[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613133":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":138,"collaborators":140,"id":143,"slug":29,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":29,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":29,"enrollmentInfo":151,"targetDuration":29,"studyType":154,"phases":155,"briefSummary":158,"conditions":159,"keywords":167,"overallStatus":74,"whyStopped":29,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Eikon Therapeutics","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1A (Dose escalation, Monotherapy)","EXPERIMENTAL","EIK1005 will be given as monotherapy in participants without alternative treatment options.",[13],"Drug: EIK1005",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1B (Dose escalation, Combination with pembrolizumab)","EIK1005 will be given in combination with pembrolizumab to participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) solid tumors.",[13,18],"Drug: pembrolizumab (KEYTRUDA® )",{"label":20,"type":10,"description":21,"interventionNames":22},"Part 2 (Dose optimization, Monotherapy)","Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) advanced solid tumors will be randomized to receive EIK1005 monotherapy at one of the two identified doses selected from Part 1A.",[13],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","EIK1005","EIK1005 is a selective inhibitor of the Werner helicase.",[9,15,20],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"pembrolizumab (KEYTRUDA® )","Pembrolizumab is a PD-1 inhibitor.",[15],[35],{"name":36,"affiliation":37,"role":38},"Nilou Mobashery, MD","Eikon Therapeutics, Inc.","STUDY_DIRECTOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":29,"email":44},"Ana C Mamede, PharmD","CONTACT","347-806-4584","mamedea@eikontx.com",{"name":46,"role":42,"phone":29,"phoneExt":29,"email":47},"Krishna Kaza","kazak@eikontx.com",[49,63,72,83,89,97,106,114,123,128],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":29},"Morristown Medical Center","NOT_YET_RECRUITING","Morristown","New Jersey","07960","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-74.48154,40.79677,{"lat":61,"lon":60},{"facility":64,"status":51,"city":65,"state":65,"zip":66,"country":55,"countryCode":56,"cosmosGeoPoint":67,"geoPoint":71,"contacts":29},"Memorial Sloan Kettering Cancer Center (MSKCC)","New York","10022",{"type":58,"coordinates":68},[69,70],-74.00597,40.71427,{"lat":70,"lon":69},{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":55,"countryCode":56,"cosmosGeoPoint":78,"geoPoint":82,"contacts":29},"University of Texas MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030",{"type":58,"coordinates":79},[80,81],-95.36327,29.76328,{"lat":81,"lon":80},{"facility":84,"status":51,"city":85,"state":86,"zip":29,"country":87,"countryCode":88,"cosmosGeoPoint":29,"geoPoint":29,"contacts":29},"GenesisCare North Shore (Oncology)","Saint Leonards","New South Wales","Australia","AU",{"facility":90,"status":74,"city":91,"state":86,"zip":29,"country":87,"countryCode":88,"cosmosGeoPoint":92,"geoPoint":96,"contacts":29},"Calvary Mater Newcastle Hospital","Waratah",{"type":58,"coordinates":93},[94,95],151.72647,-32.90667,{"lat":95,"lon":94},{"facility":98,"status":74,"city":99,"state":100,"zip":29,"country":87,"countryCode":88,"cosmosGeoPoint":101,"geoPoint":105,"contacts":29},"Grampians Health","Ballarat","Victoria",{"type":58,"coordinates":102},[103,104],143.84957,-37.56622,{"lat":104,"lon":103},{"facility":107,"status":74,"city":108,"state":100,"zip":29,"country":87,"countryCode":88,"cosmosGeoPoint":109,"geoPoint":113,"contacts":29},"Chris O'Brien Lifehouse (Sydney Cancer Centre)","Camperdown",{"type":58,"coordinates":110},[111,112],143.14983,-38.23392,{"lat":112,"lon":111},{"facility":115,"status":51,"city":116,"state":100,"zip":117,"country":87,"countryCode":88,"cosmosGeoPoint":118,"geoPoint":122,"contacts":29},"Oncology Clinics Victoria (OCV) - Cabrini Brighton Hospital","Frankston","3199",{"type":58,"coordinates":119},[120,121],145.12291,-38.14458,{"lat":121,"lon":120},{"facility":124,"status":74,"city":116,"state":100,"zip":29,"country":87,"countryCode":88,"cosmosGeoPoint":125,"geoPoint":127,"contacts":29},"Peninsula and Southeast Oncology (PASO) Medical",{"type":58,"coordinates":126},[120,121],{"lat":121,"lon":120},{"facility":129,"status":74,"city":130,"state":29,"zip":29,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":29},"Health New Zealand","Wellington","New Zealand","NZ",{"type":58,"coordinates":134},[135,136],174.77557,-41.28664,{"lat":136,"lon":135},{"type":139,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[141],{"name":142,"class":6},"Merck Sharp & Dohme LLC","100613133",false,"NCT07262619","EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors","A Multicenter, Multi-Part, Phase 1\u002F2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors","Key Inclusion Criteria:\n\n1. is ≥ 18 years of age at the time of signing the informed consent.\n2. has a life expectancy of at least 3 months.\n3. has histologically or cytologically documented advanced (unresectable and\u002For metastatic) solid tumor. Part 1A: recommend that participants have archival tissue not more than 3 years old. Part 1B and Part 2: participant has locally confirmed Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) tumor. Participant must have archival tumor tissue (not more than 3 years old) for retrospective confirmation of MSI-H or dMMR tumor by a central laboratory.\n4. In Part 1A, has received and then progressed after or is intolerant to at least 1 standard treatment regimen in the advanced setting. The participant does not have alternative therapeutic options per PI's medical judgement. Preference should be given to: (1) participants with MSI-H or dMMR cancers that have progressed after checkpoint inhibitor (CPI) therapy and (2) participants with microsatellite stable cells (MSS) cancers that have progressed following at least one regimen of platinum, alkylating or topoisomerase containing chemotherapy.\n5. has measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the PI.\n6. has an Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.\n7. has an adequate organ and marrow function.\n\nKey Exclusion Criteria:\n\n1. has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy-induced adverse events (AEs).\n2. has received prior treatment with Werner (WRN) inhibitor.\n3. has a history of relevant drug hypersensitivity, ascertained or presumptive allergy\u002Fhypersensitivity to the active drug substance and\u002For formulation ingredients, history of serious allergic reactions leading to hospitalization, or any other allergic reaction in general.\n4. In Parts 1B and Part 2 Rescue: diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n5. has known additional malignancy that is progressing or has required active treatment within the past 3 years.\n6. has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study treatment.\n7. has mean resting QTcF \\> 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs).\n8. has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Participants may enroll with the following conditions: Type 1 diabetes, hypothyroidism requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia not requiring systemic treatment).\n9. has history of (non-infectious) pneumonitis\u002Fpneumonitis\u002Finterstitial lung disease that required steroids or current pneumonitis\u002Finterstitial lung disease.\n10. has active tuberculosis.\n11. has any active infections requiring systemic therapy.","ALL","18 Years",{"count":152,"type":153},160,"ESTIMATED","INTERVENTIONAL",[156,157],"PHASE1","PHASE2","The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.",[160,161,162,163,164,165,166],"Advanced Solid Tumors","MSI-H or dMMR Advanced Solid Tumors","MSI-H\u002FdMMR Gastric Cancer","MSI-H\u002FdMMR Colorectal Cancer","MSI-H\u002FdMMR Gastroesophageal-junction Cancer","Endometrial Cancer","Mismatch Repair Deficient or MSI-High Solid Tumors",[168,169,170,171,172,26,160,173,174,175,176,177,178],"Werner helicase","WRN","MSI-H","dMMR","DNA mismatch repair","Metastatic","MSI-H\u002FdMMR Endometrial Cancer","MSI-H\u002FdMMR Prostate Cancer","Pembrolizumab","Mismatch Repair Deficient (dMMR)","Microsatellite Instability High (MSI-H)","2026-04-06",{"date":181,"type":182},"2026-04-08","ACTUAL",{"date":184,"type":182},"2026-01-20",{"date":186,"type":153},"2029-03",{"name":5,"class":6},10]