[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508635":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":38,"responsibleParty":247,"collaborators":32,"id":249,"slug":250,"hasResults":251,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":32,"eligibilityCriteria":255,"healthyVolunteers":251,"sex":256,"minAge":257,"maxAge":32,"enrollmentInfo":258,"targetDuration":32,"studyType":261,"phases":262,"briefSummary":265,"conditions":266,"keywords":277,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},{"fullName":5,"class":6},"Volastra Therapeutics, Inc.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation: Dose Escalation Cohorts","EXPERIMENTAL","Subjects will be enrolled at various doses and\u002For schedules of VLS-1488. These Dose Escalation Cohorts will be utilized to identify the MTD and to select dose levels for Dose Expansion.",[13],"Drug: VLS-1488",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Escalation: Backfill Cohorts","Additional subjects may be enrolled at any dose level that does not meet de-escalation or elimination rules per the BOIN design. These Backfill Cohorts will be utilized to build additional data to support selection of doses and\u002For tumor types for further study in Dose Expansion.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose Expansion: Exploration Cohorts","Subjects with a selected single tumor type will be randomized 1:1 into Exploration Cohorts at two or more dose levels of interest. A subset of subjects will have additional assessments to examine the potential for VLS-1488 to interact with other drugs and the effect of food on VLS-1488 absorption.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Dose Expansion: Development Cohorts","Subjects with other tumor types will be enrolled at a single dose level of interest. These Development Cohorts will be utilized to examine the preliminary efficacy of VLS-1488 in various tumor types.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","VLS-1488","VLS-1488 tablets will be given orally.",[15,9,23,19],null,[34],{"name":5,"role":35,"phone":36,"phoneExt":32,"email":37},"CONTACT","(646) 344-1248","clinicaltrials@volastratx.com",[39,60,74,89,104,119,133,148,163,173,187,202,217,232],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Southern California","RECRUITING","Los Angeles","California","90033","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-118.24368,34.05223,{"lat":51,"lon":50},[54,57],{"name":55,"role":35,"phone":32,"phoneExt":32,"email":56},"Xiomara Menendez, RN","Xiomara.Menendez@med.usc.edu",{"name":58,"role":35,"phone":32,"phoneExt":32,"email":59},"Lorraine Martinez, MD","Lorraine.Martinez@med.usc.edu",{"facility":61,"status":41,"city":62,"state":43,"zip":63,"country":45,"countryCode":46,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Hoag Memorial Hospital","Newport Beach","92663",{"type":48,"coordinates":65},[66,67],-117.92895,33.61891,{"lat":67,"lon":66},[70],{"name":71,"role":35,"phone":72,"phoneExt":32,"email":73},"Patrice Jones","9497645501","patrice.jones@hoag.org",{"facility":75,"status":41,"city":76,"state":77,"zip":78,"country":45,"countryCode":46,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"University of Colorado Cancer Center","Aurora","Colorado","80045",{"type":48,"coordinates":80},[81,82],-104.83192,39.72943,{"lat":82,"lon":81},[85],{"name":86,"role":35,"phone":87,"phoneExt":32,"email":88},"Yasmin Yazdani Farsad","303-724-9403","YASMIN.YAZDANIFARSAD@CUANSCHUTZ.EDU",{"facility":90,"status":41,"city":91,"state":92,"zip":93,"country":45,"countryCode":46,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Yale Cancer Center","New Haven","Connecticut","06511",{"type":48,"coordinates":95},[96,97],-72.92816,41.30815,{"lat":97,"lon":96},[100],{"name":101,"role":35,"phone":102,"phoneExt":32,"email":103},"Ingrid Palma","203-833-1034","ingrid.palma@yale.edu",{"facility":105,"status":41,"city":106,"state":107,"zip":108,"country":45,"countryCode":46,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Kellogg Cancer Center","Evanston","Illinois","60201",{"type":48,"coordinates":110},[111,112],-87.69006,42.04114,{"lat":112,"lon":111},[115],{"name":116,"role":35,"phone":117,"phoneExt":32,"email":118},"Michele Britto","(847) 570-2109","mbritto@northshore.org",{"facility":120,"status":41,"city":121,"state":122,"zip":123,"country":45,"countryCode":46,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Community Health Network","Indianapolis","Indiana","46256",{"type":48,"coordinates":125},[126,127],-86.15804,39.76838,{"lat":127,"lon":126},[130],{"name":131,"role":35,"phone":32,"phoneExt":32,"email":132},"Megan Haas","mhaas2@ecommunity.com",{"facility":134,"status":41,"city":135,"state":136,"zip":137,"country":45,"countryCode":46,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Johns Hopkins Sidney Kimmel Comprehensive Cancer Center","Baltimore","Maryland","21224",{"type":48,"coordinates":139},[140,141],-76.61219,39.29038,{"lat":141,"lon":140},[144],{"name":145,"role":35,"phone":146,"phoneExt":32,"email":147},"Matthew Bark","443-927-8743","Mbark1@jhmi.edu",{"facility":149,"status":41,"city":150,"state":151,"zip":152,"country":45,"countryCode":46,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"University of Michigan","Ann Arbor","Michigan","48109",{"type":48,"coordinates":154},[155,156],-83.74088,42.27756,{"lat":156,"lon":155},[159],{"name":160,"role":35,"phone":161,"phoneExt":32,"email":162},"Cancer AnswerLine","800-865-1125","CancerAnswerLine@med.umich.edu",{"facility":164,"status":165,"city":166,"state":151,"zip":167,"country":45,"countryCode":46,"cosmosGeoPoint":168,"geoPoint":172,"contacts":32},"START Midwest","ACTIVE_NOT_RECRUITING","Grand Rapids","49546",{"type":48,"coordinates":169},[170,171],-85.66809,42.96336,{"lat":171,"lon":170},{"facility":174,"status":41,"city":175,"state":175,"zip":176,"country":45,"countryCode":46,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Memorial Sloan Kettering Cancer Center","New York","10065",{"type":48,"coordinates":178},[179,180],-74.00597,40.71427,{"lat":180,"lon":179},[183],{"name":184,"role":35,"phone":185,"phoneExt":32,"email":186},"Claire Friedman, MD","646-888-4593","friedmac@mskcc.org",{"facility":188,"status":41,"city":189,"state":190,"zip":191,"country":45,"countryCode":46,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"The Christ Hospital","Cincinnati","Ohio","45219",{"type":48,"coordinates":193},[194,195],-84.51439,39.12711,{"lat":195,"lon":194},[198],{"name":199,"role":35,"phone":200,"phoneExt":32,"email":201},"Abby Reed, RN","513-585-1140","abby.reed@thechristhospital.com",{"facility":203,"status":41,"city":204,"state":205,"zip":206,"country":45,"countryCode":46,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Women & Infants Hospital","Providence","Rhode Island","02905",{"type":48,"coordinates":208},[209,210],-71.41283,41.82399,{"lat":210,"lon":209},[213],{"name":214,"role":35,"phone":215,"phoneExt":32,"email":216},"Emma Locke","401-430-8181","oncologyresearch@wihri.org",{"facility":218,"status":41,"city":219,"state":220,"zip":221,"country":45,"countryCode":46,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"M.D. Anderson Cancer Center","Houston","Texas","77030",{"type":48,"coordinates":223},[224,225],-95.36327,29.76328,{"lat":225,"lon":224},[228],{"name":229,"role":35,"phone":230,"phoneExt":32,"email":231},"Ecaterina Dumbrava, MD","713-792-3934","eeileana@mdanderson.org",{"facility":233,"status":41,"city":234,"state":235,"zip":236,"country":45,"countryCode":46,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Froedtert & the Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":48,"coordinates":238},[239,240],-87.90647,43.0389,{"lat":240,"lon":239},[243],{"name":244,"role":35,"phone":245,"phoneExt":32,"email":246},"Clinical Trials Office","414-805-8900","cccto@mcw.edu",{"type":248,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":259,"type":260},200,"ESTIMATED","INTERVENTIONAL",[263,264],"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.",[267,268,269,270,271,272,273,274,275,276],"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",[278,279,280,281,282],"KIF18A Inhibitor","HGSOC","TNBC","HNSCC","sqNSCLC","2025-10-31",{"date":285,"type":286},"2025-11-04","ACTUAL",{"date":288,"type":286},"2023-10-18",{"date":290,"type":260},"2026-12",{"name":5,"class":6},14]