[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sqnsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sqnsclc":32},{"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":25,"conditions":26,"keywords":34,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"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, as Monotherapy and in Combination With Anticancer Therapy 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, as Monotherapy and in Combination With Anticancer Therapy 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 monotherapy expansion cohorts:\n* Participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, or platinum-intolerant\n* Participants with sqNSCLC should have received prior treatment with a platinum, taxane, and checkpoint inhibitor\n* For the combination with bevacizumab (or biosimilar): Participants must have histologically confirmed HGSOC or select solid tumors\n* There is no limit to the number of prior treatment regimens\n* Have measurable disease; evaluable disease is acceptable during dose escalation\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},218,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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 as a monotherapy and in combination with bevacizumab (or a biosimilar) in patients with locally advanced or metastatic solid tumors, including ovarian cancer and lung cancer.",[27,28,29,30,31,32,33],"Advanced Solid Tumors","Breast Cancer Recurrent","Ovarian Cancer","High-grade Serous Ovarian Carcinoma","Triple Negative Breast Cancer","sqNSCLC","Squamous Non-small-cell Lung Cancer",[35,36,37,38,39,40,32],"KIF","KIF18A","HGSOC","Platinum-resistant","Platinum-intolerant","Platinum-refractory","RECRUITING","2026-10-11",{"date":44,"type":45},"2026-10-13","ACTUAL",{"date":47,"type":45},"2025-03-21",{"date":49,"type":20},"2027-08-30",{"name":51,"class":52},"Accent Therapeutics","INDUSTRY",11]