[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Adcytherix SAS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"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":19,"type":20},290,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Advanced Malignancy","Advanced Solid Cancers","Metastatic Solid Tumors",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"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","RECRUITING","2026-06-05",{"date":49,"type":50},"2026-06-08","ACTUAL",{"date":52,"type":50},"2026-02-23",{"date":54,"type":20},"2029-11-30",{"name":56,"class":57},"Adcytherix SAS","INDUSTRY",9,""]