[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585137":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":337,"collaborators":339,"id":343,"slug":344,"hasResults":345,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":28,"eligibilityCriteria":349,"healthyVolunteers":345,"sex":350,"minAge":351,"maxAge":352,"enrollmentInfo":353,"targetDuration":28,"studyType":356,"phases":357,"briefSummary":360,"conditions":361,"keywords":364,"overallStatus":47,"whyStopped":28,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":379},{"fullName":5,"class":6},"Nimbus Therapeutics","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A dose escalation","EXPERIMENTAL","Part A Dose Escalation will involve enrolling sequential cohorts with increasing doses of NDI-219216 administered daily in repeating 28-day treatment cycles. The Dose Limiting Toxicity review period for each cohort will be 21 days for each patient enrolled, with review by a Safety Review Committee prior to escalation to the next dose level.",[13],"Drug: NDI-219216",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B Project Optimus","Part B will enroll up to 3 cohorts of patients randomized between up to 3 dose levels determined from Part A Dose Escalation. NDI-219216 will be administered daily in repeating 28-day treatment cycles.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part C Dose Expansion","Part C will enroll 2 groups of patients with dMMR\u002FMSI-h status and other select criteria, utilizing the optimal dose identified from Part B. NDI-219216 will be administered daily in 28-day repeating cycles.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","NDI-219216","NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.",[9,15,19],null,[30],{"name":31,"affiliation":32,"role":33},"Anita Scheuber, MD, PhD","Nimbus Therapeutics, Inc.","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Sean Rossi","CONTACT","857-600-8779","sean.rossi@nimbustx.com",{"name":41,"role":37,"phone":42,"phoneExt":28,"email":43},"Katie Ard, MSN","303-646-7297","katie.ard@nimbustx.com",[45,63,76,89,100,113,124,137,150,163,176,188,203,216,231,245,257,271,285,299,311,325],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"USC Norris Comprehensive Cancer Center","RECRUITING","Los Angeles","California","90089","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-118.24368,34.05223,{"lat":57,"lon":56},[60],{"name":61,"role":62,"phone":28,"phoneExt":28,"email":28},"Josef Lenz, MD; FACP","PRINCIPAL_INVESTIGATOR",{"facility":64,"status":47,"city":65,"state":66,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"University of Chicago Medicine","Chicago","Illinois","60637",{"type":54,"coordinates":69},[70,71],-87.65005,41.85003,{"lat":71,"lon":70},[74],{"name":75,"role":62,"phone":28,"phoneExt":28,"email":28},"John Moroney, MD",{"facility":77,"status":47,"city":78,"state":79,"zip":80,"country":51,"countryCode":52,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University of Louisville James Graham Brown Cancer Center","Louisville","Kentucky","40202",{"type":54,"coordinates":82},[83,84],-85.75941,38.25424,{"lat":84,"lon":83},[87],{"name":88,"role":62,"phone":28,"phoneExt":28,"email":28},"Rebecca Redman, MD",{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":51,"countryCode":52,"cosmosGeoPoint":95,"geoPoint":99,"contacts":28},"Cayuga Cancer Center","TERMINATED","Ithaca","New York","14850",{"type":54,"coordinates":96},[97,98],-76.49661,42.44063,{"lat":98,"lon":97},{"facility":101,"status":47,"city":102,"state":103,"zip":104,"country":51,"countryCode":52,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Levine Cancer Center","Charlotte","North Carolina","28204",{"type":54,"coordinates":106},[107,108],-80.84313,35.22709,{"lat":108,"lon":107},[111],{"name":112,"role":62,"phone":28,"phoneExt":28,"email":28},"R. Wendel Naumann, MD",{"facility":114,"status":47,"city":115,"state":103,"zip":116,"country":51,"countryCode":52,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Atrium Health Wake Forest Baptist Center","Winston-Salem","27157",{"type":54,"coordinates":118},[119,120],-80.24422,36.09986,{"lat":120,"lon":119},[123],{"name":112,"role":62,"phone":28,"phoneExt":28,"email":28},{"facility":125,"status":47,"city":126,"state":127,"zip":128,"country":51,"countryCode":52,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Taylor Cancer Research Center","Maumee","Ohio","43537",{"type":54,"coordinates":130},[131,132],-83.65382,41.56283,{"lat":132,"lon":131},[135],{"name":136,"role":62,"phone":28,"phoneExt":28,"email":28},"John Nemunaitis, MD",{"facility":138,"status":47,"city":139,"state":140,"zip":141,"country":51,"countryCode":52,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Brown University Health","Providence","Rhode Island","02901",{"type":54,"coordinates":143},[144,145],-71.41283,41.82399,{"lat":145,"lon":144},[148],{"name":149,"role":62,"phone":28,"phoneExt":28,"email":28},"Benedito Carneiro Filho, MD; MS; PhD",{"facility":151,"status":47,"city":152,"state":153,"zip":154,"country":51,"countryCode":52,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Prisma Health Cancer Institute - Multidisciplinary Center","Greenville","South Carolina","29605",{"type":54,"coordinates":156},[157,158],-82.39401,34.85262,{"lat":158,"lon":157},[161],{"name":162,"role":62,"phone":28,"phoneExt":28,"email":28},"William Edenfield, MD",{"facility":164,"status":47,"city":165,"state":166,"zip":167,"country":51,"countryCode":52,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"University of Virginia Emily Couric Clinical Cancer Center","Charlottesville","Virginia","22908",{"type":54,"coordinates":169},[170,171],-78.47668,38.02931,{"lat":171,"lon":170},[174],{"name":175,"role":62,"phone":28,"phoneExt":28,"email":28},"Matthew Reilley, MD",{"facility":177,"status":47,"city":178,"state":166,"zip":179,"country":51,"countryCode":52,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Virginia Cancer Specialists, P.C. - Fairfax","Fairfax","22031",{"type":54,"coordinates":181},[182,183],-77.30637,38.84622,{"lat":183,"lon":182},[186],{"name":187,"role":62,"phone":28,"phoneExt":28,"email":28},"Alexander Spira, MD;PhD;FACP",{"facility":189,"status":47,"city":190,"state":191,"zip":192,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Liverpool Hospital","Liverpool","New South Wales","2170","Australia","AU",{"type":54,"coordinates":196},[197,198],150.92588,-33.91938,{"lat":198,"lon":197},[201],{"name":202,"role":62,"phone":28,"phoneExt":28,"email":28},"Aflah Roohullah, MD; PHD",{"facility":204,"status":47,"city":205,"state":206,"zip":207,"country":193,"countryCode":194,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Southern Oncology Clinical Research Unit","Bedford Park","South Australia","5042",{"type":54,"coordinates":209},[210,211],138.56815,-35.02204,{"lat":211,"lon":210},[214],{"name":215,"role":62,"phone":28,"phoneExt":28,"email":28},"Ganessan Kichenadasse, MD; PHD",{"facility":217,"status":47,"city":218,"state":219,"zip":220,"country":221,"countryCode":222,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Princess Margaret Cancer Center","Toronto","Ontario","M5G2C4","Canada","CA",{"type":54,"coordinates":224},[225,226],-79.39864,43.70643,{"lat":226,"lon":225},[229],{"name":230,"role":62,"phone":28,"phoneExt":28,"email":28},"Eric Chen, MD; PHD",{"facility":232,"status":47,"city":233,"state":28,"zip":234,"country":235,"countryCode":236,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP)","Paris","75012","France","FR",{"type":54,"coordinates":238},[239,240],2.3488,48.85341,{"lat":240,"lon":239},[243],{"name":244,"role":62,"phone":28,"phoneExt":28,"email":28},"Thierry Andre, MD",{"facility":246,"status":47,"city":247,"state":28,"zip":248,"country":235,"countryCode":236,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Centre Hospitalier Universitaire (CHU) de Poitiers","Poitiers","86021",{"type":54,"coordinates":250},[251,252],0.34348,46.58261,{"lat":252,"lon":251},[255],{"name":256,"role":62,"phone":28,"phoneExt":28,"email":28},"David Tougeron, MD",{"facility":258,"status":47,"city":259,"state":28,"zip":260,"country":261,"countryCode":262,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"START Dublin","Dublin","D07 R2WY","Ireland","IE",{"type":54,"coordinates":264},[265,266],-6.24889,53.33306,{"lat":266,"lon":265},[269],{"name":270,"role":62,"phone":28,"phoneExt":28,"email":28},"Austin Duffy, MD",{"facility":272,"status":47,"city":273,"state":28,"zip":274,"country":275,"countryCode":276,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"START Lisbon","Lisbon","1649-028","Portugal","PT",{"type":54,"coordinates":278},[279,280],-9.1498,38.72509,{"lat":280,"lon":279},[283],{"name":284,"role":62,"phone":28,"phoneExt":28,"email":28},"Andre Mansinho, MD",{"facility":286,"status":47,"city":287,"state":28,"zip":288,"country":289,"countryCode":290,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"START Barcelona","Barcelona","08023","Spain","ES",{"type":54,"coordinates":292},[293,294],2.15899,41.38879,{"lat":294,"lon":293},[297],{"name":298,"role":62,"phone":28,"phoneExt":28,"email":28},"Roberto Martin Huertas, MD",{"facility":300,"status":47,"city":301,"state":28,"zip":302,"country":289,"countryCode":290,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"Hospital Clinico San Carlos","Madrid","28040",{"type":54,"coordinates":304},[305,306],-3.70256,40.4165,{"lat":306,"lon":305},[309],{"name":310,"role":62,"phone":28,"phoneExt":28,"email":28},"Jorge Bartolome, MD",{"facility":312,"status":47,"city":313,"state":28,"zip":314,"country":315,"countryCode":316,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"Sarah Cannon Research Institute UK","London","W1G 6AD","United Kingdom","UK",{"type":54,"coordinates":318},[319,320],-0.12574,51.50853,{"lat":320,"lon":319},[323],{"name":324,"role":62,"phone":28,"phoneExt":28,"email":28},"Elisa Fontana, MD",{"facility":326,"status":47,"city":327,"state":28,"zip":328,"country":315,"countryCode":316,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"The Christie NHS Foundation Trust UK","Manchester","M20 4BX",{"type":54,"coordinates":330},[331,332],-2.23743,53.48095,{"lat":332,"lon":331},[335],{"name":336,"role":62,"phone":28,"phoneExt":28,"email":28},"Donna Graham, MD",{"type":338,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[340],{"name":341,"class":342},"Worldwide Clinical Trials","OTHER","100585137","phase-1-a-study-to-assess-the-safety-tolerability-and-efficacy-of-ndi-219216-in-patients-with-advanced-solid-tumors-100585137",false,"NCT06898450","A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 in Patients With Advanced Solid Tumors With\u002FWithout Microsatellite Instability and\u002For Deficient Mismatch Repair","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Have unresectable and\u002For metastatic solid tumors (with or without MSI-H\u002FdMMR) refractory to or intolerant to previous SoC therapy or for which no SoC therapy exists\n* Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation)\n* Adequate bone marrow \u002F hematologic, end-organ, and cardiovascular function\n* Resolution of all acute (or toxic) adverse effects of prior therapies, radiation therapy, or surgical procedures to Grade ≤ 1 (except fatigue, alopecia, and peripheral neuropathy).\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular disease.\n* Patients with known WRN syndrome.\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.","ALL","18 Years","99 Years",{"count":354,"type":355},134,"ESTIMATED","INTERVENTIONAL",[358,359],"PHASE1","PHASE2","The goal of this clinical trial is to learn if NDI-219216 is safe for patients, and if NDI-219216 might be a possible treatment for advanced solid tumors in the later phases of the study.\n\nThe main questions it aims to answer are:\n\nIs NDI-219216 safe and what kinds of side effects might it cause? What kind of effects does NDI-219216 have on the body? Does NDI-219216 have any impact on tumor size?\n\nParticipants will:\n\nTake NDI-219216 every day by mouth. Visit the clinic 6 times during Cycle 1, 2 times during Cycle 2, once a month thereafter for checkups and tests while on the study, then one time for an end of treatment visit. After the End of Study, a follow up will occur but can be done on the phone.\n\nKeep a diary of their tablet consumption and symptoms experienced.",[362,363],"Advanced Solid Tumors Cancer","MSI-H Cancer",[365,366,367,368],"Advanced Solid Tumors","Microsatellite Instability","Deficient Mismatch Repair","Werner syndrome helicase","2026-05-04",{"date":371,"type":372},"2026-05-06","ACTUAL",{"date":374,"type":372},"2025-03-31",{"date":376,"type":355},"2031-12",{"name":378,"class":6},"Nimbus Wadjet, Inc.",22]