A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

August 5, 2026 updated by: Aura Biosciences

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Private Hospital
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Heidelberg, Victoria, Australia
        • Warringal Private Hospital
      • Langwarrin, Victoria, Australia, 3910
        • Penninsula Private Hospital
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Hollywood Private Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology
    • California
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • Santa Monica, California, United States, 90404
        • Saint John's Cancer Institute
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Colorado Clinical Research
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29272
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Urology Associates, P.C.
    • Texas
      • Dallas, Texas, United States, 75251
        • Urology Clinics Of North Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78240
        • The Urology Place
      • San Antonio, Texas, United States, 78229
        • The University of Texas San Antonio
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio/USA Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
      • 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:

  1. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: AU-011
Administration of AU-011 intratumorally and intramurally
Other Names:
  • belzupacap sarotalocan
Experimental: 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.
Combination product: AU-011 in Combination with Medical Laser Adminstration
AU-011 Intratumorally and Intramurally
Other Names:
  • belzupacap sarotalocan
Experimental: 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.
Combination product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Other Names:
  • belzupacap sarotalocan
Experimental: 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.
Combination product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Other Names:
  • belzupacap sarotalocan
Experimental: 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.
Combination product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Other Names:
  • belzupacap sarotalocan
Experimental: 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.
Combination product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Other Names:
  • belzupacap sarotalocan
Experimental: 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.
Combination product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Other Names:
  • belzupacap sarotalocan
Experimental: 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.
Combination product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Other Names:
  • belzupacap sarotalocan
Experimental: 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.
Combination product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Other Names:
  • belzupacap sarotalocan
Experimental: 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.
Combination product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Other Names:
  • belzupacap sarotalocan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of AU-011: Incidences of SAEs and DLTs
Time Frame: up to 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response (CR) rate
Time Frame: at the 3-month time point and at TURBT
for all cohorts
at the 3-month time point and at TURBT
Duration of response (DoR)
Time Frame: 12 months
In participants who achieve CR
12 months
Durable CR rate
Time Frame: 6-, 9-, and 12-month follow-up
Proportion of participants maintaining a CR after achieving a CR
6-, 9-, and 12-month follow-up
Recurrence-free survival (RFS)
Time Frame: 12 mos
Participants in neoadjuvant cohorts
12 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aura Biosciences

Investigators

  • Study Director: Medical Monitor, Aura Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-011-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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