[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nimbus Wadjet, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},134,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29],"Advanced Solid Tumors Cancer","MSI-H Cancer",[31,32,33,34],"Advanced Solid Tumors","Microsatellite Instability","Deficient Mismatch Repair","Werner syndrome helicase","RECRUITING","2026-05-04",{"date":38,"type":39},"2026-05-06","ACTUAL",{"date":41,"type":39},"2025-03-31",{"date":43,"type":21},"2031-12",{"name":45,"class":46},"Nimbus Wadjet, Inc.","INDUSTRY",22,""]