[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Accent Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"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":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"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":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30],"Advanced Solid Tumors","Breast Cancer Recurrent","Ovarian Cancer","High-grade Serous Ovarian Carcinoma","Triple Negative Breast Cancer",[32,33,34,35,36,37],"KIF","KIF18A","HGSOC","Platinum-resistant","Platinum-intolerant","Platinum-refractory","RECRUITING","2026-02-21",{"date":41,"type":42},"2026-02-24","ACTUAL",{"date":44,"type":42},"2025-03-21",{"date":46,"type":20},"2027-08-30",{"name":48,"class":49},"Accent Therapeutics","INDUSTRY",5,""]