[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540334":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":211,"collaborators":24,"id":213,"slug":24,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":24,"eligibilityCriteria":218,"healthyVolunteers":214,"sex":219,"minAge":220,"maxAge":24,"enrollmentInfo":221,"targetDuration":24,"studyType":224,"phases":225,"briefSummary":227,"conditions":228,"keywords":24,"overallStatus":165,"whyStopped":24,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},{"fullName":5,"class":6},"Cybrexa Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CBX-12 - 125mg\u002Fm2 q21d","EXPERIMENTAL","125mg\u002Fm2 CBX-12 administered by intravenous (IV) infusion every 21 days. Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity.",[13],"Drug: CBX-12",{"label":15,"type":10,"description":16,"interventionNames":17},"CBX-12 - 100mg\u002Fm2 q21d","100mg\u002Fm2 CBX-12 administered by intravenous (IV) infusion every 21 days. Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","CBX-12","CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Michael Needle, MD","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Clinical Operations Trial Team","CONTACT","860-717-2731","clinicalstudies@cybrexa.com",[36,49,59,69,79,89,98,108,118,128,137,143,153,163,178,192,201],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":24},"Honor Health","WITHDRAWN","Scottsdale","Arizona","85260","United States",{"type":44,"coordinates":45},"Point",[46,47],-111.89903,33.50921,{"lat":47,"lon":46},{"facility":50,"status":51,"city":52,"state":40,"zip":53,"country":42,"cosmosGeoPoint":54,"geoPoint":58,"contacts":24},"Arizona Oncology Associates","ACTIVE_NOT_RECRUITING","Tucson","85711",{"type":44,"coordinates":55},[56,57],-110.92648,32.22174,{"lat":57,"lon":56},{"facility":60,"status":51,"city":61,"state":62,"zip":63,"country":42,"cosmosGeoPoint":64,"geoPoint":68,"contacts":24},"Usc Norris Comprehensive Cancer Center","Los Angeles","California","90033",{"type":44,"coordinates":65},[66,67],-118.24368,34.05223,{"lat":67,"lon":66},{"facility":70,"status":51,"city":71,"state":72,"zip":73,"country":42,"cosmosGeoPoint":74,"geoPoint":78,"contacts":24},"Yale University School of Medicine","New 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Medical","10021",{"type":44,"coordinates":141},[134,135],{"lat":135,"lon":134},{"facility":144,"status":51,"city":145,"state":146,"zip":147,"country":42,"cosmosGeoPoint":148,"geoPoint":152,"contacts":24},"University Hospitals Seidman Cancer Center","Cleveland","Ohio","44106",{"type":44,"coordinates":149},[150,151],-81.69541,41.4995,{"lat":151,"lon":150},{"facility":154,"status":51,"city":155,"state":156,"zip":157,"country":42,"cosmosGeoPoint":158,"geoPoint":162,"contacts":24},"Oncology Associates of Oregon","Eugene","Oregon","97401",{"type":44,"coordinates":159},[160,161],-123.08675,44.05207,{"lat":161,"lon":160},{"facility":164,"status":165,"city":166,"state":167,"zip":168,"country":42,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Allegheny Singer Research Institute D\u002FB\u002FA Ahn Research Institution","RECRUITING","Pittsburgh","Pennsylvania","15212",{"type":44,"coordinates":170},[171,172],-79.99589,40.44062,{"lat":172,"lon":171},[175],{"name":176,"role":32,"phone":177,"phoneExt":24,"email":24},"Shannon Buono","412-578-4216",{"facility":179,"status":165,"city":180,"state":181,"zip":182,"country":42,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Mary Crowley Cancer Research","Dallas","Texas","75251",{"type":44,"coordinates":184},[185,186],-96.80667,32.78306,{"lat":186,"lon":185},[189],{"name":190,"role":32,"phone":191,"phoneExt":24,"email":24},"Cristina Laviada","972-566-3044",{"facility":193,"status":51,"city":194,"state":181,"zip":195,"country":42,"cosmosGeoPoint":196,"geoPoint":200,"contacts":24},"Texas Oncology- Gulf Coast","The Woodlands","77380",{"type":44,"coordinates":197},[198,199],-95.48938,30.15799,{"lat":199,"lon":198},{"facility":202,"status":51,"city":203,"state":204,"zip":205,"country":42,"cosmosGeoPoint":206,"geoPoint":210,"contacts":24},"Multicare Institute For Research & Innovation","Tacoma","Washington","98405",{"type":44,"coordinates":207},[208,209],-122.44429,47.25288,{"lat":209,"lon":208},{"type":212,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100540334",false,"NCT06315491","A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer","A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer","Inclusion Criteria:\n\n* Subjects must have histologically- or cytologically-diagnosed epithelial high-grade serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that is refractory to prior therapy and must have platinum-resistant disease defined as:\n\n  * Subjects who have received only 1 platinum-based chemotherapy regimen for at least 4 cycles of platinum must have disease progression on treatment or occurring ≤ 26 weeks after their last dose of platinum.\n  * Patients who have progressed following a second course of a platinum based regimen.\n  * Subjects may have up to 2 additional systemic regimens for advanced or metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or bevacizumab) are not considered separate regimens.\n* Age greater than or equal to 18 years at the time of signing the informed consent form (ICF).\n* Has measurable disease per RECIST 1.1.\n* Has provided written informed consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate liver, renal, hematologic, pulmonary and coagulation function.\n\nExclusion Criteria:\n\n* Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-12.\n* Subjects who are currently receiving any other anticancer or investigational agent(s).\n* Clinically significant intercurrent disease.\n* Active human immunodeficiency virus (HIV) infection.\n* Active hepatitis B or C infection.","FEMALE","18 Years",{"count":222,"type":223},40,"ESTIMATED","INTERVENTIONAL",[226],"PHASE2","The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg\u002Fm2 every 21 days or 100 mg\u002Fm2 every 21 days.",[229,230],"Platinum-resistant Ovarian Cancer","Refractory Ovarian Carcinoma","2025-10-02",{"date":233,"type":234},"2025-10-06","ACTUAL",{"date":236,"type":234},"2024-09-25",{"date":238,"type":223},"2025-10",{"name":5,"class":6},17]