 4 : Phase II PRVM Cohort","Phase II PRVM Cohort: Adult and adolescent patients with PRVM will be randomized 2:1 to CYH33 or placebo during double-blind period. After 8 weeks of treatment, all patients will enter an open-label extension phase to receive CYH33. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.",[13,26],"Drug: Placebo",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","CYH33","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.",[9,15,19,23],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Placebo","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.",[23],[39],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"Xiaoxi Lin, MD","CONTACT","+86-13701997136","linxiaoxi@126.com",[45,66,78,94,111,125,142,155,170,188,204,220,237,251,267],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Capital Center for Children's Health, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100000","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60,64],{"name":61,"role":41,"phone":62,"phoneExt":33,"email":63},"Ying Gao, MD","+86-15210250269","sccgcw@sina.com",{"name":61,"role":65,"phone":33,"phoneExt":33,"email":33},"PRINCIPAL_INVESTIGATOR",{"facility":67,"status":47,"city":48,"state":49,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Plastic Surgery Hospital, Chinese Academy of Medical Sciences","100144",{"type":54,"coordinates":70},[56,57],{"lat":57,"lon":56},[73,77],{"name":74,"role":41,"phone":75,"phoneExt":33,"email":76},"Yan Yan, MD","+86-13661348184","yanyan201606@163.com",{"name":74,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":79,"status":47,"city":80,"state":81,"zip":82,"country":51,"countryCode":52,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Fujian Medical University Union Hospital","Fuzhou","Fujian","350001",{"type":54,"coordinates":84},[85,86],119.30611,26.06139,{"lat":86,"lon":85},[89,93],{"name":90,"role":41,"phone":91,"phoneExt":33,"email":92},"Xiaosong Chen","+86-13365910035","chenxiaosong74@163.com",{"name":90,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":51,"countryCode":52,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Guangzhou Women and Children's Medical Center","NOT_YET_RECRUITING","Guangzhou","Guangdong","510000",{"type":54,"coordinates":101},[102,103],113.25,23.11667,{"lat":103,"lon":102},[106,110],{"name":107,"role":41,"phone":108,"phoneExt":33,"email":109},"Haibo Li, MD","+86-13711745928","448214152@qq.com",{"name":107,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":112,"status":47,"city":113,"state":114,"zip":115,"country":51,"countryCode":52,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Henan Provincial People's Hospital","Zhengzhou","Henan","450003",{"type":54,"coordinates":117},[118,119],113.64861,34.75778,{"lat":119,"lon":118},[122,124],{"name":123,"role":41,"phone":33,"phoneExt":33,"email":33},"Jianbo Wang, MD",{"name":123,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":126,"status":47,"city":127,"state":128,"zip":129,"country":51,"countryCode":52,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"The Second Xiangya Hospital of Central South University","Changsha","Hunan","410011",{"type":54,"coordinates":131},[132,133],112.97087,28.19874,{"lat":133,"lon":132},[136,138,141],{"name":137,"role":41,"phone":33,"phoneExt":33,"email":33},"Chang Shu",{"name":33,"role":41,"phone":139,"phoneExt":33,"email":140},"+86-13607444222","changshu01@yahoo.com",{"name":137,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":143,"status":47,"city":144,"state":145,"zip":146,"country":51,"countryCode":52,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Shanghai Ninth People Hospital, Shanghai Jiaotong University School of Medicine","Shanghai","Shanghai Municipality","200011",{"type":54,"coordinates":148},[149,150],121.45806,31.22222,{"lat":150,"lon":149},[153,154],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},{"name":40,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":156,"status":47,"city":157,"state":158,"zip":159,"country":51,"countryCode":52,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"West China Hospital of Sichuan University","Chengdu","Sichuan","610041",{"type":54,"coordinates":161},[162,163],104.06667,30.66667,{"lat":163,"lon":162},[166],{"name":167,"role":41,"phone":168,"phoneExt":33,"email":169},"Xian Jiang, MD","+86-18980601693","jx0133@qq.com",{"facility":171,"status":47,"city":172,"state":173,"zip":174,"country":175,"countryCode":176,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Tonan Hospital","Sapporo","Hokkaido","060-0004","Japan","JP",{"type":54,"coordinates":178},[179,180],141.35,43.06667,{"lat":180,"lon":179},[183,187],{"name":184,"role":41,"phone":185,"phoneExt":33,"email":186},"Sasaki Satoru","+81-11-231-2121","satokyan99@yahoo.co.jp",{"name":184,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":189,"status":47,"city":190,"state":191,"zip":192,"country":175,"countryCode":176,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"National Hospital Organization Kobe Medical Center","Kobe","Hyōgo","654-0155",{"type":54,"coordinates":194},[195,196],135.183,34.6913,{"lat":196,"lon":195},[199,203],{"name":200,"role":41,"phone":201,"phoneExt":33,"email":202},"Nomura Tadashi, Director of department","+81-78-791-0111","tadnomura@gmail.com",{"name":200,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":205,"status":47,"city":206,"state":207,"zip":208,"country":175,"countryCode":176,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Yokohama City University Hospital","Yokohama","Kanagawa","236-0004",{"type":54,"coordinates":210},[211,212],139.65,35.43333,{"lat":212,"lon":211},[215,219],{"name":216,"role":41,"phone":217,"phoneExt":33,"email":218},"Hayashi Ayato, Professor","81-45-787-2800","hayashi.aya.jb@yokohama-cu.ac.jp",{"name":216,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":221,"status":47,"city":222,"state":223,"zip":224,"country":175,"countryCode":176,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Tohoku University Hospital","Sendai","Miyagi","980-8574",{"type":54,"coordinates":226},[227,228],140.86667,38.26667,{"lat":228,"lon":227},[231,235],{"name":232,"role":41,"phone":233,"phoneExt":33,"email":234},"Imai Yoshimichi Professor","+81-22-717-7000","yoshimichi.imai.d6@tohoku.ac.jp",{"name":236,"role":65,"phone":33,"phoneExt":33,"email":33},"Imai Yoshimichi, Professor",{"facility":238,"status":47,"city":239,"state":240,"zip":241,"country":175,"countryCode":176,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Shinshu University Hospital","Matsumoto","Nagano","390-8621",{"type":54,"coordinates":243},[244,245],137.96667,36.23333,{"lat":245,"lon":244},[248,250],{"name":249,"role":41,"phone":33,"phoneExt":33,"email":33},"Yuzuriha Shunsuke",{"name":249,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":252,"status":47,"city":253,"state":254,"zip":255,"country":175,"countryCode":176,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Kyorin University Hospital","Mitaka","Tokyo","181-8611",{"type":54,"coordinates":257},[258,259],139.56002,35.68361,{"lat":259,"lon":258},[262,266],{"name":263,"role":41,"phone":264,"phoneExt":33,"email":265},"Ozaki Mine, Professor","+81-422-47-5511","zakimin0108@gmail.com",{"name":263,"role":65,"phone":33,"phoneExt":33,"email":33},{"facility":268,"status":47,"city":269,"state":33,"zip":270,"country":175,"countryCode":176,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Gifu University Hospital","Gifu","501-1194",{"type":54,"coordinates":272},[273,274],136.76039,35.42291,{"lat":274,"lon":273},[277,281],{"name":278,"role":41,"phone":279,"phoneExt":33,"email":280},"Ozeki Michio Associate Professor","+81-58-230-6000","ozeki.michio.j5@f.gifu-u.ac.jp",{"name":282,"role":65,"phone":33,"phoneExt":33,"email":33},"Ozeki Michio, Associate Professor",{"type":284,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100591068","phase-1-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-100591068",false,"NCT06975618","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\u002FII, 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)","Key inclusion criteria:\n\n1. The patient or the patient's legal guardian (if applicable) voluntarily signs the Informed Consent Form.\n2. At the time of signing the informed consent, adult patients should be ≥18 years old (or meet the legal adult age according to local regulations), and adolescent patients should be ≥12 years old and \\\u003C18 years old (or meet the legal definition of adolescent according to local regulations; additionally, adolescent patients should weigh ≥35 kg).\n3. The patient is diagnosed with PIK3CA-related overgrowth spectrum (PROS) or PIK3CA-related vascular malformations (PRVM), and provides a report confirming PIK3CA mutation detected by local laboratory or the Sponsor-designated central laboratory, with at least one measurable lesion related to PROS or PRVM.\n4. Patients should demonstrate adequate organ and bone marrow function during the 28-day screening period.\n\nKey exclusion criteria:\n\n1. PROS patients presenting solely with isolated macrodactyly, epidermal nevi\u002Fnevus, and megalencephaly (only one clinical feature or any combination of these three features) without other PROS-related lesions.\n2. Patients who have received any systemic treatment for PROS or PRVM within 8 weeks prior to the first dose of study drug, or any drug treatment for PROS or PRVM (e.g., mTOR inhibitors) within 28 days prior to the first dose of study drug.\n3. Patients who have previously received any PI3K inhibitor treatment.","ALL",{"count":294,"type":295},141,"ESTIMATED","INTERVENTIONAL",[298,299],"PHASE1","PHASE2","This study is a multi-center, open-label, single arm, phase I\u002FII 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)",[302,303],"PIK3CA-Related Overgrowth Spectrum (PROS)","PIK3CA-related Vascular Malformations (PRVM)","2026-06-26",{"date":306,"type":307},"2026-06-29","ACTUAL",{"date":309,"type":307},"2023-08-22",{"date":311,"type":295},"2029-12-31",{"name":5,"class":6},15]