[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611245":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":120,"collaborators":24,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":24,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":24,"enrollmentInfo":131,"targetDuration":24,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Adcytherix SAS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1a ADCX-020","EXPERIMENTAL","Dose escalation of ADCX-020, intravenous",[13],"Drug: 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FJD","Madrid","28040",{"type":44,"coordinates":110},[111,112],-3.70256,40.4165,{"lat":112,"lon":111},{"facility":115,"status":37,"city":107,"state":107,"zip":116,"country":98,"countryCode":99,"cosmosGeoPoint":117,"geoPoint":119,"contacts":24},"START Madrid CIOCC","28050",{"type":44,"coordinates":118},[111,112],{"lat":112,"lon":111},{"type":121,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100611245","phase-1-adcx-020-for-the-treatment-of-patients-with-locally-advanced-or-metastatic-cancers-100611245",false,"NCT07238075","ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers","A First-in-human, Multicenter Dose Escalation and Multiple Cohort Expansion Phase 1a\u002Fb Study to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ADCX-020 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Male and female participants ≥ 18 years of age\n* Ph1a: Locally advanced or metastatic solid tumor relapsed or PD following local standard treatments, for which no standard treatment is available\n* Ph1b: Eligible patients should have only received prior lines of systemic therapy according to SoC in the advanced\u002Fmetastatic setting (not counting neoadjuvant\u002Fadjuvant treatment if completed \\>6 months prior to recurrence)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Radiologically measurable disease by RECIST v1.1\n* Mandatory adequate tumor tissue sample available\n* Must have recovered from all clinically relevant toxicities from previous cancer therapies (to at least Grade 1, except for alopecia)\n\nExclusion Criteria:\n\n* Known allergies\u002Fhypersensitivity\u002Fintolerance to or contraindication to exatecan, or any excipient\n* Phase 1b: Prior antibody drug conjugate exposure with a topoisomerase 1 inhibitor payload\n* Uncontrolled or significant cardiac disease including left ventricular ejection fraction (LVEF) \\\u003C50%, myocardial infarction or uncontrolled\u002Funstable angina\n* Has clinically active central nervous system (CNS) metastases\n* Has a history of lung fibrosis or non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Active corneal disease, or history of corneal disease within 12 months prior to enrollment\n* Other unacceptable abnormalities, medications or procedures as defined by protocol","ALL","18 Years",{"count":132,"type":133},290,"ESTIMATED","INTERVENTIONAL",[136],"PHASE1","The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors. ADCX-020 is an investigational anticancer therapy called antibody drug conjugate.\n\nThis study is set up in multiple parts. In the first part of the study, participants receive increasing doses of ADCX-020. Then 2 or more doses will be assessed to identify the optimal dose. This optimal dose is subsequently evaluated for effect on different cancer types.",[139,140,141],"Advanced Malignancy","Advanced Solid Cancers","Metastatic Solid Tumors",[143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158],"Antibody Drug Conjugate","Antineoplastic Agents","Monoclonal Antibodies","Neoplasms","Response Evaluation Criteria in Solid Tumors (RECIST)","Phase 1 clinical trial","Maximum Tolerated Dose","Open-Label Trials","Multicenter Study","Pharmacokinetics","Pharmacodynamics","Drug-Related Side Effects and Adverse Reactions","Dose-Response Relationship, Drug","Adults","Progression-Free Survival \u002F Overall Survival","Overall response rate","2026-06-05",{"date":161,"type":162},"2026-06-08","ACTUAL",{"date":164,"type":162},"2026-02-23",{"date":166,"type":133},"2029-11-30",{"name":5,"class":6},9]