[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636010":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":50,"locations":56,"responsibleParty":93,"collaborators":30,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":30,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":30,"studyType":108,"phases":109,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":117,"whyStopped":30,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Akeso","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"AK138D1","EXPERIMENTAL","AK138D1 will be administered at pre-specified dose levels.",[13],"Drug: AK138D1",{"label":15,"type":10,"description":16,"interventionNames":17},"AK138D1+ivonescimab","AK138D1 and ivonescimab will be administered at pre-specified dose levels.",[13,18],"Drug: Ivonescimab",{"label":20,"type":21,"description":22,"interventionNames":23},"Treatment of Physician's Choice","ACTIVE_COMPARATOR","Treatment of physician's choice will be administered according to one of the protocol-specified regimens selected by the investigator.",[24],"Drug: treatment of physician's choice",[26,31,35],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.",[9,15],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Ivonescimab","Enrolled subjects will receive intravenous infusion (IV) of ivonescimab according to the dosing regimen specified in their cohort.",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"treatment of physician's choice","Enrolled subjects will receive treatment of physician's choice according to one of the protocol-specified regimens selected by the investigator, based on the investigator's decision.",[20],[40,44,47],{"name":41,"affiliation":42,"role":43},"Fei Ma","Cancer Institute and Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":43},"Tong Liu","The Second Affiliated Hospital of Harbin Medical University",{"name":48,"affiliation":49,"role":43},"Ting Luo","West China Hospital",[51],{"name":52,"role":53,"phone":54,"phoneExt":30,"email":55},"Wenting Li","CONTACT","+86(0760)89873999","clinicaltrials@akesobio.com",[57,71,82],{"facility":58,"status":30,"city":59,"state":60,"zip":30,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Cancer Hospital Chinese Academy of Medical Sciences","Beijing","Beijing Municipality","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},[70],{"name":41,"role":53,"phone":30,"phoneExt":30,"email":30},{"facility":72,"status":30,"city":73,"state":74,"zip":30,"country":61,"countryCode":62,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Harbin Medical University Cancer Hospital","Harbin","Heilongjiang",{"type":64,"coordinates":76},[77,78],126.65,45.75,{"lat":78,"lon":77},[81],{"name":45,"role":53,"phone":30,"phoneExt":30,"email":30},{"facility":83,"status":30,"city":84,"state":85,"zip":30,"country":61,"countryCode":62,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"West China Hospital of Sichuan University","Chengdu","Sichuan",{"type":64,"coordinates":87},[88,89],104.06667,30.66667,{"lat":89,"lon":88},[92],{"name":48,"role":53,"phone":30,"phoneExt":30,"email":30},{"type":94,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100636010","phase-1-a-study-of-ak138d1-alone-or-in-combination-with-ivonescimab-in-advanced-breast-cancer-100636010",false,"NCT07560124","A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer","A Phase Ib\u002FII Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Breast Cancer","Inclusion Criteria:\n\n1. The subject must sign the written informed consent form (ICF) voluntarily;\n2. At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;\n3. ECOG performance status score of 0 or 1;\n4. Has a life expectancy of ≥ 3 months;\n5. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.\n6. Adequate organ function.\n\nExclusion Criteria:\n\n1. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;\n2. Presence of active central nervous system (CNS) metastases.\n3. Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;\n4. Untreated subjects with active hepatitis B or active hepatitis C;\n5. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;\n6. Known active syphilis infection;\n7. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;\n8. Other reasons for ineligibility as evaluated by the investigator.","ALL","18 Years","75 Years",{"count":106,"type":107},286,"ESTIMATED","INTERVENTIONAL",[110,111],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced breast cancer.\n\nParticipants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.",[114],"Breast Cancer",[116],"Breast cancer","NOT_YET_RECRUITING","2026-04-24",{"date":120,"type":121},"2026-04-30","ACTUAL",{"date":123,"type":107},"2026-06-06",{"date":125,"type":107},"2030-09-14",{"name":5,"class":6},3]