Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT05483868
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2022-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2022-07-20', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of AU-011: Incidences of SAEs and DLTs', 'timeFrame': 'up to 12 months', 'description': 'Incidence and severity of treatment-related adverse events \\[time frame 12 months\\], serious adverse events \\[time frame 12 months\\], and incidence of dose-limiting toxicities \\[time frame 14 days\\]'}], 'secondaryOutcomes': [{'measure': 'Complete response (CR) rate', 'timeFrame': 'at the 3-month time point and at TURBT', 'description': 'for all cohorts'}, {'measure': 'Duration of response (DoR)', 'timeFrame': '12 months', 'description': 'In participants who achieve CR'}, {'measure': 'Durable CR rate', 'timeFrame': '6-, 9-, and 12-month follow-up', 'description': 'Proportion of participants maintaining a CR after achieving a CR'}, {'measure': 'Recurrence-free survival (RFS)', 'timeFrame': '12 mos', 'description': 'Participants in neoadjuvant cohorts'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['NMIBC', 'TURBT', 'Intramural', 'AU-011', 'Belzupacap Sarotalocan', 'Intratumoral', 'urothelial', 'bladder cancer', 'bel-sar'], 'conditions': ['Non-muscle-invasive Bladder Cancer', 'Non-Muscle Invasive Bladder Cancer (&Amp;#34;NMIBC&Amp;#34;) Unresponsive/Intolerant to BCG', 'NMIBC', 'Non-Muscle Invasive Bladder Carcinoma', 'Non-Muscle Invasive Bladder Neoplasms', 'Non-Muscle Invasive Bladder Urothelial Carcinoma', 'Urothelial Carcinoma Bladder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Aura is enrolling participants with urothelial carcinoma to evaluate the safety, technical feasibility, and preliminary efficacy of bel-sar. The goal is to achieve the trial objectives with minimal disruption to the standard of care (SoC) of the treating Investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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 ≥5/6 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."}, 'identificationModule': {'nctId': 'NCT05483868', 'briefTitle': 'A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aura Biosciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AU-011-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Focal injections of AU-011 prior to TURBT (1b)', 'description': 'Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC.', 'interventionNames': ['Drug: AU-011']}, {'type': 'EXPERIMENTAL', 'label': 'Focal injections of AU-011 with laser application before TURBT (4a)', 'description': 'Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC.', 'interventionNames': ['Combination Product: AU-011 in Combination with Medical Laser Adminstration']}, {'type': 'EXPERIMENTAL', 'label': 'Focal injection of AU-011 with laser application before TURBT (4b)', 'description': 'Focal injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC.', 'interventionNames': ['Combination Product: AU-011 in Combination with Medical Laser Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Focal injection of AU-011 with laser application before TURBT (4c)', 'description': 'Focal injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC.', 'interventionNames': ['Combination Product: AU-011 in Combination with Medical Laser Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Focal injection of AU-011 and laser application with option for TURBT (4d)', 'description': 'Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (200 ug per lesion) with laser treatment and option for TURBT in patients with intermediate risk NMIBC. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment.', 'interventionNames': ['Combination Product: AU-011 in Combination with Medical Laser Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Focal injection of AU-011 and laser application with option for TURBT (4e)', 'description': 'Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation, with the option for TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment. Enrollment will occur in parallel with Cohort 4g, with randomized (1:1) assignment.', 'interventionNames': ['Combination Product: AU-011 in Combination with Medical Laser Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Focal injection of AU-011 and laser application with mandatory TURBT (4f)', 'description': 'Participants with high-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation prior to mandatory TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment.', 'interventionNames': ['Combination Product: AU-011 in Combination with Medical Laser Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Focal injection of AU-011 and laser application with optional TURBT (4g)', 'description': 'Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation with the option of TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment. Enrollment will occur in parallel with Cohort 4e, with randomized (1:1) assignment.', 'interventionNames': ['Combination Product: AU-011 in Combination with Medical Laser Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Focal injection of AU-011 and laser application with option for TURBT (4h)', 'description': 'Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (800 ug per lesion) with laser treatment and option for TURBT. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment. This arm is optional and will be run at the discretion of the sponsor.', 'interventionNames': ['Combination Product: AU-011 in Combination with Medical Laser Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Focal injection of AU-011 and laser application with mandatory TURBT (4i)', 'description': 'Participants with high-risk NMIBC will receive multiple treatment cycles of focal AU-011 (800 µg per lesion) before mandatory TURBT. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment. This arm is optional and will be run at the discretion of the sponsor.', 'interventionNames': ['Combination Product: AU-011 in Combination with Medical Laser Administration']}], 'interventions': [{'name': 'AU-011', 'type': 'DRUG', 'description': 'Administration of AU-011 intratumorally and intramurally', 'armGroupLabels': ['Focal injections of AU-011 prior to TURBT (1b)']}, {'name': 'AU-011 in Combination with Medical Laser Adminstration', 'type': 'COMBINATION_PRODUCT', 'description': 'AU-011 Intratumorally and Intramurally', 'armGroupLabels': ['Focal injections of AU-011 with laser application before TURBT (4a)']}, {'name': 'AU-011 in Combination with Medical Laser Administration', 'type': 'COMBINATION_PRODUCT', 'description': 'AU-011 Intratumorally', 'armGroupLabels': ['Focal injection of AU-011 and laser application with mandatory TURBT (4f)', 'Focal injection of AU-011 and laser application with mandatory TURBT (4i)', 'Focal injection of AU-011 and laser application with option for TURBT (4d)', 'Focal injection of AU-011 and laser application with option for TURBT (4e)', 'Focal injection of AU-011 and laser application with option for TURBT (4h)', 'Focal injection of AU-011 and laser application with optional TURBT (4g)', 'Focal injection of AU-011 with laser application before TURBT (4b)', 'Focal injection of AU-011 with laser application before TURBT (4c)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Arkansas Urology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Terry Williams', 'role': 'CONTACT', 'email': 'williamst@towerurology.com', 'phone': '310-854-9898', 'phoneExt': '178'}, {'name': 'David Josephson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tower Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frances Feng', 'role': 'CONTACT', 'email': 'frances.feng@providence.org'}], 'facility': "Saint John's Cancer Institute", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jerel Johnson', 'role': 'CONTACT', 'email': 'jerjohnson@montefiore.org'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '29272', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Richardson', 'role': 'CONTACT', 'email': 'jrichardson@curcmb.com'}], 'facility': 'Carolina Urologic Research Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '37209', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'SUSPENDED', 'country': 'United States', 'facility': 'Urology Associates, P.C.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Holly Baril', 'role': 'CONTACT', 'email': 'hbaril@urologyclinics.com', 'phone': '214-658-1987'}], 'facility': 'Urology Clinics of North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sharon Harrison', 'role': 'CONTACT', 'email': 'sharons@bcm.edu'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ahmad Abdel-Aziz', 'role': 'CONTACT', 'email': 'Abdelaziza1@uthscsa.edu'}], 'facility': 'The University of Texas San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stefanie Galvin', 'role': 'CONTACT', 'email': 'stefanie.galvin@usa-clinicaltrials.com'}], 'facility': 'Urology San Antonio/USA Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Olivia Soto', 'role': 'CONTACT', 'email': 'olivia@theupi.com', 'phone': '210-617-3670'}], 'facility': 'The Urology Place', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Dana Chatfield', 'role': 'CONTACT', 'email': 'ChatfieldD@ramsayhealth.com.au', 'phone': '+61 4 1943 4636'}, {'name': 'Manish Patel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westmead Private Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Robyn Bolger', 'role': 'CONTACT', 'email': 'Robyn.Bolger@austin.org.au', 'phone': '+61 3 9496 4915'}, {'name': 'Joseph Ischia', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Austin Health', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'city': 'Heidelberg', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Zahra Thompson', 'role': 'CONTACT', 'email': 'ThompsonZ@ramsayhealth.com.au', 'phone': '+61 456 359 569'}, {'name': 'Damien Bolton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Warringal Private Hospital', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '3910', 'city': 'Langwarrin', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'David McArdle', 'role': 'CONTACT', 'email': 'McArdleD@ramsayhealth.com.au', 'phone': '+61 3 9788 3647'}, {'name': 'George Koufogiannis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Penninsula Private Hospital', 'geoPoint': {'lat': -38.16667, 'lon': 145.16667}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Avanthika Lakshmanan', 'role': 'CONTACT', 'email': 'Avanthika.Lakshmanan@mh.org.au', 'phone': '+61 3 9342 7294'}, {'name': 'Paul Anderson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Eilish McCarthy', 'role': 'CONTACT', 'email': 'McCarthyEilish@ramsayhealth.com.au', 'phone': '+61 8 9346 6022'}, {'name': 'Tom Shannon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hollywood Private Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'centralContacts': [{'name': 'Medical Monitor', 'role': 'CONTACT', 'email': 'clinical@aurabiosciences.com', 'phone': '617-500-8864'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aura Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}