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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",[31,45,55,65,77,87,92],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":19},"Highlands Oncology Group","RECRUITING","Springdale","Arkansas","72762","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-94.12881,36.18674,{"lat":43,"lon":42},{"facility":46,"status":33,"city":47,"state":48,"zip":49,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":54,"contacts":19},"Yale University","New Haven","Connecticut","06520",{"type":40,"coordinates":51},[52,53],-72.92816,41.30815,{"lat":53,"lon":52},{"facility":56,"status":33,"city":57,"state":58,"zip":59,"country":37,"countryCode":38,"cosmosGeoPoint":60,"geoPoint":64,"contacts":19},"University Of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":40,"coordinates":61},[62,63],-95.36327,29.76328,{"lat":63,"lon":62},{"facility":66,"status":33,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":19},"Scientia Clinical Research","Randwick","New South Wales","2031","Australia","AU",{"type":40,"coordinates":73},[74,75],151.24895,-33.91439,{"lat":75,"lon":74},{"facility":78,"status":33,"city":79,"state":80,"zip":81,"country":70,"countryCode":71,"cosmosGeoPoint":82,"geoPoint":86,"contacts":19},"Southern Oncology Clinical Research Unit","Bedford Park","South Australia","5042",{"type":40,"coordinates":83},[84,85],138.56815,-35.02204,{"lat":85,"lon":84},{"facility":88,"status":89,"city":90,"state":80,"zip":91,"country":70,"countryCode":71,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Monash Health","NOT_YET_RECRUITING","Clayton","3165",{"facility":93,"status":33,"city":94,"state":95,"zip":96,"country":70,"countryCode":71,"cosmosGeoPoint":97,"geoPoint":101,"contacts":19},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3000",{"type":40,"coordinates":98},[99,100],144.96332,-37.814,{"lat":100,"lon":99},{"type":103,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100620843","phase-1-first-in-human-study-of-adce-b05-in-patients-with-advanced-solid-tumors-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":114,"type":115},180,"ESTIMATED","INTERVENTIONAL",[118],"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.",[121],"Solid Tumors (Phase 1)","2026-07-01",{"date":124,"type":125},"2026-07-02","ACTUAL",{"date":127,"type":125},"2026-03-17",{"date":129,"type":115},"2029-03-14",{"name":5,"class":6},7]