[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603935":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":11,"studyPopulation":11,"armGroups":50,"interventions":57,"overallOfficials":11,"centralContacts":63,"locations":72,"responsibleParty":94,"collaborators":11,"id":96,"slug":11,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":11,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":11,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":11,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":11},[9,13,15,18,20],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of adverse events (AEs)",null,"From screening period up to 30 days after the last dose.",{"measure":14,"description":11,"timeFrame":12},"Incidence and severity of serious adverse events (SAEs)",{"measure":16,"description":11,"timeFrame":17},"Dose-limiting toxicity (DLT)","From day 1 to day 24.",{"measure":19,"description":11,"timeFrame":17},"Maximum tolerated dose (MTD)",{"measure":21,"description":11,"timeFrame":17},"Recommended Phase II Dose (RP2D)",[23,26,28,30,32,34,36,38,40,42],{"measure":24,"description":11,"timeFrame":25},"Objective response rate (ORR)","About 24 months.",{"measure":27,"description":11,"timeFrame":25},"Duration of response (DoR)",{"measure":29,"description":11,"timeFrame":25},"Disease control rate (DCR)",{"measure":31,"description":11,"timeFrame":25},"Progression-free survival (PFS)",{"measure":33,"description":11,"timeFrame":25},"Overall survival (OS)",{"measure":35,"description":11,"timeFrame":25},"Maximum plasma concentration (Cmax)",{"measure":37,"description":11,"timeFrame":25},"Time to maximum concentration (Tmax)",{"measure":39,"description":11,"timeFrame":25},"Elimination half-life (t1\u002F2)",{"measure":41,"description":11,"timeFrame":25},"Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t)",{"measure":43,"description":11,"timeFrame":25},"Area under concentration-time curve from time 0 to infinity (AUC0-∞)",{"allocation":45,"interventionModel":46,"interventionModelDescription":11,"primaryPurpose":47,"observationalModel":11,"timePerspective":11,"maskingInfo":48},"NA","SINGLE_GROUP","TREATMENT",{"masking":49,"maskingDescription":11,"whoMasked":11},"NONE",[51],{"label":52,"type":53,"description":54,"interventionNames":55},"HRS-7172 Group","EXPERIMENTAL","Oral HRS-7172.",[56],"Drug: HRS-7172 Tablets",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":11},"DRUG","HRS-7172 Tablets","HRS-7172 tablets.",[52],[64,69],{"name":65,"role":66,"phone":67,"phoneExt":11,"email":68},"Rongfu Mao","CONTACT","+86-021-61053363","rongfu.mao@hengrui.com",{"name":70,"role":66,"phone":67,"phoneExt":11,"email":71},"Jizhao Li","jizhao.li.jl565@hengrui.com",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Fudan University Affiliated Cancer Hospital","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":82,"coordinates":83},"Point",[84,85],121.45806,31.22222,{"lat":85,"lon":84},[88,92],{"name":89,"role":66,"phone":90,"phoneExt":11,"email":91},"Xianjun Yu","+86-021-64175590","yuxianjun@fudanpci.org",{"name":89,"role":93,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":95,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100603935",false,"NCT07142980","A Phase I Study of HRS-7172 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications","A Phase I Study of HRS-7172 Evaluating Safety, Tolerability and Pharmacokinetics in Participants 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. ECOG performance status (PS) score of 0 or 1;\n4. Life expectancy \\> 3 months;\n5. At least one measurable lesion per RECIST v1.1;\n6. Adequate organ function.\n\nExclusion Criteria:\n\n1. 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":106,"type":107},120,"ESTIMATED","INTERVENTIONAL",[110],"PHASE1","This is a phase I study of HRS-7172 to evaluate safety, tolerability and pharmacokinetics in participants with advanced solid tumors harboring RAS mutations or amplifications.",[113],"Advanced Solid Tumors Harboring RAS Mutations or Amplifications","2025-11-13",{"date":116,"type":117},"2025-11-17","ACTUAL",{"date":119,"type":117},"2025-09-12",{"date":121,"type":107},"2028-12",{"name":5,"class":6},1]