[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100428178":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":45,"responsibleParty":258,"collaborators":30,"id":260,"slug":261,"hasResults":262,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":262,"sex":268,"minAge":269,"maxAge":30,"enrollmentInfo":270,"targetDuration":30,"studyType":273,"phases":274,"briefSummary":276,"conditions":277,"keywords":30,"overallStatus":62,"whyStopped":30,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},{"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",[46,60,70,80,90,100,110,120,130,140,148,154,164,174,179,189,199,209,221,227,237,247],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":30},"# 1019, UCLA, Westwood Cancer Center","COMPLETED","Los Angeles","California","90095","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-118.24368,34.05223,{"lat":58,"lon":57},{"facility":61,"status":62,"city":63,"state":50,"zip":64,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":30},"#1025, University of California San Francisco","RECRUITING","San Francisco","94158",{"type":55,"coordinates":66},[67,68],-122.41942,37.77493,{"lat":68,"lon":67},{"facility":71,"status":62,"city":72,"state":73,"zip":74,"country":52,"countryCode":53,"cosmosGeoPoint":75,"geoPoint":79,"contacts":30},"#1012, Yale","New Haven","Connecticut","06520",{"type":55,"coordinates":76},[77,78],-72.92816,41.30815,{"lat":78,"lon":77},{"facility":81,"status":62,"city":82,"state":83,"zip":84,"country":52,"countryCode":53,"cosmosGeoPoint":85,"geoPoint":89,"contacts":30},"#1017, Mayo Clinic","Jacksonville","Florida","32224",{"type":55,"coordinates":86},[87,88],-81.65565,30.33218,{"lat":88,"lon":87},{"facility":91,"status":62,"city":92,"state":93,"zip":94,"country":52,"countryCode":53,"cosmosGeoPoint":95,"geoPoint":99,"contacts":30},"#1002, Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"type":55,"coordinates":96},[97,98],-71.05977,42.35843,{"lat":98,"lon":97},{"facility":101,"status":62,"city":102,"state":103,"zip":104,"country":52,"countryCode":53,"cosmosGeoPoint":105,"geoPoint":109,"contacts":30},"#1023, START Midwest","Grand Rapids","Michigan","49503",{"type":55,"coordinates":106},[107,108],-85.66809,42.96336,{"lat":108,"lon":107},{"facility":111,"status":62,"city":112,"state":113,"zip":114,"country":52,"countryCode":53,"cosmosGeoPoint":115,"geoPoint":119,"contacts":30},"#1016, Mayo Clinic","Rochester","Minnesota","55902",{"type":55,"coordinates":116},[117,118],-92.4699,44.02163,{"lat":118,"lon":117},{"facility":121,"status":62,"city":122,"state":123,"zip":124,"country":52,"countryCode":53,"cosmosGeoPoint":125,"geoPoint":129,"contacts":30},"#1011, Washington University","St Louis","Missouri","63130",{"type":55,"coordinates":126},[127,128],-90.19789,38.62727,{"lat":128,"lon":127},{"facility":131,"status":62,"city":132,"state":133,"zip":134,"country":52,"countryCode":53,"cosmosGeoPoint":135,"geoPoint":139,"contacts":30},"#1032, Northwell Health Cancer Institute","New Hyde Park","New York","11042",{"type":55,"coordinates":136},[137,138],-73.68791,40.7351,{"lat":138,"lon":137},{"facility":141,"status":48,"city":133,"state":133,"zip":142,"country":52,"countryCode":53,"cosmosGeoPoint":143,"geoPoint":147,"contacts":30},"#1008, Columbia University","10032",{"type":55,"coordinates":144},[145,146],-74.00597,40.71427,{"lat":146,"lon":145},{"facility":149,"status":62,"city":133,"state":133,"zip":150,"country":52,"countryCode":53,"cosmosGeoPoint":151,"geoPoint":153,"contacts":30},"#1004, Memorial Sloan Kettering Cancer Institute","10065",{"type":55,"coordinates":152},[145,146],{"lat":146,"lon":145},{"facility":155,"status":48,"city":156,"state":157,"zip":158,"country":52,"countryCode":53,"cosmosGeoPoint":159,"geoPoint":163,"contacts":30},"#1010, University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":55,"coordinates":160},[161,162],-75.16362,39.95238,{"lat":162,"lon":161},{"facility":165,"status":62,"city":166,"state":167,"zip":168,"country":52,"countryCode":53,"cosmosGeoPoint":169,"geoPoint":173,"contacts":30},"#1007, Rhode Island Hospital","Providence","Rhode Island","02903",{"type":55,"coordinates":170},[171,172],-71.41283,41.82399,{"lat":172,"lon":171},{"facility":175,"status":62,"city":166,"state":167,"zip":168,"country":52,"countryCode":53,"cosmosGeoPoint":176,"geoPoint":178,"contacts":30},"#1030, Women & Infants Hospital of Rhode Island",{"type":55,"coordinates":177},[171,172],{"lat":172,"lon":171},{"facility":180,"status":62,"city":181,"state":182,"zip":183,"country":52,"countryCode":53,"cosmosGeoPoint":184,"geoPoint":188,"contacts":30},"#1001, The University of Texas M.D. Anderson Cancer Center","Houston","Texas","77030",{"type":55,"coordinates":185},[186,187],-95.36327,29.76328,{"lat":187,"lon":186},{"facility":190,"status":62,"city":191,"state":192,"zip":193,"country":52,"countryCode":53,"cosmosGeoPoint":194,"geoPoint":198,"contacts":30},"#1013, The University of Utah","Salt Lake City","Utah","84112",{"type":55,"coordinates":195},[196,197],-111.89105,40.76078,{"lat":197,"lon":196},{"facility":200,"status":62,"city":201,"state":202,"zip":203,"country":52,"countryCode":53,"cosmosGeoPoint":204,"geoPoint":208,"contacts":30},"#1027, University of Virginia","Charlottesville","Virginia","22903",{"type":55,"coordinates":205},[206,207],-78.47668,38.02931,{"lat":207,"lon":206},{"facility":210,"status":48,"city":211,"state":212,"zip":213,"country":214,"countryCode":215,"cosmosGeoPoint":216,"geoPoint":220,"contacts":30},"#2002, The Hospital for Sick Children","Toronto","Ontario","M5G 1X8","Canada","CA",{"type":55,"coordinates":217},[218,219],-79.39864,43.70643,{"lat":219,"lon":218},{"facility":222,"status":62,"city":211,"state":212,"zip":223,"country":214,"countryCode":215,"cosmosGeoPoint":224,"geoPoint":226,"contacts":30},"#2001, Princess Margaret Cancer Centre","M5G 2C1",{"type":55,"coordinates":225},[218,219],{"lat":219,"lon":218},{"facility":228,"status":48,"city":229,"state":230,"zip":231,"country":214,"countryCode":215,"cosmosGeoPoint":232,"geoPoint":236,"contacts":30},"#2003, The Research Institute of the McGill University Health Centre","Montreal","Quebec","H4A 3J1",{"type":55,"coordinates":233},[234,235],-73.58781,45.50884,{"lat":235,"lon":234},{"facility":238,"status":62,"city":239,"state":30,"zip":30,"country":240,"countryCode":241,"cosmosGeoPoint":242,"geoPoint":246,"contacts":30},"#4001, Rigshospitalet - Blegdamsvej","Copenhagen","Denmark","DK",{"type":55,"coordinates":243},[244,245],12.56553,55.67594,{"lat":245,"lon":244},{"facility":248,"status":62,"city":249,"state":30,"zip":250,"country":251,"countryCode":252,"cosmosGeoPoint":253,"geoPoint":257,"contacts":30},"#3003, Sarah Cannon Research Institute","London","W1G 6AD","United Kingdom","UK",{"type":55,"coordinates":254},[255,256],-0.12574,51.50853,{"lat":256,"lon":255},{"type":259,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100428178","phase-1-study-of-lunresertib-alone-or-in-combination-with-rp-3500-or-debio-0123-in-patients-with-advanced-solid-tumors-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":271,"type":272},464,"ESTIMATED","INTERVENTIONAL",[275],"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.",[278],"Advanced Solid Tumor","2026-06-22",{"date":281,"type":282},"2026-06-23","ACTUAL",{"date":284,"type":282},"2021-04-30",{"date":286,"type":272},"2028-06",{"name":5,"class":6},22]