[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607545":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HRS-2329 Group","EXPERIMENTAL",null,[13],"Drug: HRS-2329 Tablet",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","HRS-2329 Tablet","Oral HRS-2329 tablet.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Rongfu Mao","CONTACT","+86 021-61053363","rongfu.mao@hengrui.com",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Jizhao Li","+86-021-61053363","jizhao.li.jl565@hengrui.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Tianjin Medical University Cancer Institute and Hospital","RECRUITING","Tianjin","Tianjin Municipality","300181","China","CN",{"type":40,"coordinates":41},"Point",[42,43],117.17667,39.14222,{"lat":43,"lon":42},[46,50],{"name":47,"role":23,"phone":48,"phoneExt":11,"email":49},"Jihui Hao","+86-022-23340123","haojihui@tjmuch.com",{"name":47,"role":51,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100607545","phase-1-a-study-of-hrs-2329-in-participants-with-advanced-solid-tumors-harboring-ras-mutations-or-amplifications-100607545",false,"NCT07189949","A Study of HRS-2329 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications","A Phase I Study of HRS-2329 Evaluating Safety, Tolerability, and Pharmacokinetics in Subjects With Advanced Solid Tumors Harboring RAS Mutations or Amplifications","Inclusion Criteria:\n\n1. Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;\n2. Aged between 18-75 years old;\n3. Participants with histologically\u002Fcytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor RAS mutations or amplifications and have failed standard treatment;\n4. ECOG performance status (PS) score of 0 or 1;\n5. Life expectancy \\> 3 months;\n6. At least one measurable lesion per RECIST v1.1;\n7. Adequate organ function.\n\nExclusion Criteria:\n\n1. Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion\u002Fexclusion criteria;\n2. Presence of central nervous system (CNS) metastases;\n3. Participants with gastrointestinal diseases that affect drug administration\u002Fabsorption;\n4. Participants who have undergone major surgery other than diagnosis or biopsy within 28 days before the first dose, or are expected to undergo major surgery during the study period;\n5. Presence of serious pulmonary diseases;\n6. Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;\n7. Active or persistent gastrointestinal bleeding within 6 months prior to screening;\n8. History of allogeneic bone marrow or solid organ transplantation;\n9. History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;\n10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;\n11. Positive human immunodeficiency virus (HIV) (HIV1\u002F2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA);\n12. Known history of hypersensitivity to any component of the drug product to be used in the study.","ALL","18 Years","75 Years",{"count":65,"type":66},120,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","This is an open-label, multi-center phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of HRS-2329 in participants with advanced solid tumors harboring RAS mutations or amplifications.",[72],"Advanced Solid Tumors Harboring RAS Mutations or Amplifications","2026-03-05",{"date":75,"type":76},"2026-03-06","ACTUAL",{"date":78,"type":76},"2025-10-16",{"date":80,"type":66},"2028-12",{"name":5,"class":6},1]