[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585137":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":329,"collaborators":331,"id":335,"slug":28,"hasResults":336,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":28,"eligibilityCriteria":340,"healthyVolunteers":336,"sex":341,"minAge":342,"maxAge":343,"enrollmentInfo":344,"targetDuration":28,"studyType":347,"phases":348,"briefSummary":351,"conditions":352,"keywords":355,"overallStatus":47,"whyStopped":28,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":370},{"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",[45,62,75,88,99,112,123,136,149,162,175,187,201,214,228,241,253,266,279,292,304,317],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"USC Norris Comprehensive Cancer Center","RECRUITING","Los Angeles","California","90089","United States",{"type":53,"coordinates":54},"Point",[55,56],-118.24368,34.05223,{"lat":56,"lon":55},[59],{"name":60,"role":61,"phone":28,"phoneExt":28,"email":28},"Josef Lenz, MD; FACP","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":47,"city":64,"state":65,"zip":66,"country":51,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"University of Chicago Medicine","Chicago","Illinois","60637",{"type":53,"coordinates":68},[69,70],-87.65005,41.85003,{"lat":70,"lon":69},[73],{"name":74,"role":61,"phone":28,"phoneExt":28,"email":28},"John Moroney, MD",{"facility":76,"status":47,"city":77,"state":78,"zip":79,"country":51,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"University of Louisville James Graham Brown Cancer Center","Louisville","Kentucky","40202",{"type":53,"coordinates":81},[82,83],-85.75941,38.25424,{"lat":83,"lon":82},[86],{"name":87,"role":61,"phone":28,"phoneExt":28,"email":28},"Rebecca Redman, MD",{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":51,"cosmosGeoPoint":94,"geoPoint":98,"contacts":28},"Cayuga Cancer Center","TERMINATED","Ithaca","New York","14850",{"type":53,"coordinates":95},[96,97],-76.49661,42.44063,{"lat":97,"lon":96},{"facility":100,"status":47,"city":101,"state":102,"zip":103,"country":51,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Levine Cancer Center","Charlotte","North Carolina","28204",{"type":53,"coordinates":105},[106,107],-80.84313,35.22709,{"lat":107,"lon":106},[110],{"name":111,"role":61,"phone":28,"phoneExt":28,"email":28},"R. Wendel Naumann, MD",{"facility":113,"status":47,"city":114,"state":102,"zip":115,"country":51,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Atrium Health Wake Forest Baptist Center","Winston-Salem","27157",{"type":53,"coordinates":117},[118,119],-80.24422,36.09986,{"lat":119,"lon":118},[122],{"name":111,"role":61,"phone":28,"phoneExt":28,"email":28},{"facility":124,"status":47,"city":125,"state":126,"zip":127,"country":51,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Taylor Cancer Research Center","Maumee","Ohio","43537",{"type":53,"coordinates":129},[130,131],-83.65382,41.56283,{"lat":131,"lon":130},[134],{"name":135,"role":61,"phone":28,"phoneExt":28,"email":28},"John Nemunaitis, MD",{"facility":137,"status":47,"city":138,"state":139,"zip":140,"country":51,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Brown University Health","Providence","Rhode Island","02901",{"type":53,"coordinates":142},[143,144],-71.41283,41.82399,{"lat":144,"lon":143},[147],{"name":148,"role":61,"phone":28,"phoneExt":28,"email":28},"Benedito Carneiro Filho, MD; MS; PhD",{"facility":150,"status":47,"city":151,"state":152,"zip":153,"country":51,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Prisma Health Cancer Institute - Multidisciplinary Center","Greenville","South Carolina","29605",{"type":53,"coordinates":155},[156,157],-82.39401,34.85262,{"lat":157,"lon":156},[160],{"name":161,"role":61,"phone":28,"phoneExt":28,"email":28},"William Edenfield, MD",{"facility":163,"status":47,"city":164,"state":165,"zip":166,"country":51,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"University of Virginia Emily Couric Clinical Cancer Center","Charlottesville","Virginia","22908",{"type":53,"coordinates":168},[169,170],-78.47668,38.02931,{"lat":170,"lon":169},[173],{"name":174,"role":61,"phone":28,"phoneExt":28,"email":28},"Matthew Reilley, MD",{"facility":176,"status":47,"city":177,"state":165,"zip":178,"country":51,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Virginia Cancer Specialists, P.C. - Fairfax","Fairfax","22031",{"type":53,"coordinates":180},[181,182],-77.30637,38.84622,{"lat":182,"lon":181},[185],{"name":186,"role":61,"phone":28,"phoneExt":28,"email":28},"Alexander Spira, MD;PhD;FACP",{"facility":188,"status":47,"city":189,"state":190,"zip":191,"country":192,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Liverpool Hospital","Liverpool","New South Wales","2170","Australia",{"type":53,"coordinates":194},[195,196],150.92588,-33.91938,{"lat":196,"lon":195},[199],{"name":200,"role":61,"phone":28,"phoneExt":28,"email":28},"Aflah Roohullah, MD; PHD",{"facility":202,"status":47,"city":203,"state":204,"zip":205,"country":192,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Southern Oncology Clinical Research Unit","Bedford Park","South Australia","5042",{"type":53,"coordinates":207},[208,209],138.56815,-35.02204,{"lat":209,"lon":208},[212],{"name":213,"role":61,"phone":28,"phoneExt":28,"email":28},"Ganessan Kichenadasse, MD; PHD",{"facility":215,"status":47,"city":216,"state":217,"zip":218,"country":219,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Princess Margaret Cancer Center","Toronto","Ontario","M5G2C4","Canada",{"type":53,"coordinates":221},[222,223],-79.39864,43.70643,{"lat":223,"lon":222},[226],{"name":227,"role":61,"phone":28,"phoneExt":28,"email":28},"Eric Chen, MD; PHD",{"facility":229,"status":47,"city":230,"state":28,"zip":231,"country":232,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP)","Paris","75012","France",{"type":53,"coordinates":234},[235,236],2.3488,48.85341,{"lat":236,"lon":235},[239],{"name":240,"role":61,"phone":28,"phoneExt":28,"email":28},"Thierry Andre, MD",{"facility":242,"status":47,"city":243,"state":28,"zip":244,"country":232,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Centre Hospitalier Universitaire (CHU) de Poitiers","Poitiers","86021",{"type":53,"coordinates":246},[247,248],0.34348,46.58261,{"lat":248,"lon":247},[251],{"name":252,"role":61,"phone":28,"phoneExt":28,"email":28},"David Tougeron, MD",{"facility":254,"status":47,"city":255,"state":28,"zip":256,"country":257,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"START Dublin","Dublin","D07 R2WY","Ireland",{"type":53,"coordinates":259},[260,261],-6.24889,53.33306,{"lat":261,"lon":260},[264],{"name":265,"role":61,"phone":28,"phoneExt":28,"email":28},"Austin Duffy, MD",{"facility":267,"status":47,"city":268,"state":28,"zip":269,"country":270,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"START Lisbon","Lisbon","1649-028","Portugal",{"type":53,"coordinates":272},[273,274],-9.1498,38.72509,{"lat":274,"lon":273},[277],{"name":278,"role":61,"phone":28,"phoneExt":28,"email":28},"Andre Mansinho, MD",{"facility":280,"status":47,"city":281,"state":28,"zip":282,"country":283,"cosmosGeoPoint":284,"geoPoint":288,"contacts":289},"START Barcelona","Barcelona","08023","Spain",{"type":53,"coordinates":285},[286,287],2.15899,41.38879,{"lat":287,"lon":286},[290],{"name":291,"role":61,"phone":28,"phoneExt":28,"email":28},"Roberto Martin Huertas, MD",{"facility":293,"status":47,"city":294,"state":28,"zip":295,"country":283,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"Hospital Clinico San Carlos","Madrid","28040",{"type":53,"coordinates":297},[298,299],-3.70256,40.4165,{"lat":299,"lon":298},[302],{"name":303,"role":61,"phone":28,"phoneExt":28,"email":28},"Jorge Bartolome, MD",{"facility":305,"status":47,"city":306,"state":28,"zip":307,"country":308,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Sarah Cannon Research Institute UK","London","W1G 6AD","United Kingdom",{"type":53,"coordinates":310},[311,312],-0.12574,51.50853,{"lat":312,"lon":311},[315],{"name":316,"role":61,"phone":28,"phoneExt":28,"email":28},"Elisa Fontana, MD",{"facility":318,"status":47,"city":319,"state":28,"zip":320,"country":308,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"The Christie NHS Foundation Trust UK","Manchester","M20 4BX",{"type":53,"coordinates":322},[323,324],-2.23743,53.48095,{"lat":324,"lon":323},[327],{"name":328,"role":61,"phone":28,"phoneExt":28,"email":28},"Donna Graham, MD",{"type":330,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[332],{"name":333,"class":334},"Worldwide Clinical Trials","OTHER","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":345,"type":346},134,"ESTIMATED","INTERVENTIONAL",[349,350],"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.",[353,354],"Advanced Solid Tumors Cancer","MSI-H Cancer",[356,357,358,359],"Advanced Solid Tumors","Microsatellite Instability","Deficient Mismatch Repair","Werner syndrome helicase","2026-05-04",{"date":362,"type":363},"2026-05-06","ACTUAL",{"date":365,"type":363},"2025-03-31",{"date":367,"type":346},"2031-12",{"name":369,"class":6},"Nimbus Wadjet, Inc.",22]