[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577497":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":120,"collaborators":16,"id":122,"slug":16,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":16,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":16,"enrollmentInfo":130,"targetDuration":16,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":143,"overallStatus":38,"whyStopped":16,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Accent Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Subjects will be enrolled at various doses and\u002For schedules of ATX-295 to identify the expansion dose(s) and RP2D",[13],"Drug: ATX-295",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion: Platinum-Resistant, -Refractory, or -Intolerant HGSOC",null,[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":16},"DRUG","ATX-295","ATX-295 Tablets will be taken orally",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Gozde Colak, PhD","339-707-5855","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":16,"email":34},"Priya Rajaratnam","CONTACT","339) 970-7383","clinicaltrials@accenttx.com",[36,56,71,87,103],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Florida Cancer Specialists","RECRUITING","Sarasota","Florida","34232","United States",{"type":44,"coordinates":45},"Point",[46,47],-82.53065,27.33643,{"lat":47,"lon":46},[50,53],{"name":51,"role":32,"phone":52,"phoneExt":16,"email":16},"Latisha Hall","941-377-9993",{"name":54,"role":55,"phone":16,"phoneExt":16,"email":16},"Judy Wang, MD","PRINCIPAL_INVESTIGATOR",{"facility":57,"status":38,"city":58,"state":59,"zip":60,"country":42,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":44,"coordinates":62},[63,64],-86.78444,36.16589,{"lat":64,"lon":63},[67,69],{"name":51,"role":32,"phone":68,"phoneExt":16,"email":16},"615-329-7640",{"name":70,"role":55,"phone":16,"phoneExt":16,"email":16},"Deepak Bhamidipati, MD",{"facility":72,"status":38,"city":73,"state":74,"zip":75,"country":42,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":44,"coordinates":77},[78,79],-95.36327,29.76328,{"lat":79,"lon":78},[82,86],{"name":83,"role":32,"phone":84,"phoneExt":16,"email":85},"Timothy Yap, MD, PhD","713-563-1784","tyap@mdanderson.org",{"name":83,"role":55,"phone":16,"phoneExt":16,"email":16},{"facility":88,"status":38,"city":89,"state":74,"zip":90,"country":42,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"NEXT Oncology","San Antonio","78229",{"type":44,"coordinates":92},[93,94],-98.49363,29.42412,{"lat":94,"lon":93},[97,101],{"name":98,"role":32,"phone":99,"phoneExt":16,"email":100},"Jordan Georg","210-580-5921","jgeorg@nextoncology.com",{"name":102,"role":55,"phone":16,"phoneExt":16,"email":16},"Ildefonso Ismael Rodriguez Rivera, MD",{"facility":104,"status":38,"city":105,"state":106,"zip":107,"country":42,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"NEXT Virginia","Fairfax","Virginia","22031",{"type":44,"coordinates":109},[110,111],-77.30637,38.84622,{"lat":111,"lon":110},[114,118],{"name":115,"role":32,"phone":116,"phoneExt":16,"email":117},"Maybelle De La Rosa","703-783-4518","mdelarosa@nextoncology.com",{"name":119,"role":55,"phone":16,"phoneExt":16,"email":16},"Alexander Spira, MD, PhD, FACP",{"type":121,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100577497",false,"NCT06799065","First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer","A Phase 1\u002F2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer","Key Inclusion Criteria:\n\n* Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC\n* Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit\n* For the expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant\n* There is no limit to the number of prior treatment regimens\n* Have measurable or evaluable disease\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nKey Exclusion Criteria:\n\n* Clinically unstable central nervous system (CNS) tumors or brain metastasis\n* Any other concurrent anti-cancer treatment, except for hormonal blockade\n* Has undergone a major surgery within 3 weeks of starting study treatment\n* Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial\n* Clinically significant (ie, active) or uncontrolled cardiovascular disease\n* Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study.\n* Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers\n* Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment\n\nOther inclusion and exclusion criteria as defined in the study protocol","ALL","18 Years",{"count":131,"type":132},90,"ESTIMATED","INTERVENTIONAL",[135],"PHASE1","The goal of this study is to identify a safe and tolerated dose of the orally administered KIF18A inhibitor ATX-295. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ATX-295 in patients with advanced solid tumors and ovarian cancer.",[138,139,140,141,142],"Advanced Solid Tumors","Breast Cancer Recurrent","Ovarian Cancer","High-grade Serous Ovarian Carcinoma","Triple Negative Breast Cancer",[144,145,146,147,148,149],"KIF","KIF18A","HGSOC","Platinum-resistant","Platinum-intolerant","Platinum-refractory","2026-02-21",{"date":152,"type":153},"2026-02-24","ACTUAL",{"date":155,"type":153},"2025-03-21",{"date":157,"type":132},"2027-08-30",{"name":5,"class":6},5]