[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07362888":3,"trial-entities:NCT07362888":177,"trial-summary:NCT07362888":79},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":43,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":15,"eligibility_criteria":80,"std_ages":103,"locations":106,"central_contacts":164,"overall_officials":174,"references":175,"see_also_links":176},"NCT07362888","ADCE-B05-001","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","RECRUITING","2029-03-14","2026-07","2026-07-24","2026-03-17","Adcendo ApS","INDUSTRY",false,"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.","Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1",[19],"Solid Tumors (Phase 1)",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},180,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","ADCE-B05","Biological: Antibody-drug conjugate (ADC)",[31],[35,39],{"measure":36,"description":37,"timeFrame":38},"Determine the MTD\u002Fmaximum administered dose of ADCE-B05","Incidence of dose-limiting toxicities (DLTs)","From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)",{"measure":40,"description":41,"timeFrame":42},"Assess the safety and tolerability of ADCE-B05","Nature, incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0).\n\nTolerability as assessed by TEAEs leading to dose interruption, reduction and\u002For discontinuation","Throughout the trial duration, completion expected approximately 18 months from completed enrollment",[44,47,50,53,56,59,62,65,68,71,74],{"measure":45,"description":46,"timeFrame":42},"Maximum concentration (Cmax)","The maximum concentration (Cmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05",{"measure":48,"description":49,"timeFrame":42},"Time to maximum concentration (Tmax)","The time to maximum concentration (Tmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05",{"measure":51,"description":52,"timeFrame":42},"Terminal half-life (T[1\u002F2])","The terminal half-life (T\\[1\u002F2\\]) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05",{"measure":54,"description":55,"timeFrame":42},"Area under the concentration-time curve (AUC)","The area under the concentration-time curve (AUC) will be assessed to characterize PK profile of ADCE-B05",{"measure":57,"description":58,"timeFrame":42},"Total antibody (TAb)","The total antibody will be assessed to characterize the Pharmacokinetic profile of ADCE-B05",{"measure":60,"description":61,"timeFrame":42},"Free (de-conjugated) payload","The free (de-conjugated) payload will be assessed to characterize PK profile of ADCE-B05",{"measure":63,"description":64,"timeFrame":42},"Objective response rate (ORR)","Objective response rate (ORR) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity",{"measure":66,"description":67,"timeFrame":42},"Duration of response (DOR)","Duration of response DOR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity",{"measure":69,"description":70,"timeFrame":42},"Progression-free survival (PFS)","Progression-free survival (PFS) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity",{"measure":72,"description":73,"timeFrame":42},"Disease Control Rate (DCR)","DCR will be assessed by investigator per RECIST v1.1 to evaluate preliminary antitumor activity",{"measure":75,"description":76,"timeFrame":42},"Time to Response (TTR)","TTR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity","ALL","18 Years",null,{"inclusion":81,"exclusion":90,"raw_text":102},[82,83,84,85,86,87,88,89],"Histologically or cytologically confirmed diagnosis of solid tumor","Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies","Radiologically or clinically determined progressive disease during or after most recent line of therapy","Measurable disease per RECIST 1.1","ECOG performance status of 0 or 1","Adequate hematological and biochemical parameters","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","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",[91,92,93,94,95,96,97,98,99,100,101],"Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration","Prior treatment with an ADC containing a topoisomerase I inhibitor payload","Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required","Other malignancy","Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration","Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment","Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1","Clinically significant cardiovascular disease","Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2","Current active liver disease due to hepatitis B or hepatitis C","History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis","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",[104,105],"ADULT","OLDER_ADULT",[107,116,124,132,141,149,157],{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":112,"geoPoint":113},"Highlands Oncology Group","Springdale","Arkansas","72762","United States",{"lat":114,"lon":115},36.18674,-94.12881,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":112,"geoPoint":121},"Yale University","New Haven","Connecticut","06520",{"lat":122,"lon":123},41.30815,-72.92816,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":112,"geoPoint":129},"University Of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"lat":130,"lon":131},29.76328,-95.36327,{"facility":133,"status":8,"city":134,"state":135,"zip":136,"country":137,"geoPoint":138},"Scientia Clinical Research","Randwick","New South Wales","2031","Australia",{"lat":139,"lon":140},-33.91439,151.24895,{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":137,"geoPoint":146},"Southern Oncology Clinical Research Unit","Bedford Park","South Australia","5042",{"lat":147,"lon":148},-35.02204,138.56815,{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":137,"geoPoint":154},"Monash Health","Clayton","Victoria","3165",{"lat":155,"lon":156},-37.91667,145.11667,{"facility":158,"status":8,"city":159,"state":152,"zip":160,"country":137,"geoPoint":161},"Peter MacCallum Cancer Centre","Melbourne","3000",{"lat":162,"lon":163},-37.814,144.96332,[165,170],{"name":166,"role":167,"phone":168,"email":169},"Charlotte Lybek Lind","CONTACT","+45 26461897","charlotte.lind@adcendo.com",{"name":171,"role":167,"phone":172,"email":173},"Margaret McNaull","+44 7818457619","margaret.mcnaull@adcendo.com",[],[],[],{"nct_id":4,"conditions":178,"biomarkers":180},[179],"Solid Neoplasm",[]]