[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620843":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":100,"collaborators":19,"id":102,"slug":19,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":19,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":19,"enrollmentInfo":110,"targetDuration":19,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Adcendo ApS","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ADCE-B05","EXPERIMENTAL","Dose escalation followed by a dose expansion phase. ADCE-B05 is administered intravenously on a 3 weekly dosing cycle",[13],"Drug: ADCE-B05",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Biological: Antibody-drug conjugate (ADC)",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Charlotte Lybek Lind","CONTACT","+45 26461897","charlotte.lind@adcendo.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Margaret McNaull","+44 7818457619","margaret.mcnaull@adcendo.com",[31,44,54,64,75,85,90],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":19},"Highlands Oncology Group","RECRUITING","Springdale","Arkansas","72762","United States",{"type":39,"coordinates":40},"Point",[41,42],-94.12881,36.18674,{"lat":42,"lon":41},{"facility":45,"status":33,"city":46,"state":47,"zip":48,"country":37,"cosmosGeoPoint":49,"geoPoint":53,"contacts":19},"Yale University","New Haven","Connecticut","06520",{"type":39,"coordinates":50},[51,52],-72.92816,41.30815,{"lat":52,"lon":51},{"facility":55,"status":33,"city":56,"state":57,"zip":58,"country":37,"cosmosGeoPoint":59,"geoPoint":63,"contacts":19},"University Of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":39,"coordinates":60},[61,62],-95.36327,29.76328,{"lat":62,"lon":61},{"facility":65,"status":33,"city":66,"state":67,"zip":68,"country":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":19},"Scientia Clinical Research","Randwick","New South Wales","2031","Australia",{"type":39,"coordinates":71},[72,73],151.24895,-33.91439,{"lat":73,"lon":72},{"facility":76,"status":33,"city":77,"state":78,"zip":79,"country":69,"cosmosGeoPoint":80,"geoPoint":84,"contacts":19},"Southern Oncology Clinical Research Unit","Bedford Park","South Australia","5042",{"type":39,"coordinates":81},[82,83],138.56815,-35.02204,{"lat":83,"lon":82},{"facility":86,"status":87,"city":88,"state":78,"zip":89,"country":69,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Monash Health","NOT_YET_RECRUITING","Clayton","3165",{"facility":91,"status":33,"city":92,"state":93,"zip":94,"country":69,"cosmosGeoPoint":95,"geoPoint":99,"contacts":19},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3000",{"type":39,"coordinates":96},[97,98],144.96332,-37.814,{"lat":98,"lon":97},{"type":101,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100620843",false,"NCT07362888","First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors","A First-in-Human, Phase 1a\u002F1b, Open-Label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of the Antibody Drug Conjugate ADCE-B05 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of solid tumor\n* Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies\n* Radiologically or clinically determined progressive disease during or after most recent line of therapy\n* Measurable disease per RECIST 1.1\n* ECOG performance status of 0 or 1\n* Adequate hematological and biochemical parameters\n* A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate\n* A female patient who is not pregnant, not breast feeding, and either not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment\n\nExclusion Criteria\n\n* Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration\n* Prior treatment with an ADC containing a topoisomerase I inhibitor payload\n* Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required\n* Other malignancy\n* Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration\n* Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment\n* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1\n* Clinically significant cardiovascular disease\n* Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2\n* Current active liver disease due to hepatitis B or hepatitis C\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis","ALL","18 Years",{"count":111,"type":112},180,"ESTIMATED","INTERVENTIONAL",[115],"PHASE1","The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.",[118],"Solid Tumors (Phase 1)","2026-07-01",{"date":121,"type":122},"2026-07-02","ACTUAL",{"date":124,"type":122},"2026-03-17",{"date":126,"type":112},"2029-03-14",{"name":5,"class":6},7]