[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chromosomal-instability\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chromosomal-instability":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"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":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100508635","phase-1-a-phase-iii-study-of-vls-1488-in-subjects-with-advanced-cancer-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":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27,28,29,30,31,32,33,34,35,36],"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",[38,39,40,41,42],"KIF18A Inhibitor","HGSOC","TNBC","HNSCC","sqNSCLC","RECRUITING","2025-10-31",{"date":46,"type":47},"2025-11-04","ACTUAL",{"date":49,"type":47},"2023-10-18",{"date":51,"type":20},"2026-12",{"name":53,"class":54},"Volastra Therapeutics, Inc.","INDUSTRY",14,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100556176","translational-study-of-mss-tp53-mutation-and-chromosome-instability-relationship-in-endometrial-carcinoma-100556176","NCT06521684","Translational Study of MSS, TP53 Mutation and Chromosome Instability Relationship in Endometrial Carcinoma","Inclusion Criteria:\n\n* willing to participate in the study and sign the informed consent\n* age ≥18 years old\n* researchers evaluated that it was suitable to participate in this translational study\n* Endometrial cancer was confirmed histologically\n* histopathological molecular classification was consistent with pMMR type and POLE wild type\n* The tumor tissue obtained by operation was the primary lesion\n\nExclusion Criteria:\n\n* Received chemotherapy within 14 days prior to sample collection, or received anti-tumor drug therapy such as radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, within 21 days prior to sample collection\n* previously treated with KIF18A inhibitors\n* researchers believed that the subjects were not suitable for the translational study for other reasons","FEMALE",{"count":64,"type":20},110,"OBSERVATIONAL","The objective is to understand the relationship between TP53 mutation, MSS and chromosome instability in endometrial cancer and the effect on clinical prognosis.We will collect a small amount of tumor tissue samples. NGS panel detection and WGD\u002FAS analysis were performed on the tissue. Paracancer tissue was used as a negative control and relevant information in medical records during the operation. Then we will collect clinical diagnosis and disease information through telephone follow-up after the completion of the operation.",[68,69,36,70],"Endometrial Neoplasms","TP53 Gene Mutation","Microsatellite Stable Endometrial Carcinoma",[72,36,73,69,74],"Endometrial Cancer","microsatellite stability","Whole genome duplication","NOT_YET_RECRUITING","2024-07-22",{"date":78,"type":47},"2024-07-26",{"date":80,"type":20},"2024-09-01",{"date":82,"type":20},"2025-06-01",{"name":84,"class":85},"Peking Union Medical College Hospital","OTHER"]