A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
1 other identifier
interventional
55
2 countries
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2022
Longer than P75 for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
August 2, 2022
CompletedStudy Start
First participant enrolled
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 15, 2026
April 1, 2026
4.4 years
July 20, 2022
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of AU-011: Incidences of SAEs and DLTs
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 \[time frame 14 days\]
up to 12 months
Secondary Outcomes (4)
Complete response (CR) rate
at the 3-month time point and at TURBT
Duration of response (DoR)
12 months
Durable CR rate
6-, 9-, and 12-month follow-up
Recurrence-free survival (RFS)
12 mos
Study Arms (10)
Focal injections of AU-011 prior to TURBT (1b)
EXPERIMENTALIntratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC.
Focal injections of AU-011 with laser application before TURBT (4a)
EXPERIMENTALIntratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC.
Focal injection of AU-011 with laser application before TURBT (4b)
EXPERIMENTALFocal injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
Focal injection of AU-011 with laser application before TURBT (4c)
EXPERIMENTALFocal injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
Focal injection of AU-011 and laser application with option for TURBT (4d)
EXPERIMENTALParticipants 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.
Focal injection of AU-011 and laser application with option for TURBT (4e)
EXPERIMENTALParticipants 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.
Focal injection of AU-011 and laser application with mandatory TURBT (4f)
EXPERIMENTALParticipants 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.
Focal injection of AU-011 and laser application with optional TURBT (4g)
EXPERIMENTALParticipants 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.
Focal injection of AU-011 and laser application with option for TURBT (4h)
EXPERIMENTALParticipants 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.
Focal injection of AU-011 and laser application with mandatory TURBT (4i)
EXPERIMENTALParticipants 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.
Interventions
Administration of AU-011 intratumorally and intramurally
AU-011 Intratumorally and Intramurally
AU-011 Intratumorally
Eligibility Criteria
You may qualify if:
- Meet the following histopathologic requirements for urothelial carcinoma:
- 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
- +4 more criteria
You may not qualify if:
- Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.
- 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.
- 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.
- 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.
- Chronic active hepatitis B or C and HIV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aura Bioscienceslead
Study Sites (17)
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Tower Urology
Los Angeles, California, 90048, United States
Saint John's Cancer Institute
Santa Monica, California, 90404, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29272, United States
Urology Associates, P.C.
Nashville, Tennessee, 37209, United States
Urology Clinics of North Texas
Dallas, Texas, 75251, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
The University of Texas San Antonio
San Antonio, Texas, 78229, United States
Urology San Antonio/USA Clinical Trials
San Antonio, Texas, 78229, United States
The Urology Place
San Antonio, Texas, 78240, United States
Westmead Private Hospital
Westmead, New South Wales, 2145, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Warringal Private Hospital
Heidelberg, Victoria, Australia
Penninsula Private Hospital
Langwarrin, Victoria, 3910, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Aura Biosciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
August 2, 2022
Study Start
September 26, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share