[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558609":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":38,"locations":43,"responsibleParty":59,"collaborators":32,"id":61,"slug":32,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":32,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":32,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase Ia dose escalation arm","EXPERIMENTAL","Participants will be assigned to pre-specified dose level to identify the MTD\u002FMAD of HS-10516.",[13],"Drug: Oral HS-10516",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase Ib dose expansion arm 1","Participants with VHL Syndrome associated RCC, whose lesions diameter ≤ 3 cm.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Phase Ib dose expansion arm 2","Participants with VHL Syndrome associated RCC, who could not be included in arm 1.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Phase Ib dose expansion arm 3","Participants with VHL Syndrome associated non-RCC tumors.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Oral HS-10516","Oral HIF-2α inhibitor",[9,15,19,23],null,[34],{"name":35,"affiliation":36,"role":37},"Kan Gong, PhD","Peking University First Hospital","PRINCIPAL_INVESTIGATOR",[39],{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},"CONTACT","13910394281","kan.gong@bjmu.edu.cn",[44],{"facility":36,"status":45,"city":46,"state":47,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Beijing","Beijing Municipality","100034","China",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":35,"role":40,"phone":58,"phoneExt":32,"email":42},"(0086)13910394281",{"type":60,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100558609",false,"NCT06553339","A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors","A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy","Inclusion Criteria:\n\n1. Male or female from 18 to 80 year-old\n2. Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors\n3. Has an Eastern Cooperative Oncology Group performance status of 0-1\n4. Has a life expectancy of ≥ 12 weeks\n5. Should use adequate contraceptive measures throughout the study\n6. Females subject must not be pregnant at screening\n7. Has the ability to understand and willingness to sign a written informed consent before the performance of the study.\n\nExclusion Criteria:\n\n1. Recieved or being received treatment as follows:\n\n   1. Hypoxia-induced factor inhibitors\n   2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.\n   3. Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment\n   4. Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment\n   5. Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.\n   6. Major surgery within 4 weeks prior to the first dose of study treatment.\n2. Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen\n3. Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy\n4. Has another malignancy or a history of another non-VHL syndrome associated malignancy\n5. Has inadequate bone marrow reserve or organ dysfunction\n6. Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment\n7. Has severe infections within 4 weeks prior to the first dose of study treatment\n8. Has digestive system diseases may influencing ADME of study drug\n9. Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolin\n10. Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision","ALL","18 Years","80 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","The aim of the Phase Ia portion is to identify the maximum tolerated dose or maximum acceptable dose MTD\u002FMAD of HS-10516. The phase Ib portion will evaluate the preliminary efficacy of HS-10516 in patients with VHL Syndrome Associated Tumors.",[78],"Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma",[80,81,82,83,84],"Von Hippel Lindau Syndrome","VHL Syndrome","RCC","pNET","CNS hemangioblastoma","2024-08-12",{"date":87,"type":88},"2024-08-14","ACTUAL",{"date":90,"type":88},"2024-07-19",{"date":92,"type":72},"2028-07-31",{"name":5,"class":6},1]