A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
NCT ID: NCT05483868
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
55 participants
INTERVENTIONAL
2022-09-26
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Focal injection of AU-011 and laser application with option for TURBT (4e)
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.
AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Focal injection of AU-011 and laser application with mandatory TURBT (4f)
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.
AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Focal injection of AU-011 and laser application with optional TURBT (4g)
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.
AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Focal injection of AU-011 and laser application with option for TURBT (4h)
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.
AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Focal injection of AU-011 and laser application with mandatory TURBT (4i)
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.
AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Focal injections of AU-011 prior to TURBT (1b)
Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC.
AU-011
Administration of AU-011 intratumorally and intramurally
Focal injections of AU-011 with laser application before TURBT (4a)
Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC.
AU-011 in Combination with Medical Laser Adminstration
AU-011 Intratumorally and Intramurally
Focal injection of AU-011 with laser application before TURBT (4b)
Focal injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Focal injection of AU-011 with laser application before TURBT (4c)
Focal injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Focal injection of AU-011 and laser application with option for TURBT (4d)
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.
AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Interventions
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AU-011
Administration of AU-011 intratumorally and intramurally
AU-011 in Combination with Medical Laser Adminstration
AU-011 Intratumorally and Intramurally
AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Eligibility Criteria
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Inclusion Criteria
* For Cohorts 1b, 4a-c:
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).
For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to
AUA risk classification guidelines) is required, specifically:
* Multifocal LG Ta; OR
* Solitary LG Ta \>3 cm; OR
* Low-grade Ta with prior recurrence(s) within 1 year.
For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:
* Ta HG papillary disease with or without CIS; OR
* T1 papillary disease with or without CIS
* Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)
* BCG-refractory participants are excluded. BCG-refractory is defined by the following:
* 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
* HG T1 disease at first evaluation (3 months) after BCG, OR
* Persistent CIS that remains despite a second BCG course, OR
* Disease progression in stage or grade during BCG therapy, including maintenance
2. Have no evidence of current or prior metastatic urothelial carcinoma
3. Adequate bone marrow, renal, and hepatic function
Exclusion Criteria
2. 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.
3. 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.
4. 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.
5. Chronic active hepatitis B or C and HIV.
18 Years
ALL
No
Sponsors
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Aura Biosciences
INDUSTRY
Responsible Party
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Locations
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Arkansas Urology
Little Rock, Arkansas, United States
Tower Urology
Los Angeles, California, United States
Saint John's Cancer Institute
Santa Monica, California, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
The University of Texas San Antonio
San Antonio, Texas, United States
Urology San Antonio/USA Clinical Trials
San Antonio, Texas, United States
The Urology Place
San Antonio, Texas, United States
Westmead Private Hospital
Westmead, New South Wales, Australia
Austin Health
Heidelberg, Victoria, Australia
Warringal Private Hospital
Heidelberg, Victoria, Australia
Penninsula Private Hospital
Langwarrin, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Hollywood Private Hospital
Nedlands, Washington, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AU-011-102
Identifier Type: -
Identifier Source: org_study_id
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