[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572216":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":96,"collaborators":19,"id":98,"slug":19,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":19,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":19,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":19,"overallStatus":65,"whyStopped":19,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Akeso","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AK138D1","EXPERIMENTAL","AK138D1 will be administered in pre-specified dose levels.",[13],"Drug: AK138D1",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Wenting Li, MD","CONTACT","+86-18116403289","wenting01.li@akesobio.com",[27,48,63,80],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Blacktown Hospital-Blacktwon Cancer and Haematology Centre","NOT_YET_RECRUITING","Blacktown","New South Wales","2148","Australia",{"type":35,"coordinates":36},"Point",[37,38],150.91667,-33.76667,{"lat":38,"lon":37},[41,45],{"name":42,"role":23,"phone":43,"phoneExt":19,"email":44},"Adan Nagrial, MD","0288906859","adnan.nagrial@health.nsw.gov.au",{"name":46,"role":47,"phone":19,"phoneExt":19,"email":19},"Adnan Nagrial, MD","PRINCIPAL_INVESTIGATOR",{"facility":49,"status":29,"city":50,"state":31,"zip":51,"country":33,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Macquarie University","North Ryde","2109",{"type":35,"coordinates":53},[54,55],151.12436,-33.79677,{"lat":55,"lon":54},[58,62],{"name":59,"role":23,"phone":60,"phoneExt":19,"email":61},"Andrew Parsonson, MD","0298122956","andrew.parsonson@mqhealth.org.au",{"name":59,"role":47,"phone":19,"phoneExt":19,"email":19},{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":33,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"ICON Cancer Centre South Brisbane","RECRUITING","South Brisbane","Queensland","4101",{"type":35,"coordinates":70},[71,72],153.02049,-27.48034,{"lat":72,"lon":71},[75,79],{"name":76,"role":23,"phone":77,"phoneExt":19,"email":78},"Jermaine Coward, MD","0737374500","Jim.Coward@icon.team",{"name":76,"role":47,"phone":19,"phoneExt":19,"email":19},{"facility":81,"status":65,"city":82,"state":83,"zip":84,"country":33,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Peninsula & South Eastern Haematology and Oncology Group","Frankston","Victoria","3199",{"type":35,"coordinates":86},[87,88],145.12291,-38.14458,{"lat":88,"lon":87},[91,95],{"name":92,"role":23,"phone":93,"phoneExt":19,"email":94},"Vinod Ganju, MD","0397815244","vg@paso.com.au",{"name":92,"role":47,"phone":19,"phoneExt":19,"email":19},{"type":97,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100572216",false,"NCT06730386","A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors","A First-in-human, Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AK138D1 in the Treatment of Advanced Solid Tumors","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. Subjects who have histologically or cytologically diagnosed locally advanced or metastatic solid tumor, which Is refractory to or intolerant to standard treatment;\n6. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.\n7. Adequate organ function.\n\nExclusion Criteria:\n\n1. Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;\n2. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;\n3. Presence of active central nervous system (CNS) metastases.\n4. Patients with a history of non-infectious pneumonitis requiring systemic corticosteroid therapy; a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis); currently suffering from ILD\u002Fpneumonitis or suspected of having such diseases based on imaging during screening;\n5. 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;\n6. Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies\u002FmL (200 IU\u002FmL) and above the lower limit of detection). For HBsAg-positive subjects, anti-hepatitis B therapy is required during the study; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) is also an exclusion;\n7. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;\n8. Active syphilis infection;\n9. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;\n10. Other reasons for ineligibility as evaluated by the investigator.","ALL","18 Years","75 Years",{"count":108,"type":109},100,"ESTIMATED","INTERVENTIONAL",[112],"PHASE1","This is an open-label, first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK138D1 in subjects being treated for advanced solid tumors.",[115],"Solid Cancer","2025-03-04",{"date":118,"type":119},"2025-03-06","ACTUAL",{"date":121,"type":119},"2025-02-24",{"date":123,"type":109},"2028-08-30",{"name":5,"class":6},4]