[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550671":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":38,"studyPopulation":30,"armGroups":39,"interventions":45,"overallOfficials":30,"centralContacts":50,"locations":56,"responsibleParty":116,"collaborators":30,"id":118,"slug":30,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":38,"acronym":30,"eligibilityCriteria":122,"healthyVolunteers":119,"sex":123,"minAge":124,"maxAge":30,"enrollmentInfo":125,"targetDuration":30,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":59,"whyStopped":30,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"SURGE Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]","Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment","21 Days",{"measure":14,"description":15,"timeFrame":16},"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0","Time on trial up to 90 days",[18,22,26],{"measure":19,"description":20,"timeFrame":21},"Pharmacokinetics of STM-416p","Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood","Day 0, post 24 hours, post 48 hour",{"measure":23,"description":24,"timeFrame":25},"Pharmacodynamics of STM-416p in blood circulating cytokines","Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level","Day 0, post 24 hours, post 48 hours, post 21 days",{"measure":27,"description":28,"timeFrame":29},"Assess surgical wound healing","Assessment of wound healing scored according to a modified ASEPSIS method","Day 7, Day 21",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"NA","SINGLE_GROUP","Single group assignment","TREATMENT",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE","A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy",[40],{"label":41,"type":42,"description":41,"interventionNames":43},"STM-416p","EXPERIMENTAL",[44],"Drug: STM-416p",[46],{"type":47,"name":41,"description":48,"armGroupLabels":49,"otherNames":30},"DRUG","STM-416p monotherapy",[41],[51],{"name":52,"role":53,"phone":54,"phoneExt":30,"email":55},"Kayti Aviano","CONTACT","781-605-8632","kayti@surgetx.com",[57,78,95,108],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Arizona Urology Specialists","RECRUITING","Tucson","Arizona","85715","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-110.92648,32.22174,{"lat":69,"lon":68},[72,75],{"name":73,"role":53,"phone":30,"phoneExt":30,"email":74},"Jasmine Simpson","JSIMPSON@arizonauro.com",{"name":76,"role":77,"phone":30,"phoneExt":30,"email":30},"Susan Kalota, MD","PRINCIPAL_INVESTIGATOR",{"facility":79,"status":59,"city":80,"state":81,"zip":82,"country":63,"countryCode":64,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"University of Florida","Gainesville","Florida","32608",{"type":66,"coordinates":84},[85,86],-82.32483,29.65163,{"lat":86,"lon":85},[89,91,93],{"name":90,"role":53,"phone":30,"phoneExt":30,"email":30},"Danielle Geckler",{"name":30,"role":53,"phone":30,"phoneExt":30,"email":92},"d.geckler@ufl.edu",{"name":94,"role":77,"phone":30,"phoneExt":30,"email":30},"Paul Crispen, MD",{"facility":96,"status":59,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":30,"geoPoint":30,"contacts":102},"Australian Prostate Center","Melbourne N.","Victoria","3051","Australia","AU",[103,106],{"name":104,"role":53,"phone":30,"phoneExt":30,"email":105},"Dina Bushell","dina.bushell@apcr.org.au",{"name":107,"role":77,"phone":30,"phoneExt":30,"email":30},"Phil Dundee, MD",{"facility":109,"status":59,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":30,"geoPoint":30,"contacts":110},"Epworth HealthCare",[111,114],{"name":112,"role":53,"phone":30,"phoneExt":30,"email":113},"Daniel Shokouhi","ctc-urorenal@epworth.org.au",{"name":115,"role":77,"phone":30,"phoneExt":30,"email":30},"Nathan Lawrentschuk, Prof",{"type":117,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100550671",false,"NCT06450106","Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy","Inclusion Criteria:\n\n1. Males aged 18 years or older at time of informed consent.\n2. Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.\n3. Grade Group 2-5.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.\n5. Have adequate organ and bone marrow function at screening.\n6. Able to understand and be willing to sign an Institutional Review Board\u002FEthics Committee-approved written informed consent document\n\nExclusion Criteria:\n\n1. Have an invasive malignancy, other than the disease under study.\n2. Anticipated to require the use of a drain after radical prostatectomy.\n3. Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy ) within 28 days.\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including poloxamer 407 and sodium hyaluronate.\n5. History of allogeneic organ transplant.\n6. History of primary immunodeficiency.\n7. QTc interval \\>470 msec at Screening.","MALE","18 Years",{"count":126,"type":127},18,"ESTIMATED","INTERVENTIONAL",[130],"PHASE1","A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy",[133],"Prostate Cancer",[135,136,137,138,139,140,141,142,143,41,144,145,146],"Intraoperative","Dose escalation","Open-label","STM-416","Resiquimod","Toll-like receptor 7\u002F8","Radical prostatectomy","Robotic prostatectomy","Immunotherapy","PSA","R848","Hydrogel","2026-02-17",{"date":149,"type":150},"2026-02-19","ACTUAL",{"date":152,"type":150},"2025-05-08",{"date":154,"type":127},"2026-12",{"name":5,"class":6},4]