[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525931":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":75,"centralContacts":50,"locations":80,"responsibleParty":101,"collaborators":50,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":50,"enrollmentInfo":113,"targetDuration":50,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":83,"whyStopped":50,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Guangzhou JOYO Pharma Co., Ltd","INDUSTRY",[8,14,19,24,29,34,39],{"label":9,"type":10,"description":11,"interventionNames":12},"50 mg qd","EXPERIMENTAL","Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 50 mg qd. This arm evaluates the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of this dose level.",[13],"Drug: JYP0322 50 mg qd",{"label":15,"type":10,"description":16,"interventionNames":17},"100 mg qd","Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 100 mg qd. This arm assesses safety, tolerability, and pharmacokinetics (PK) data for this dose level.",[18],"Drug: JYP0322 100 mg qd",{"label":20,"type":10,"description":21,"interventionNames":22},"200 mg qd","Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 200 mg qd. This arm examines the safety, pharmacokinetics (PK), and preliminary efficacy of this dose level.",[23],"Drug: JYP0322 200 mg qd",{"label":25,"type":10,"description":26,"interventionNames":27},"100 mg bid","Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 100 mg bid. The arm evaluates the safety, tolerability, and pharmacokinetics (PK) of this increased dosing frequency.",[28],"Drug: JYP0322 100 mg bid",{"label":30,"type":10,"description":31,"interventionNames":32},"150 mg bid","Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 150 mg bid. This arm aims to determine the optimal dosing for safety, pharmacokinetics (PK), and efficacy.",[33],"Drug: JYP0322 150 mg bid",{"label":35,"type":10,"description":36,"interventionNames":37},"200 mg bid","Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 200 mg bid. This arm focuses on evaluating safety, tolerability, and pharmacokinetics (PK) at this dose.",[38],"Drug: JYP0322 200 mg bid",{"label":40,"type":10,"description":41,"interventionNames":42},"150 mg tid","Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 150 mg tid. This arm focuses on evaluating safety, tolerability, and pharmacokinetics (PK) at this dose.",[43],"Drug: JYP0322 150mg tid",[45,51,55,59,63,67,71],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","JYP0322 50 mg qd","JYP0322 is administered orally at a dose of 50 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.",[9],null,{"type":46,"name":52,"description":53,"armGroupLabels":54,"otherNames":50},"JYP0322 100 mg qd","JYP0322 is administered orally at a dose of 100 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.",[15],{"type":46,"name":56,"description":57,"armGroupLabels":58,"otherNames":50},"JYP0322 200 mg qd","JYP0322 is administered orally at a dose of 200 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.",[20],{"type":46,"name":60,"description":61,"armGroupLabels":62,"otherNames":50},"JYP0322 100 mg bid","JYP0322 is administered orally at a dose of 100 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.",[25],{"type":46,"name":64,"description":65,"armGroupLabels":66,"otherNames":50},"JYP0322 150 mg bid","JYP0322 is administered orally at a dose of 150 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.",[30],{"type":46,"name":68,"description":69,"armGroupLabels":70,"otherNames":50},"JYP0322 200 mg bid","JYP0322 is administered orally at a dose of 200 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.",[35],{"type":46,"name":72,"description":73,"armGroupLabels":74,"otherNames":50},"JYP0322 150mg tid","JYP0322 is administered orally at a dose of 150 mg tid for a specified duration until unacceptable toxicity, disease progression, or study completion.",[40],[76],{"name":77,"affiliation":78,"role":79},"Li Zhang, M.D.","Sun Yat-sen University","PRINCIPAL_INVESTIGATOR",[81],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Sun Yat-Sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":90,"coordinates":91},"Point",[92,93],113.25,23.11667,{"lat":93,"lon":92},[96],{"name":97,"role":98,"phone":99,"phoneExt":50,"email":100},"Su Li","CONTACT","+86 020-87343990","lisu@sysucc.org.cn",{"type":102,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100525931","phase-1-phase-i-study-of-jyp0322-in-ros1-fusion-positive-solid-tumors-100525931",false,"NCT06128148","Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors","JYP0322","Key Inclusion Criteria\n\n* Adult patients age 18 years or older.\n* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a ROS1 molecular fusion.\n* Measurable disease according to RECIST version 1.1\n* Life expectancy of at least 3 months\n* Other protocol specified criteria\n\nKey Exclusion Criteria:\n\n* Current participation in another therapeutic clinical trial.\n* Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.\n* A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.\n* Known active infections (bacterial, viral including HIV positivity).\n* Other protocol specified criteria","ALL","18 Years",{"count":114,"type":115},101,"ESTIMATED","INTERVENTIONAL",[118],"PHASE1","An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced\u002Fmetastatic solid tumors .",[121,122,123,124],"Protein Kinase Inhibitors","Other Protocol Specified Criteria","Lung Neoplasms","Brain Neoplasms",[126,127,128,129],"ROS1 Fusions","ROS1 Gene Rearrangements","Primary brain tumors","ROS1","2025-07-09",{"date":132,"type":133},"2025-07-14","ACTUAL",{"date":135,"type":133},"2022-05-04",{"date":137,"type":115},"2027-12-30",{"name":5,"class":6},1]