[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551688":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":47,"studyPopulation":40,"armGroups":48,"interventions":55,"overallOfficials":61,"centralContacts":66,"locations":72,"responsibleParty":255,"collaborators":40,"id":257,"slug":40,"hasResults":258,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":40,"eligibilityCriteria":262,"healthyVolunteers":258,"sex":263,"minAge":264,"maxAge":40,"enrollmentInfo":265,"targetDuration":40,"studyType":268,"phases":269,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":75,"whyStopped":40,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},{"fullName":5,"class":6},"Schrödinger, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":40},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of adverse events (AEs)","Incidence and severity of adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs); and dose interruptions, dose reductions, dose delays and study drug discontinuation due to AEs.","Day 1 to 28 days after the last dose of SGR-3515.",{"measure":14,"description":14,"timeFrame":15},"Incidence of Dose Limiting Toxicities (DLTs)","Day 1 to Day 28 of the first 28-day dosing cycle.",{"measure":17,"description":17,"timeFrame":18},"Incidence of serious adverse events (SAEs)","Day 1 to 28 days after the last dose of SGR-3515",{"measure":20,"description":20,"timeFrame":21},"Recommended phase 2 dose and schedule","From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.",[23,27,30,33,36],{"measure":24,"description":25,"timeFrame":26},"Pharmacokinetics: Measures Cmax and Cmin of SGR-3515","Pharmacokinetics: Cmax and Cmin of SGR-3515","Day 1 to Day 28 of first 28-day dosing cycle",{"measure":28,"description":29,"timeFrame":26},"Pharmacokinetics Measures: t1\u002F2 of SGR-3515","Pharmacokinetics: t1\u002F2 of SGR-3515",{"measure":31,"description":32,"timeFrame":26},"Pharmacokinetics Measures: tmax of SGR-3515","Pharmacokinetics: tmax of SGR-3515",{"measure":34,"description":35,"timeFrame":26},"Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515","Pharmacokinetics: Area Under the Curve (AUC) of SGR-3515",{"measure":37,"description":38,"timeFrame":39},"Efficacy analysis","Efficacy analysis will be performed for each dose level and include but not limited to objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and duration of disease control (DDC), which will be assessed by investigators","Day 1 to end of Phase I study",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"NA","SINGLE_GROUP","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE","SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of SGR-3515, in participants with advanced solid tumors hypothesized to be sensitive to Wee1\u002FMyt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway, including but not limited to CCNE1 amplification.",[49],{"label":50,"type":51,"description":52,"interventionNames":53},"Dose Escalation","EXPERIMENTAL","28-day treatment cycle.",[54],"Drug: SGR-3515",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":40},"DRUG","SGR-3515","SGR-3515 will be administered orally with an intermittent schedule.",[50],[62],{"name":63,"affiliation":64,"role":65},"Margaret Dugan, MD","CMO\u002FStudy Physician","STUDY_DIRECTOR",[67],{"name":68,"role":69,"phone":70,"phoneExt":40,"email":71},"Study Physician","CONTACT","+15032991150","sdgr-trials-group@schrodinger.com",[73,91,104,117,129,141,154,167,179,192,205,214,227,240],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Yale University, Yale Cancer Center","RECRUITING","New Haven","Connecticut","06520","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-72.92816,41.30815,{"lat":85,"lon":84},[88],{"name":89,"role":90,"phone":40,"phoneExt":40,"email":40},"Patricia LoRusso, DO","PRINCIPAL_INVESTIGATOR",{"facility":92,"status":75,"city":93,"state":94,"zip":95,"country":79,"countryCode":80,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Northwestern University","Chicago","Illinois","60611",{"type":82,"coordinates":97},[98,99],-87.65005,41.85003,{"lat":99,"lon":98},[102],{"name":103,"role":90,"phone":40,"phoneExt":40,"email":40},"Pedro de Viveiros, MD",{"facility":105,"status":75,"city":106,"state":107,"zip":108,"country":79,"countryCode":80,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"University of Michigan","Ann Arbor","Michigan","48109",{"type":82,"coordinates":110},[111,112],-83.74088,42.27756,{"lat":112,"lon":111},[115],{"name":116,"role":90,"phone":40,"phoneExt":40,"email":40},"Jean Siedel, DO",{"facility":118,"status":75,"city":119,"state":107,"zip":120,"country":79,"countryCode":80,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Karmanos Cancer Institute","Detroit","48201",{"type":82,"coordinates":122},[123,124],-83.04575,42.33143,{"lat":124,"lon":123},[127],{"name":128,"role":90,"phone":40,"phoneExt":40,"email":40},"Ira Winer, MD",{"facility":130,"status":75,"city":131,"state":131,"zip":132,"country":79,"countryCode":80,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Icahn School of Medicine at Mount Sinai","New York","10029",{"type":82,"coordinates":134},[135,136],-74.00597,40.71427,{"lat":136,"lon":135},[139],{"name":140,"role":90,"phone":40,"phoneExt":40,"email":40},"Deborah Doroshow, MD",{"facility":142,"status":75,"city":143,"state":144,"zip":145,"country":79,"countryCode":80,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Levine Cancer Institute","Charlotte","North Carolina","28204",{"type":82,"coordinates":147},[148,149],-80.84313,35.22709,{"lat":149,"lon":148},[152],{"name":153,"role":90,"phone":40,"phoneExt":40,"email":40},"Robert W Naumann, MD",{"facility":155,"status":75,"city":156,"state":157,"zip":158,"country":79,"countryCode":80,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"University of Cincinnati Medical Center","Cincinnati","Ohio","45267",{"type":82,"coordinates":160},[161,162],-84.51439,39.12711,{"lat":162,"lon":161},[165],{"name":166,"role":90,"phone":40,"phoneExt":40,"email":40},"Amanda Jackson, MD",{"facility":168,"status":75,"city":169,"state":157,"zip":170,"country":79,"countryCode":80,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Ohio State University","Columbus","43210",{"type":82,"coordinates":172},[173,174],-82.99879,39.96118,{"lat":174,"lon":173},[177],{"name":178,"role":90,"phone":40,"phoneExt":40,"email":40},"John Hays, MD",{"facility":180,"status":75,"city":181,"state":182,"zip":183,"country":79,"countryCode":80,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Stephenson Cancer Center","Oklahoma City","Oklahoma","73104",{"type":82,"coordinates":185},[186,187],-97.51643,35.46756,{"lat":187,"lon":186},[190],{"name":191,"role":90,"phone":40,"phoneExt":40,"email":40},"Kathleen N Moore, MD",{"facility":193,"status":75,"city":194,"state":195,"zip":196,"country":79,"countryCode":80,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"type":82,"coordinates":198},[199,200],-86.78444,36.16589,{"lat":200,"lon":199},[203],{"name":204,"role":90,"phone":40,"phoneExt":40,"email":40},"Vivek Subbiah, MD",{"facility":206,"status":75,"city":194,"state":195,"zip":207,"country":79,"countryCode":80,"cosmosGeoPoint":208,"geoPoint":210,"contacts":211},"Vanderbilt-Ingram Cancer Center\u002FHenry-Joyce Cancer Clinic","37232",{"type":82,"coordinates":209},[199,200],{"lat":200,"lon":199},[212],{"name":213,"role":90,"phone":40,"phoneExt":40,"email":40},"Michael K Gibson, MD",{"facility":215,"status":75,"city":216,"state":217,"zip":218,"country":79,"countryCode":80,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"University of Texas Southwestern","Dallas","Texas","75235",{"type":82,"coordinates":220},[221,222],-96.80667,32.78306,{"lat":222,"lon":221},[225],{"name":226,"role":90,"phone":40,"phoneExt":40,"email":40},"David Miller, MD",{"facility":228,"status":75,"city":229,"state":230,"zip":231,"country":79,"countryCode":80,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"NEXT Virginia","Fairfax","Virginia","22031",{"type":82,"coordinates":233},[234,235],-77.30637,38.84622,{"lat":235,"lon":234},[238],{"name":239,"role":90,"phone":40,"phoneExt":40,"email":40},"Mohamad A Salkeni, MD",{"facility":241,"status":75,"city":242,"state":243,"zip":244,"country":245,"countryCode":246,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Princess Margaret Cancer Centre","Toronto","Ontario","MSG 1X6","Canada","CA",{"type":82,"coordinates":248},[249,250],-79.39864,43.70643,{"lat":250,"lon":249},[253],{"name":254,"role":90,"phone":40,"phoneExt":40,"email":40},"Stephanie Lheureux, MD",{"type":256,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100551688",false,"NCT06463340","Study of SGR-3515 In Participants With Advanced Solid Tumors.","A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor\n* Measurable disease per RECIST version 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments\u002Fprocedures\n* Adequate bone marrow and organ function\n* Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug\n\nExclusion Criteria\n\n* Participants with primary Central Nervous System (CNS tumors).\n* Participant has received prior systemic anti-cancer treatments or other investigational agents ≤ 21 days of first dose of study drug, or 5 half-lives, whichever is shorter\n* Participant who has received definitive local control radiation (any dose greater than 50 Gy) \\\u003C 42 days prior to the first dose of study drug.\n* Participant who has received major surgeries ≤ 21 days prior to first dose of study drug\n* Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.\n* Participant who has another clinically significant invasive malignancy, as determined by the investigator, ≤ 2 years prior to the first dose","ALL","18 Years",{"count":266,"type":267},52,"ESTIMATED","INTERVENTIONAL",[270],"PHASE1","The purpose of this study is to learn about the effects of a new study drug, called SGR-3515 that may be a treatment for advanced solid tumors.",[273],"Advanced Solid Tumor",[275,273],"Solid Tumor","2025-07-29",{"date":278,"type":279},"2025-08-01","ACTUAL",{"date":281,"type":279},"2024-06-18",{"date":283,"type":267},"2026-12-31",{"name":5,"class":6},14]