[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100428178":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":45,"responsibleParty":254,"collaborators":30,"id":256,"slug":30,"hasResults":257,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":257,"sex":263,"minAge":264,"maxAge":30,"enrollmentInfo":265,"targetDuration":30,"studyType":268,"phases":269,"briefSummary":271,"conditions":272,"keywords":30,"overallStatus":61,"whyStopped":30,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},{"fullName":5,"class":6},"Debiopharm International SA","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1: Lunresertib Single-Agent, Dose Escalation and Food-effect Study","EXPERIMENTAL","Patients receive lunresertib orally until disease progression, unacceptable toxicity, or investigator\u002Fpatient decision. Dose escalation will proceed until a maximum tolerated dose is identified.",[13],"Drug: Lunresertib",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1: Lunresertib in combination with RP-3500, Dose Escalation Study","Patients receive lunresertib with RP-3500 orally until disease progression, unacceptable toxicity, or investigator\u002Fpatient decision. Dose escalation will proceed until a maximum tolerated dose is identified.",[13,18],"Drug: RP-3500",{"label":20,"type":10,"description":21,"interventionNames":22},"Phase 1: Lunresertib in combination with Debio 0123, Dose Escalation Study","Patients receive lunresertib with Debio 0123 orally until disease progression, unacceptable toxicity, or investigator\u002Fpatient decision. Dose escalation will proceed until a maximum tolerated dose is identified.",[13,23],"Drug: Debio0123",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Lunresertib","Oral PKMYT1 Inhibitor",[9,20,15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"RP-3500","Oral ATR Inhibitor",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Debio0123","Oral WEE1 Inhibitor",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Debiopharm International S.A","CONTACT","+41 21 321 01 11","clinicaltrials@debiopharm.com",[46,59,69,79,89,99,109,119,129,139,147,153,163,173,178,188,198,208,219,225,235,244],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":30},"# 1019, UCLA, Westwood Cancer Center","COMPLETED","Los Angeles","California","90095","United States",{"type":54,"coordinates":55},"Point",[56,57],-118.24368,34.05223,{"lat":57,"lon":56},{"facility":60,"status":61,"city":62,"state":50,"zip":63,"country":52,"cosmosGeoPoint":64,"geoPoint":68,"contacts":30},"#1025, University of California San Francisco","RECRUITING","San Francisco","94158",{"type":54,"coordinates":65},[66,67],-122.41942,37.77493,{"lat":67,"lon":66},{"facility":70,"status":61,"city":71,"state":72,"zip":73,"country":52,"cosmosGeoPoint":74,"geoPoint":78,"contacts":30},"#1012, Yale","New Haven","Connecticut","06520",{"type":54,"coordinates":75},[76,77],-72.92816,41.30815,{"lat":77,"lon":76},{"facility":80,"status":61,"city":81,"state":82,"zip":83,"country":52,"cosmosGeoPoint":84,"geoPoint":88,"contacts":30},"#1017, Mayo Clinic","Jacksonville","Florida","32224",{"type":54,"coordinates":85},[86,87],-81.65565,30.33218,{"lat":87,"lon":86},{"facility":90,"status":61,"city":91,"state":92,"zip":93,"country":52,"cosmosGeoPoint":94,"geoPoint":98,"contacts":30},"#1002, Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"type":54,"coordinates":95},[96,97],-71.05977,42.35843,{"lat":97,"lon":96},{"facility":100,"status":61,"city":101,"state":102,"zip":103,"country":52,"cosmosGeoPoint":104,"geoPoint":108,"contacts":30},"#1023, START Midwest","Grand Rapids","Michigan","49503",{"type":54,"coordinates":105},[106,107],-85.66809,42.96336,{"lat":107,"lon":106},{"facility":110,"status":61,"city":111,"state":112,"zip":113,"country":52,"cosmosGeoPoint":114,"geoPoint":118,"contacts":30},"#1016, Mayo Clinic","Rochester","Minnesota","55902",{"type":54,"coordinates":115},[116,117],-92.4699,44.02163,{"lat":117,"lon":116},{"facility":120,"status":61,"city":121,"state":122,"zip":123,"country":52,"cosmosGeoPoint":124,"geoPoint":128,"contacts":30},"#1011, Washington University","St Louis","Missouri","63130",{"type":54,"coordinates":125},[126,127],-90.19789,38.62727,{"lat":127,"lon":126},{"facility":130,"status":61,"city":131,"state":132,"zip":133,"country":52,"cosmosGeoPoint":134,"geoPoint":138,"contacts":30},"#1032, Northwell Health Cancer Institute","New Hyde Park","New York","11042",{"type":54,"coordinates":135},[136,137],-73.68791,40.7351,{"lat":137,"lon":136},{"facility":140,"status":48,"city":132,"state":132,"zip":141,"country":52,"cosmosGeoPoint":142,"geoPoint":146,"contacts":30},"#1008, Columbia University","10032",{"type":54,"coordinates":143},[144,145],-74.00597,40.71427,{"lat":145,"lon":144},{"facility":148,"status":61,"city":132,"state":132,"zip":149,"country":52,"cosmosGeoPoint":150,"geoPoint":152,"contacts":30},"#1004, Memorial Sloan Kettering Cancer Institute","10065",{"type":54,"coordinates":151},[144,145],{"lat":145,"lon":144},{"facility":154,"status":48,"city":155,"state":156,"zip":157,"country":52,"cosmosGeoPoint":158,"geoPoint":162,"contacts":30},"#1010, University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":54,"coordinates":159},[160,161],-75.16362,39.95238,{"lat":161,"lon":160},{"facility":164,"status":61,"city":165,"state":166,"zip":167,"country":52,"cosmosGeoPoint":168,"geoPoint":172,"contacts":30},"#1007, Rhode Island Hospital","Providence","Rhode Island","02903",{"type":54,"coordinates":169},[170,171],-71.41283,41.82399,{"lat":171,"lon":170},{"facility":174,"status":61,"city":165,"state":166,"zip":167,"country":52,"cosmosGeoPoint":175,"geoPoint":177,"contacts":30},"#1030, Women & Infants Hospital of Rhode Island",{"type":54,"coordinates":176},[170,171],{"lat":171,"lon":170},{"facility":179,"status":61,"city":180,"state":181,"zip":182,"country":52,"cosmosGeoPoint":183,"geoPoint":187,"contacts":30},"#1001, The University of Texas M.D. Anderson Cancer Center","Houston","Texas","77030",{"type":54,"coordinates":184},[185,186],-95.36327,29.76328,{"lat":186,"lon":185},{"facility":189,"status":61,"city":190,"state":191,"zip":192,"country":52,"cosmosGeoPoint":193,"geoPoint":197,"contacts":30},"#1013, The University of Utah","Salt Lake City","Utah","84112",{"type":54,"coordinates":194},[195,196],-111.89105,40.76078,{"lat":196,"lon":195},{"facility":199,"status":61,"city":200,"state":201,"zip":202,"country":52,"cosmosGeoPoint":203,"geoPoint":207,"contacts":30},"#1027, University of Virginia","Charlottesville","Virginia","22903",{"type":54,"coordinates":204},[205,206],-78.47668,38.02931,{"lat":206,"lon":205},{"facility":209,"status":48,"city":210,"state":211,"zip":212,"country":213,"cosmosGeoPoint":214,"geoPoint":218,"contacts":30},"#2002, The Hospital for Sick Children","Toronto","Ontario","M5G 1X8","Canada",{"type":54,"coordinates":215},[216,217],-79.39864,43.70643,{"lat":217,"lon":216},{"facility":220,"status":61,"city":210,"state":211,"zip":221,"country":213,"cosmosGeoPoint":222,"geoPoint":224,"contacts":30},"#2001, Princess Margaret Cancer Centre","M5G 2C1",{"type":54,"coordinates":223},[216,217],{"lat":217,"lon":216},{"facility":226,"status":48,"city":227,"state":228,"zip":229,"country":213,"cosmosGeoPoint":230,"geoPoint":234,"contacts":30},"#2003, The Research Institute of the McGill University Health Centre","Montreal","Quebec","H4A 3J1",{"type":54,"coordinates":231},[232,233],-73.58781,45.50884,{"lat":233,"lon":232},{"facility":236,"status":61,"city":237,"state":30,"zip":30,"country":238,"cosmosGeoPoint":239,"geoPoint":243,"contacts":30},"#4001, Rigshospitalet - Blegdamsvej","Copenhagen","Denmark",{"type":54,"coordinates":240},[241,242],12.56553,55.67594,{"lat":242,"lon":241},{"facility":245,"status":61,"city":246,"state":30,"zip":247,"country":248,"cosmosGeoPoint":249,"geoPoint":253,"contacts":30},"#3003, Sarah Cannon Research Institute","London","W1G 6AD","United Kingdom",{"type":54,"coordinates":250},[251,252],-0.12574,51.50853,{"lat":252,"lon":251},{"type":255,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100428178",false,"NCT04855656","Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors","Phase 1\u002F1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors","MYTHIC","Inclusion Criteria:\n\n* Male or female and ≥12 years-of-age at the time of informed consent.\n* Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients \\>16 years of age.\n* Locally advanced or metastatic resistant or refractory solid tumors.\n* Patients \\\u003C18 years of age must weigh at least 40 kg.\n* Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible\n* Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.\n* CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH\n* FBXW7 deleterious mutations identified by either a tumor or plasma NGS test\n* PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test\n* Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be eligible\n* Ability to swallow and retain oral medications.\n* Acceptable hematologic and organ function at screening.\n* Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.\n* Resolution of all toxicities of prior therapy or surgical procedures.\n* Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.\n\nExclusion Criteria:\n\n* Chemotherapy or small molecule antineoplastic agent given within 21 days or \\\u003C5 half-lives, whichever is shorter, prior to first dose of study drug.\n* History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.\n* Patients who are pregnant or breastfeeding.\n* Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.\n* Major surgery within 4 weeks prior to first dose of lunresertib.\n* Uncontrolled, symptomatic brain metastases.\n* Uncontrolled hypertension.\n* Certain prior anti-cancer therapy\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol.","ALL","12 Years",{"count":266,"type":267},464,"ESTIMATED","INTERVENTIONAL",[270],"PHASE1","The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.",[273],"Advanced Solid Tumor","2026-06-22",{"date":276,"type":277},"2026-06-23","ACTUAL",{"date":279,"type":277},"2021-04-30",{"date":281,"type":267},"2028-06",{"name":5,"class":6},22]