[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aura Biosciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":151},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,54,83,110,130],{"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":24,"conditions":25,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100476433","phase-1-a-phase-1-open-label-trial-of-belzupacap-sarotalocan-au-011-in-bladder-cancer-100476433",false,"NCT05483868","A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer","A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer","Inclusion Criteria:\n\n1. Meet the following histopathologic requirements for urothelial carcinoma:\n\n   * For Cohorts 1b, 4a-c:\n\n   histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 months of Screening Visit) is required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months).\n\n   For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to\n\n   AUA risk classification guidelines) is required, specifically:\n   * Multifocal LG Ta; OR\n   * Solitary LG Ta \\>3 cm; OR\n   * Low-grade Ta with prior recurrence(s) within 1 year.\n\n   For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:\n   * Ta HG papillary disease with or without CIS; OR\n   * T1 papillary disease with or without CIS\n   * Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)\n   * BCG-refractory participants are excluded. BCG-refractory is defined by the following:\n\n     * Persistent HG disease at 6 months following adequate BCG (defined as ≥5\u002F6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR\n     * HG T1 disease at first evaluation (3 months) after BCG, OR\n     * Persistent CIS that remains despite a second BCG course, OR\n     * Disease progression in stage or grade during BCG therapy, including maintenance\n2. Have no evidence of current or prior metastatic urothelial carcinoma\n3. Adequate bone marrow, renal, and hepatic function\n\nExclusion Criteria:\n\n1. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.\n2. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.\n3. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.\n4. Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids.\n5. Chronic active hepatitis B or C and HIV.","ALL","18 Years",{"count":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.",[26,27,28,29,30,31],"Non-muscle-invasive Bladder Cancer","NMIBC","Non-Muscle Invasive Bladder Carcinoma","Non-Muscle Invasive Bladder Neoplasms","Non-Muscle Invasive Bladder Urothelial Carcinoma","Urothelial Carcinoma Bladder",[27,33,34,35,36,37,38,39,40],"TURBT","Intramural","Belzupacap Sarotalocan","Intratumoral","urothelial","bladder cancer","bel-sar","AU-011","RECRUITING","2026-04-13",{"date":44,"type":45},"2026-04-15","ACTUAL",{"date":47,"type":45},"2022-09-26",{"date":49,"type":20},"2027-03",{"name":51,"class":52},"Aura Biosciences","INDUSTRY",17,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100565569","phase-2-suprachoroidal-administration-in-subjects-with-metastases-to-the-choroid-100565569","NCT06643884","Suprachoroidal Administration in Subjects With Metastases to the Choroid","A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in Subjects With Metastases to the Choroid","Inclusion Criteria:\n\n* Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor.\n* Have at least one Metastases to the Choroid in the study eye\n\nExclusion Criteria:\n\n* Active ocular infection or disease.\n* Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy per the primary treating oncologist's assessment.\n* Must not be planning or expecting to switch\u002Fadd systemic antineoplastic therapies during treatment",{"count":62,"type":20},24,[64],"PHASE2","The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.",[67,68],"Eye Cancer","Primary Cancer",[70,71,72,73],"Choroidal Metastasis","Metastases to the Choroid","ocular","eye","2026-03-11",{"date":76,"type":45},"2026-03-13",{"date":78,"type":45},"2024-12-16",{"date":80,"type":20},"2027-10-31",{"name":51,"class":52},10,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100516681","phase-3-a-phase-3-randomized-masked-controlled-trial-to-evaluate-efficacy-and-safety-of-belzupacap-sarotalocan-au-011-treatment-compared-to-sham-control-in-subjects-with-primary-indeterminate-lesions-or-small-choroidal-melanoma-100516681","NCT06007690","A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma","CoMpass","Inclusion Criteria:\n\n* Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL\u002FCM)\n* Have no evidence of metastatic disease confirmed by imaging\n* Be treatment naive for IL\u002FCM (subjects who received PDT may be eligible)\n\nExclusion Criteria:\n\n* Have known contraindications or sensitivities to the study drug or laser\n* Active ocular infection or disease",{"count":91,"type":20},100,[93],"PHASE3","The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).",[96,97,98,99],"Choroidal Melanoma","Indeterminate Lesions","Uveal Melanoma","Ocular Melanoma",[98,67,99,96],"2026-02-26",{"date":103,"type":45},"2026-03-02",{"date":105,"type":45},"2023-12-06",{"date":107,"type":20},"2028-08-15",{"name":51,"class":52},71,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":128,"locationsCount":129},"100625369","choroidal-melanoma-patient-reported-outcome-study-cm-pro-in-a-subset-of-au-011-301-compass-subjects-100625369","NCT07421739","Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects","Inclusion Criteria:\n\n* Have enrolled in the Aura-sponsored clinical trial AU-011-301.\n* Access to a connected device (i.e., smartphone, laptop, or tablet)\n\nExclusion Criteria:\n\n* None",{"count":117,"type":20},15,"OBSERVATIONAL","To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.",[96,97,98,99],[98,67,99,96],"2026-02-17",{"date":124,"type":45},"2026-02-19",{"date":126,"type":45},"2025-11-12",{"date":107,"type":20},{"name":51,"class":52},1,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":88,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":4},"100619003","a-long-term-follow-up-study-of-subjects-completing-the-au-011-301compass-for-early-choroidal-melanoma-100619003","NCT07338968","A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma","A Long-Term Follow-Up Study of Subjects Completing the AU-011-301 (CoMpass) Trial of Bel-sar for Early Choroidal Melanoma (Indeterminate Lesions\u002FSmall Choroidal Melanomas)","Inclusion Criteria:\n\n* Have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301.\n* Be willing and able to consent to the AU-011-403 study.\n\nExclusion Criteria:\n\n* None",{"count":91,"type":20},"AU-011-403 is a multicenter long-term follow-up safety and efficacy study of subjects with early CM who previously participated in the AU-011-301 Phase 3 trial. There are no required interventions or use of AU-011 (bel-sar) in this long-term follow-up study",[96,97],[99,141],"Small Choroidal Melanoma","NOT_YET_RECRUITING","2026-01-07",{"date":145,"type":45},"2026-01-14",{"date":147,"type":20},"2026-02-01",{"date":149,"type":20},"2033-08-15",{"name":51,"class":52},""]