[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607819":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":135,"collaborators":31,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":31,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":31,"enrollmentInfo":146,"targetDuration":31,"studyType":149,"phases":150,"briefSummary":153,"conditions":154,"keywords":159,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Avenzo Therapeutics, Inc.","INDUSTRY",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1, monotherapy","EXPERIMENTAL","Part A",[13],"Drug: AVZO-103",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1, combination","Part B",[13,18],"Drug: Combination Agent",{"label":20,"type":10,"description":11,"interventionNames":21},"Phase 2, monotherapy",[13],{"label":23,"type":10,"description":16,"interventionNames":24},"Phase 2, combination",[13,18],[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","AVZO-103","Specific dose in protocol specified schedule",[15,9,23,20],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Combination Agent","Per label based on combination agent used",[15,23],[37],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Medical Information","CONTACT","(858) 239-2944","ClinicalTrials@avenzotx.com",[43,57,66,74,83,91,100,109,118,127],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":31},"Avenzo Therapeutics Recruiting Site","RECRUITING","San Francisco","California","94158","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-122.41942,37.77493,{"lat":55,"lon":54},{"facility":44,"status":45,"city":58,"state":59,"zip":60,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":65,"contacts":31},"Orlando","Florida","32827",{"type":52,"coordinates":62},[63,64],-81.37924,28.53834,{"lat":64,"lon":63},{"facility":44,"status":45,"city":67,"state":59,"zip":68,"country":49,"countryCode":50,"cosmosGeoPoint":69,"geoPoint":73,"contacts":31},"Tampa","33612",{"type":52,"coordinates":70},[71,72],-82.45843,27.94752,{"lat":72,"lon":71},{"facility":44,"status":45,"city":75,"state":76,"zip":77,"country":49,"countryCode":50,"cosmosGeoPoint":78,"geoPoint":82,"contacts":31},"Boston","Massachusetts","02114",{"type":52,"coordinates":79},[80,81],-71.05977,42.35843,{"lat":81,"lon":80},{"facility":44,"status":45,"city":84,"state":84,"zip":85,"country":49,"countryCode":50,"cosmosGeoPoint":86,"geoPoint":90,"contacts":31},"New York","10065",{"type":52,"coordinates":87},[88,89],-74.00597,40.71427,{"lat":89,"lon":88},{"facility":44,"status":45,"city":92,"state":93,"zip":94,"country":49,"countryCode":50,"cosmosGeoPoint":95,"geoPoint":99,"contacts":31},"Chapel Hill","North Carolina","27514",{"type":52,"coordinates":96},[97,98],-79.05584,35.9132,{"lat":98,"lon":97},{"facility":44,"status":45,"city":101,"state":102,"zip":103,"country":49,"countryCode":50,"cosmosGeoPoint":104,"geoPoint":108,"contacts":31},"Myrtle Beach","South Carolina","29572",{"type":52,"coordinates":105},[106,107],-78.88669,33.68906,{"lat":107,"lon":106},{"facility":44,"status":45,"city":110,"state":111,"zip":112,"country":49,"countryCode":50,"cosmosGeoPoint":113,"geoPoint":117,"contacts":31},"Nashville","Tennessee","37203",{"type":52,"coordinates":114},[115,116],-86.78444,36.16589,{"lat":116,"lon":115},{"facility":44,"status":45,"city":119,"state":120,"zip":121,"country":49,"countryCode":50,"cosmosGeoPoint":122,"geoPoint":126,"contacts":31},"Austin","Texas","78758",{"type":52,"coordinates":123},[124,125],-97.74306,30.26715,{"lat":125,"lon":124},{"facility":44,"status":45,"city":128,"state":120,"zip":129,"country":49,"countryCode":50,"cosmosGeoPoint":130,"geoPoint":134,"contacts":31},"Irving","75039",{"type":52,"coordinates":131},[132,133],-96.94889,32.81402,{"lat":133,"lon":132},{"type":136,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100607819","phase-1-beacon-1-study-of-avzo-103-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-avzo-103-1001-100607819",false,"NCT07193511","BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001)","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-103, a Nectin4\u002FTrop2 ADC, as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","Key Inclusion Criteria:\n\n* Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria:\n\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* Prior Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of allogenic stem cell or solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.","ALL","18 Years",{"count":147,"type":148},355,"ESTIMATED","INTERVENTIONAL",[151,152],"PHASE1","PHASE2","This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors.",[155,156,157,158],"Solid Tumor Cancer","Locally Advanced","Metastatic Solid Tumors","Urothelial Cancer",[160,161,156,158],"Solid Tumors","Metastatic","2026-05-21",{"date":164,"type":165},"2026-05-26","ACTUAL",{"date":167,"type":165},"2025-10-02",{"date":169,"type":148},"2030-09",{"name":5,"class":6},10]