[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522576":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":11,"armGroups":43,"interventions":62,"overallOfficials":11,"centralContacts":68,"locations":73,"responsibleParty":206,"collaborators":11,"id":208,"slug":209,"hasResults":210,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":11,"eligibilityCriteria":214,"healthyVolunteers":210,"sex":215,"minAge":216,"maxAge":11,"enrollmentInfo":217,"targetDuration":11,"studyType":220,"phases":221,"briefSummary":223,"conditions":224,"keywords":229,"overallStatus":76,"whyStopped":11,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},{"fullName":5,"class":6},"Volastra Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":11},[9,13,15,17,19,21],{"measure":10,"description":11,"timeFrame":12},"Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib",null,"Up to 24 months",{"measure":14,"description":11,"timeFrame":12},"Frequency and duration of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0",{"measure":16,"description":11,"timeFrame":12},"Frequency and duration of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0",{"measure":18,"description":11,"timeFrame":12},"Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0",{"measure":20,"description":11,"timeFrame":12},"Frequency of Dose Interruptions and Permanent Treatment Discontinuations",{"measure":22,"description":11,"timeFrame":12},"Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1",[24,26,28,30,32,34],{"measure":25,"description":11,"timeFrame":12},"Duration of Response (DOR) as assessed by RECIST version 1.1",{"measure":27,"description":11,"timeFrame":12},"Disease Control Rate (DCR) as assessed by RECIST version 1.1",{"measure":29,"description":11,"timeFrame":12},"Progression Free Survival (PFS) as assessed by RECIST version 1.1",{"measure":31,"description":11,"timeFrame":12},"Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria",{"measure":33,"description":11,"timeFrame":12},"Overall Survival (OS) (Part 2 only)",{"measure":35,"description":11,"timeFrame":12},"Plasma level of Sovilnesib",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":11,"whoMasked":11},"NONE","This is a phase 1b study of sovilnesib in subjects with advanced solid tumors. The focus of the proposed clinical study is to establish the optimal dose of sovilnesib for further clinical development.\n\nAn adaptive multi-cohort design will be used to assess the safety, tolerability, PK, and efficacy of multiple dose levels in parallel to establish the RP2D of sovilnesib.\n\nThe study will be conducted in two parts: Part 1 and Part 2. Part 1 is a randomized dose optimization phase in the biomarker-unselected platinum resistant HGSOC patient population. Part 2 is a randomized dose optimization phase in the p16 positive (biomarker-selected) platinum resistant HGSOC patient population. Depending on the emerging data of the Part 1 dose optimization stage, consideration will be given to initiate sub-study cohort(s) in other selected locally advanced or metastatic tumor types to provide additional safety, PK\u002FPD and preliminary efficacy data. Early stopping rules for safety based on a Bayesian Toxicity Monitoring Design and for futility based on a Bayesian Efficacy Monitoring via Predictive Probability Design will be applied.\n\nSovilnesib will be given orally in 28-day cycles at selected dose levels of interest. Dosing will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.",[44,50,54,58],{"label":45,"type":46,"description":47,"interventionNames":48},"Dose Level 1","EXPERIMENTAL","Subjects will receive sovilnesib once daily at Dose Level 1 in 28-day cycles.",[49],"Drug: Sovilnesib",{"label":51,"type":46,"description":52,"interventionNames":53},"Dose Level 2","Subjects will receive sovilnesib once daily at Dose Level 2 in 28-day cycles.",[49],{"label":55,"type":46,"description":56,"interventionNames":57},"Dose Level 3","Subjects will receive sovilnesib once daily at Dose Level 3 in 28-day cycles.",[49],{"label":59,"type":46,"description":60,"interventionNames":61},"Dose Level 4","Subjects will receive sovilnesib once daily at Dose Level 4 in 28-day cycles.",[49],[63],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":11},"DRUG","Sovilnesib","Sovilnesib tablets will be given orally.",[45,51,55,59],[69],{"name":5,"role":70,"phone":71,"phoneExt":11,"email":72},"CONTACT","(646) 344-1248","clinicaltrials@volastratx.com",[74,92,103,113,128,138,148,163,171,186,196],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"The University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-86.80249,33.52066,{"lat":86,"lon":85},[89],{"name":90,"role":70,"phone":91,"phoneExt":11,"email":11},"Charles A. Leath, III, MD","205-934-4986",{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":80,"countryCode":81,"cosmosGeoPoint":98,"geoPoint":102,"contacts":11},"University of Arkansas for Medical Sciences","ACTIVE_NOT_RECRUITING","Little Rock","Arkansas","72205",{"type":83,"coordinates":99},[100,101],-92.28959,34.74648,{"lat":101,"lon":100},{"facility":104,"status":94,"city":105,"state":106,"zip":107,"country":80,"countryCode":81,"cosmosGeoPoint":108,"geoPoint":112,"contacts":11},"Hoag Memorial Hospital","Newport Beach","California","92663",{"type":83,"coordinates":109},[110,111],-117.92895,33.61891,{"lat":111,"lon":110},{"facility":114,"status":76,"city":115,"state":116,"zip":117,"country":80,"countryCode":81,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Georgia Cancer Center Augusta University","Atlanta","Georgia","30912",{"type":83,"coordinates":119},[120,121],-84.38798,33.749,{"lat":121,"lon":120},[124],{"name":125,"role":70,"phone":126,"phoneExt":11,"email":127},"Gwendolyn Stanley, RN","706-721-3473","gstanley@augusta.edu",{"facility":129,"status":94,"city":130,"state":131,"zip":132,"country":80,"countryCode":81,"cosmosGeoPoint":133,"geoPoint":137,"contacts":11},"Johns Hopkins Hospital","Baltimore","Maryland","21287",{"type":83,"coordinates":134},[135,136],-76.61219,39.29038,{"lat":136,"lon":135},{"facility":139,"status":94,"city":140,"state":141,"zip":142,"country":80,"countryCode":81,"cosmosGeoPoint":143,"geoPoint":147,"contacts":11},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"type":83,"coordinates":144},[145,146],-71.05977,42.35843,{"lat":146,"lon":145},{"facility":149,"status":76,"city":150,"state":151,"zip":152,"country":80,"countryCode":81,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14263",{"type":83,"coordinates":154},[155,156],-78.87837,42.88645,{"lat":156,"lon":155},[159],{"name":160,"role":70,"phone":161,"phoneExt":11,"email":162},"ASK-RPCI","877-245-7724","askroswell@roswellpark.org",{"facility":164,"status":94,"city":151,"state":151,"zip":165,"country":80,"countryCode":81,"cosmosGeoPoint":166,"geoPoint":170,"contacts":11},"Icahn School of Medicine at Mount Sinai","10128",{"type":83,"coordinates":167},[168,169],-74.00597,40.71427,{"lat":169,"lon":168},{"facility":172,"status":76,"city":173,"state":174,"zip":175,"country":80,"countryCode":81,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"OU Health Stephenson Cancer Center","Oklahoma City","Oklahoma","73117",{"type":83,"coordinates":177},[178,179],-97.51643,35.46756,{"lat":179,"lon":178},[182],{"name":183,"role":70,"phone":184,"phoneExt":11,"email":185},"Christine Pappaterra","405-271-8707","christine-pappaterra@ouhsc.edu",{"facility":187,"status":94,"city":188,"state":189,"zip":190,"country":80,"countryCode":81,"cosmosGeoPoint":191,"geoPoint":195,"contacts":11},"MUSC Hollings Cancer Center","Charleston","South Carolina","29020",{"type":83,"coordinates":192},[193,194],-79.93275,32.77632,{"lat":194,"lon":193},{"facility":197,"status":94,"city":198,"state":199,"zip":200,"country":80,"countryCode":81,"cosmosGeoPoint":201,"geoPoint":205,"contacts":11},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":83,"coordinates":202},[203,204],-122.33207,47.60621,{"lat":204,"lon":203},{"type":207,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100522576","phase-1-a-study-of-sovilnesib-in-subjects-with-ovarian-cancer-100522576",false,"NCT06084416","A Study of Sovilnesib in Subjects With Ovarian Cancer","A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Selected Advanced Solid Tumors","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* Histologically confirmed locally advanced, inoperable, or metastatic tumor.\n* High Grade Serous Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer - histologically confirmed; locally advanced, inoperable or metastatic; p16 positive (Part 2 only); platinum resistant (defined as radiographic progression\u002Frecurrence \\\u003C180 days after last dose of ≥ 4 cycles of platinum containing therapy) or refractory; prior bevacizumab treatment, unless ineligible or intolerant; if germline and\u002For somatic BRCA1\u002F2 mutation, previously treated with PARP-inhibitor (unless ineligible or intolerant).\n\nKey Exclusion Criteria:\n\n* Part 1 only: MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype\n* Endometrioid, clear cell, mucinous, sarcomatoid, low-grade\u002Fborderline ovarian tumor or mixed tumors containing any of the above histologies\n* Previously received KIF18A inhibitor\n* Leptomeningeal disease, or new or progressive CNS metastases or spinal cord compression\n* Cardiac parameters: MI, PE, CABG, severe\u002Funstable angina or stroke ≤ 6 months, NYHA Class ≥ II, LVEF \\\u003C 50%\n* Any gastrointestinal condition (e.g. malabsorption syndrome, surgical anastomosis, short bowel syndrome) that might affect the absorption of oral medications including the study drug","ALL","18 Years",{"count":218,"type":219},150,"ESTIMATED","INTERVENTIONAL",[222],"PHASE1","This is a phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of sovilnesib at different dose levels to establish the optimal dose of sovilnesib in subjects with selected advanced solid tumors.",[225,226,227,228],"High Grade Serous Adenocarcinoma of Ovary","Fallopian Tube Cancer","Primary Peritoneal Carcinoma","Chromosomal Instability",[230],"KIF18A Inhibitor","2026-10-06",{"date":233,"type":234},"2026-10-13","ACTUAL",{"date":236,"type":234},"2024-04-04",{"date":238,"type":219},"2027-12",{"name":5,"class":6},11]