[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577497":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":189,"collaborators":16,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":16,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":199,"maxAge":16,"enrollmentInfo":200,"targetDuration":16,"studyType":203,"phases":204,"briefSummary":206,"conditions":207,"keywords":213,"overallStatus":38,"whyStopped":16,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"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",[36,58,74,91,109,125,140,156,172],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of Colorado Denver","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-104.83192,39.72943,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":16,"email":54},"Michael 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563-1784","tyap@mdanderson.org",{"name":152,"role":57,"phone":16,"phoneExt":16,"email":16},{"facility":157,"status":38,"city":158,"state":143,"zip":159,"country":42,"countryCode":43,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"NEXT Oncology","San Antonio","78229",{"type":45,"coordinates":161},[162,163],-98.49363,29.42412,{"lat":163,"lon":162},[166,170],{"name":167,"role":32,"phone":168,"phoneExt":16,"email":169},"Jordan Georg","210-580-5921","jgeorg@nextoncology.com",{"name":171,"role":57,"phone":16,"phoneExt":16,"email":16},"Ildefonso Ismael Rodriguez Rivera, MD",{"facility":173,"status":38,"city":174,"state":175,"zip":176,"country":42,"countryCode":43,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"NEXT Virginia","Fairfax","Virginia","22031",{"type":45,"coordinates":178},[179,180],-77.30637,38.84622,{"lat":180,"lon":179},[183,187],{"name":184,"role":32,"phone":185,"phoneExt":16,"email":186},"Maybelle De La Rosa","703-783-4518","mdelarosa@nextoncology.com",{"name":188,"role":57,"phone":16,"phoneExt":16,"email":16},"Alexander Spira, MD, PhD, FACP",{"type":190,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100577497","phase-1-first-in-human-study-of-atx-295-an-oral-inhibitor-of-kif18a-in-patients-with-advanced-or-metastatic-solid-tumors-including-ovarian-cancer-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":201,"type":202},90,"ESTIMATED","INTERVENTIONAL",[205],"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.",[208,209,210,211,212],"Advanced Solid Tumors","Breast Cancer Recurrent","Ovarian Cancer","High-grade Serous Ovarian Carcinoma","Triple Negative Breast Cancer",[214,215,216,217,218,219],"KIF","KIF18A","HGSOC","Platinum-resistant","Platinum-intolerant","Platinum-refractory","2026-08-15",{"date":222,"type":223},"2026-08-18","ACTUAL",{"date":225,"type":223},"2025-03-21",{"date":227,"type":202},"2027-08-30",{"name":5,"class":6},9]