[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525686":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":27,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":27,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":27,"enrollmentInfo":67,"targetDuration":27,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":27,"overallStatus":41,"whyStopped":27,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Shanghai Jiatan Pharmatech Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"WX390 + Toripalimab","EXPERIMENTAL","Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240 mg, intravenous, Day 1, every 3 weeks).",[13,14],"Drug: WX390","Drug: Toripalimab",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","WX390","WX390 tablet, 0.9 mg once a day",[9],[22],"WXFL10030390",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Toripalimab","240 mg, Day 1, every 3 weeks",[9],null,[29],{"name":30,"affiliation":31,"role":32},"Yu Kang, PhD","The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":27,"email":38},"Gaoli He","CONTACT","008621-63453967","fcklcsyjg@163.com",[40],{"facility":31,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Shanghai","Shanghai Municipality","200090","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54,55],{"name":30,"role":36,"phone":27,"phoneExt":27,"email":27},{"name":30,"role":32,"phone":27,"phoneExt":27,"email":27},{"type":57,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100525686","phase-2-a-study-of-wx390-combined-with-toripalimab-in-patients-with-advanced-gastric-type-endocervical-adenocarcinoma-with-stk11-mutations-100525686",false,"NCT06124963","A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations","A Phase II Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations","Inclusion Criteria:\n\n* ≥18 years of age\n* Histological or cytological confirmed advanced Gastric-type Endocervical Adenocarcinoma.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy of more than 3 months\n* At least one measurable lesion according to RECIST 1.1\n* Adequate organic function\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 30 days prior to the initiation of investigational treatment\n* Major surgery within 30 days prior to the initiation of study treatment\n* Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment\n* Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)\n* Patients who are suffering active interstitial lung disease\n* Evidence of ongoing or active serious infection\n* History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection\n* Inability to take medication orally\n* Abuse of alcohol or drugs\n* People with cognitive and psychological abnormality or with low compliance\n* Pregnant or lactating women","FEMALE","18 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced Gastric-type Endocervical Adenocarcinoma with STK11 mutations. The main questions it aims to answer are:\n\n* Pharmacokinetic (PK) characteristics of WX390 combined with Toripalimab treatment.\n* Safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.",[75],"Gastric Type Adenocarcinoma (GAS) With STK11 Mutation","2024-12-09",{"date":78,"type":79},"2024-12-10","ACTUAL",{"date":81,"type":79},"2023-08-25",{"date":83,"type":69},"2026-12-09",{"name":5,"class":6},1]