[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571122":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":67,"studyPopulation":67,"armGroups":74,"interventions":80,"overallOfficials":67,"centralContacts":86,"locations":92,"responsibleParty":141,"collaborators":67,"id":143,"slug":67,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":67,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":67,"enrollmentInfo":151,"targetDuration":67,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":95,"whyStopped":67,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Avistone Biotechnology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":67},[9,13,17,21,24],{"measure":10,"description":11,"timeFrame":12},"Incidence of Adverse Events (AEs)","Number of patients with adverse events by system organ class and preferred term","From the time of first dose to 28 days post last dose of ANS03",{"measure":14,"description":15,"timeFrame":16},"Incidence of Serious Adverse Events (SAEs)","Number of patients with serious adverse events by system organ class and preferred term","From time of first dose to 28 days post last dose of ANS03",{"measure":18,"description":19,"timeFrame":20},"Incidence of dose-limiting toxicities (DLT) as defined in the protocol","Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol","From time of first dose of ANS03 to end of DLT period (approximately 30 days)",{"measure":22,"description":23,"timeFrame":16},"Incidence of baseline laboratory finding, ECG and vital signs changes","measured by laboratory and vital sign variables over time including change from baseline",{"measure":25,"description":26,"timeFrame":27},"Proportion of patients with radiological response (ORR)","Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1","From date of first dose of ANS03 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)",[29,33,36,39,43,47,51,54,57,61,64],{"measure":30,"description":31,"timeFrame":32},"Objective Response Rate (ORR)","The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)","From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)",{"measure":34,"description":35,"timeFrame":32},"Duration of Response (DoR)","The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression",{"measure":37,"description":38,"timeFrame":32},"Disease Control Rate (DCR)","The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)",{"measure":40,"description":41,"timeFrame":42},"Progression free Survival (PFS)","The time from first dose until RECIST 1.1 defined disease progression or death due to any cause","From date of first dose of ANS03 up until date of progression or death due to any cause (approximately 2 years)]",{"measure":44,"description":45,"timeFrame":46},"Overall Survival (OS)","The time from the date of the first dose of study treatment until death due to any cause","From date of first dose of ANS03 up until the date of death due to any cause (approximately 2 years)",{"measure":48,"description":49,"timeFrame":50},"Pharmacokinetics of ANS03: Plasma PK concentrations","Measurement of plasma concentrations of ANS03, total antibody and total unconjugated warhead","From date of first dose up until 28 days post last dose",{"measure":52,"description":53,"timeFrame":50},"Pharmacokinetics of ANS03: Area under the concentration time curve (AUC)","Measurement of PK parameters: Area under the concentration time curve (AUC)",{"measure":55,"description":56,"timeFrame":50},"Pharmacokinetics of ANS03: Maximum plasma concentration of the study drug (C-max)","Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)",{"measure":58,"description":59,"timeFrame":60},"Pharmacokinetics of ANS03: Time to maximum plasma concentration of the study drug (T-max)","Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)","Frame: From date of first dose up until 28 days post last dose",{"measure":62,"description":63,"timeFrame":50},"Pharmacokinetics of ANS03: Clearance","Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)",{"measure":65,"description":66,"timeFrame":50},"Pharmacokinetics of ANS03: Half-life","Measurement of PK parameters: Terminal elimination half-life (t 1\u002F2)",null,{"allocation":69,"interventionModel":70,"interventionModelDescription":67,"primaryPurpose":71,"observationalModel":67,"timePerspective":67,"maskingInfo":72},"NA","SINGLE_GROUP","TREATMENT",{"masking":73,"maskingDescription":67,"whoMasked":67},"NONE",[75],{"label":76,"type":77,"description":67,"interventionNames":78},"ANS03 monotherapy","EXPERIMENTAL",[79],"Drug: ANS03",[81],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":67},"DRUG","ANS03","ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).",[76],[87],{"name":88,"role":89,"phone":90,"phoneExt":67,"email":91},"Avistone Clinical Study Information Center","CONTACT","8610 84148921","information.center@avistonebio.com",[93,106,117,125,133],{"facility":94,"status":95,"city":96,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":67},"Memorial Sloan Kettering Cancer Center","RECRUITING","New York","10022","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-74.00597,40.71427,{"lat":104,"lon":103},{"facility":107,"status":95,"city":108,"state":109,"zip":67,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":116,"contacts":67},"Research Site","Fuzhou","Fujian","China","CN",{"type":101,"coordinates":113},[114,115],119.30611,26.06139,{"lat":115,"lon":114},{"facility":107,"status":95,"city":118,"state":119,"zip":67,"country":110,"countryCode":111,"cosmosGeoPoint":120,"geoPoint":124,"contacts":67},"Guangzhou","Guangdong",{"type":101,"coordinates":121},[122,123],113.25,23.11667,{"lat":123,"lon":122},{"facility":107,"status":95,"city":126,"state":127,"zip":67,"country":110,"countryCode":111,"cosmosGeoPoint":128,"geoPoint":132,"contacts":67},"Shanghai","Shanghai Municipality",{"type":101,"coordinates":129},[130,131],121.45806,31.22222,{"lat":131,"lon":130},{"facility":107,"status":95,"city":134,"state":135,"zip":67,"country":110,"countryCode":111,"cosmosGeoPoint":136,"geoPoint":140,"contacts":67},"Chengdu","Sichuan",{"type":101,"coordinates":137},[138,139],104.06667,30.66667,{"lat":139,"lon":138},{"type":142,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR","100571122",false,"NCT06716138","A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS03 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2\n* Life expectancy ≥ 12 weeks\n* Measurable disease per RECIST v1.1\n* Adequate organ and marrow function as defined in the protocol\n* With documentation of ROS1 or NTRK alteration\n\nExclusion Criteria:\n\n* Active infection including tuberculosis and HBV, HCV or HIV\n* Known active or untreated CNS metastases\n* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression\n* Participants with serious cardiovascular or cerebrovascular diseases","ALL","18 Years",{"count":152,"type":153},96,"ESTIMATED","INTERVENTIONAL",[156],"PHASE1","This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.",[159],"Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration",[161,83,162,163],"ROS1\u002FNTRK","ROS1","NTRK","2026-03-11",{"date":166,"type":167},"2026-03-13","ACTUAL",{"date":169,"type":167},"2025-03-06",{"date":171,"type":153},"2029-03-30",{"name":5,"class":6},5]