[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464700":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":32,"responsibleParty":52,"collaborators":19,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":19,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":19,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":19,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Shanghai Kechow Pharma, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HL-085","EXPERIMENTAL","HL-085 9mg BID",[13],"Drug: HL-085",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","IIa: HL-085 capsule 9mg administered orally twice daily in a continuous 21-day treatment cycle. If required, dosing schedule can be adjusted to 12mg BID, 6mg BID, or other dosage regimens.\n\nIIb: HL-085 at the recommended dose or dosage regimen.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Hongqi Tian, Ph.D","STUDY_CHAIR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Zhimei Zhu, Master","CONTACT","86 215201345822","zhuzm@kechowpharma.com",{"name":22,"role":27,"phone":19,"phoneExt":19,"email":31},"tianhq@kechowpharma.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200011","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48],{"name":49,"role":27,"phone":50,"phoneExt":19,"email":51},"Qingfeng Li, M.D.","13301990666","dr.liqingfeng@shsmu.edu.cn",{"type":53,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100464700","phase-2-hl-085-in-adults-with-neurofibromatosis-type-1-nf1-and-inoperable-plexiform-neurofibromas-100464700",false,"NCT05331105","HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas","A Multi-center, Open-label, Single-arm Phase II Study to Evaluate the Efficacy and Safety of HL-085 in the Treatment of Adult Participants With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas","Inclusion Criteria:\n\n* Age: patients must be ≥18 years of age at the time of study entry.\n* Diagnosis: Patients must have inoperable and symptomatic plexiform neurofibromas(PN), and patients must have NF1 mutation or meet at least 1 of the following NF1 diagnostic criteria:\n\n  ① ≥6 cafe-au-lait macules ;\n\n  ② Axillary freckling or freckling in inguinal regions;\n\n  ③ ≥2 Lisch nodules (iris hamartomas);\n\n  ④ A distinctive bony lesion such as dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex);\n\n  ⑤ An optic pathway glioma;\n\n  ⑥ First-degree relative with NF1.\n* Patients must have a measurable lesion, defined as at least 3 cm in length, amenable to MRI for efficacy assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patients are able to understand and voluntarily sign a written informed consent form.\n* Patients must be willing and able to complete study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n* Patients who are unable to undergo MRI scans (prosthesis, prosthesis, braces, etc.) or patients with lesions that cannot be evaluated by MRI.\n* Patients do not have adequate organ function.\n* Patients who are unable to take drugs orally, have difficulty swallowing or anything that may lead to inadequate drug absorption.\n* Prior treatment with MEK 1\u002F2 inhibitors.\n* Patients known to be allergic to the ingredients or analogues of the study drug.\n* Patients with previous or current retinal diseases such as retinal vein occlusion (RVO), retinal pigment epithelium detachment (RPED), central serous retinopathy (CSR), etc. (except retinopathy caused by research diseases).\n* With infections or other uncontrolled disease.\n* Strong CYP2C9 inhibitors or inducers within 7 days before treatment of the study drug.\n* Patients who received surgery within 4 weeks or radiotherapy within 6 weeks before enrollment.\n* Patients who participated in any other clinical study treatment within 4 weeks before enrollment.\n* Patients treated with anti-NF1 treatment with unresolved chronic toxicity.\n* Clinical judgment by the investigator that the patient should not participate in the study.","ALL","18 Years","80 Years",{"count":65,"type":66},70,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This is a Multi-center, Open-label, Single-arm Phase II Study to Evaluate the Efficacy and Safety of HL-085 in the treatment of Adult Participants with Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas(PN)",[72,73],"Neurofibromatosis 1","Plexiform Neurofibromas","2023-05-29",{"date":76,"type":77},"2023-05-31","ACTUAL",{"date":79,"type":77},"2021-10-18",{"date":81,"type":66},"2028-10-31",{"name":5,"class":6},1]