[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Volastra Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":55},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100508635",false,"NCT05902988","A Phase I\u002FII Study of VLS-1488 in Subjects With Advanced Cancer","A Phase I\u002FII Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer","Key Inclusion Criteria:\n\n* All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration\n* Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non -Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction, Bladder (transitional cell), Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), Ovarian Carcinosarcoma, CN-high Endometrial\u002FUterine\n* Dose Expansion: Must have been previously treated with several lines of standard of care treatment specified in the protocol in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), CN-high Endometrial\u002FUterine\n\nKey Exclusion Criteria:\n\n* MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype\n* Previously received KIF18A inhibitor\n* Current CNS metastases or leptomeningeal disease\n* Cardiac parameters: MI or stroke ≤ 1 year, unstable angina\u002FPE\u002FDVT\u002FCABG ≤ 6 months, NYHA Class ≥ II, LVEF \\\u003C 50%\n* Inability to comply with concomitant medication restrictions with respect to strong inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1 (P-gp) and BCRP\n* Any clinically significant ascites or pleural effusions at time of enrollment, or any therapeutic paracentesis or thoracentesis within 28 days of planned first dose of study drug\n* Bowel obstruction or GI perforation within 6 months of planned first dose of study drug","ALL","18 Years",{"count":18,"type":19},200,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","This is a first-in-human phase I\u002FII study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers.",[26,27,28,29,30,31,32,33,34,35],"Advanced Solid Tumor","High Grade Serous Adenocarcinoma of Ovary","Squamous Non-small-cell Lung Cancer","Triple Negative Breast Cancer","Head and Neck Squamous Cell Carcinoma","Ovarian Carcinosarcoma","Uterine Carcinosarcoma","Uterine Serous Carcinoma","Endometrium Cancer","Chromosomal Instability",[37,38,39,40,41],"KIF18A Inhibitor","HGSOC","TNBC","HNSCC","sqNSCLC","RECRUITING","2025-10-31",{"date":45,"type":46},"2025-11-04","ACTUAL",{"date":48,"type":46},"2023-10-18",{"date":50,"type":19},"2026-12",{"name":52,"class":53},"Volastra Therapeutics, Inc.","INDUSTRY",14,""]