[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SURGE Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100493875","phase-1-a-study-of-stm-416-administered-to-patients-undergoing-turbt-for-recurrent-bladder-cancer-100493875",false,"NCT05710848","A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer","A Phase 1\u002F2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer","Inclusion Criteria:\n\n1. Are aged 18 years or older;\n2. Have a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously, with recurrent papillary disease seen on cystoscopy, and who are undergoing TURBT without perioperative intravesical chemotherapy;\n3. Are considered high risk for recurrence;\n4. Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;\n5. Have adequate organ and marrow function as defined below:\n\n   * Hemoglobin 9.0 g\u002FdL;\n   * Absolute neutrophil count 1.5 × 109\u002FL (1500 per mm3);\n   * Platelet count 75 × 109\u002FL (75,000 per mm3);\n   * Serum bilirubin 1.5 × institutional upper limit of normal (ULN);\n   * AST (serum glutamic-oxaloacetic transaminase)\u002FALT (serum glutamic-pyruvic transaminase) 2.5 × institutional ULN; and\n   * Creatinine CL 60 mL\u002Fmin by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL: Males: Creatinine CL (mL\u002Fmin) = Weight (kg) × (140 - Age)\u002F72 × serum creatinine (mg\u002FdL); or Females: Creatinine CL (mL\u002Fmin) = Weight (kg) × (140 - Age) × 0.85\u002F72 × serum creatinine (mg\u002FdL).\n\nExclusion Criteria:\n\n1. Have a history of CIS or MIBC;\n2. Are receiving any other investigational agents;\n3. Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to resiquimod (R848), or excipients used in STM-416 including poloxamer 407 and sodium hyaluronate;\n4. Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\n   Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher;\n5. Are a woman of childbearing potential regardless of contraceptive use; Note: Women of childbearing potential are only to be excluded in Phase 1 and Phase 2a to avoid bias due to the low prevalence of NMIBC in this population. However, they will be included in subsequent Phase 2\u002F3 studies.","ALL","18 Years",{"count":19,"type":20},75,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a first-in-human (FIH), Phase 1\u002F2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.",[27],"Non-muscle-invasive Bladder Cancer",[29,30,31,32,33,34,35,36,37],"Open-label","Dose escalation","STM-416","Resiquimod","Toll-like receptor 7\u002F8","Non-Muscle Invasive Bladder Cancer","TURBT","Immunotherapy","BCG","RECRUITING","2026-05-23",{"date":41,"type":42},"2026-05-27","ACTUAL",{"date":44,"type":42},"2023-07-11",{"date":46,"type":20},"2026-08",{"name":48,"class":49},"SURGE Therapeutics","INDUSTRY",20,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100550671","phase-1-study-of-stm-416p-administered-to-patients-undergoing-radical-prostatectomy-100550671","NCT06450106","Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy","A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively 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",{"count":60,"type":20},18,[23],"A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy",[64],"Prostate Cancer",[66,30,29,31,32,33,67,68,36,69,70,71,72],"Intraoperative","Radical prostatectomy","Robotic prostatectomy","STM-416p","PSA","R848","Hydrogel","2026-02-17",{"date":75,"type":42},"2026-02-19",{"date":77,"type":42},"2025-05-08",{"date":79,"type":20},"2026-12",{"name":48,"class":49},4,""]