[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572216":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":97,"collaborators":19,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":19,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":19,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":19,"overallStatus":66,"whyStopped":19,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"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",[27,49,64,81],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Blacktown Hospital-Blacktwon Cancer and Haematology Centre","NOT_YET_RECRUITING","Blacktown","New South Wales","2148","Australia","AU",{"type":36,"coordinates":37},"Point",[38,39],150.91667,-33.76667,{"lat":39,"lon":38},[42,46],{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Adan Nagrial, MD","0288906859","adnan.nagrial@health.nsw.gov.au",{"name":47,"role":48,"phone":19,"phoneExt":19,"email":19},"Adnan Nagrial, MD","PRINCIPAL_INVESTIGATOR",{"facility":50,"status":29,"city":51,"state":31,"zip":52,"country":33,"countryCode":34,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Macquarie University","North Ryde","2109",{"type":36,"coordinates":54},[55,56],151.12436,-33.79677,{"lat":56,"lon":55},[59,63],{"name":60,"role":23,"phone":61,"phoneExt":19,"email":62},"Andrew Parsonson, MD","0298122956","andrew.parsonson@mqhealth.org.au",{"name":60,"role":48,"phone":19,"phoneExt":19,"email":19},{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":33,"countryCode":34,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"ICON Cancer Centre South Brisbane","RECRUITING","South Brisbane","Queensland","4101",{"type":36,"coordinates":71},[72,73],153.02049,-27.48034,{"lat":73,"lon":72},[76,80],{"name":77,"role":23,"phone":78,"phoneExt":19,"email":79},"Jermaine Coward, MD","0737374500","Jim.Coward@icon.team",{"name":77,"role":48,"phone":19,"phoneExt":19,"email":19},{"facility":82,"status":66,"city":83,"state":84,"zip":85,"country":33,"countryCode":34,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Peninsula & South Eastern Haematology and Oncology Group","Frankston","Victoria","3199",{"type":36,"coordinates":87},[88,89],145.12291,-38.14458,{"lat":89,"lon":88},[92,96],{"name":93,"role":23,"phone":94,"phoneExt":19,"email":95},"Vinod Ganju, MD","0397815244","vg@paso.com.au",{"name":93,"role":48,"phone":19,"phoneExt":19,"email":19},{"type":98,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100572216","phase-1-a-phase-i-study-of-ak138d1-in-the-treatment-of-advanced-solid-tumors-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":110,"type":111},100,"ESTIMATED","INTERVENTIONAL",[114],"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.",[117],"Solid Cancer","2025-03-04",{"date":120,"type":121},"2025-03-06","ACTUAL",{"date":123,"type":121},"2025-02-24",{"date":125,"type":111},"2028-08-30",{"name":5,"class":6},4]