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Non-muscle-invasive Bladder CancerPhase 1NCT05483868

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

A Phase 1 study testing AU-011, AU-011 in Combination with Medical Laser Adminstration and AU-011 in Combination with Medical Laser Administration in people with Non-muscle-invasive Bladder Cancer and NMIBC, run by Aura Biosciences at 19 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AU-011, AU-011 in Combination with Medical Laser Adminstration and AU-011 in Combination with Medical Laser Administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
19 sitesin 2 countries
Study dates
26 Sep 2022to Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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
  • Have no evidence of current or prior metastatic urothelial carcinoma
  • Adequate bone marrow, renal, and hepatic function

Who cannot join

  • 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.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States13 sites

  • Urology Clinics of North Texas

    Dallas, Texas, 75251

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • Tower Urology

    Los Angeles, California, 90048

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29272

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • The University of Texas San Antonio

    San Antonio, Texas, 78229

  • Urology San Antonio/USA Clinical Trials

    San Antonio, Texas, 78229

  • The Urology Place

    San Antonio, Texas, 78240

  • Saint John's Cancer Institute

    Santa Monica, California, 90404

  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

Australia6 sites

  • Austin Health

    Heidelberg, Victoria, 3084

  • Warringal Private Hospital

    Heidelberg, Victoria

  • Penninsula Private Hospital

    Langwarrin, Victoria, 3910

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Westmead Private Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Being tested
AU-011, AU-011 in Combination with Medical Laser Adminstration, AU-011 in Combination with Medical Laser Administration
Keywords
NMIBC, TURBT, Intramural, Belzupacap Sarotalocan, Intratumoral, urothelial, bladder cancer, bel-sar, AU-011
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AU-011Drug

    Also called belzupacap sarotalocan

    Administration of AU-011 intratumorally and intramurally

  • AU-011 in Combination with Medical Laser AdminstrationCombination product

    Also called belzupacap sarotalocan

    AU-011 Intratumorally and Intramurally

  • AU-011 in Combination with Medical Laser AdministrationCombination product

    Also called belzupacap sarotalocan

    AU-011 Intratumorally

Study groups in NCT05483868
Study groupRoleWhat they receive
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.
Receives: Drug: AU-011
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.
Receives: Combination Product: AU-011 in Combination with Medical Laser Adminstration
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.
Receives: Combination Product: AU-011 in Combination with Medical Laser Administration
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.
Receives: Combination Product: AU-011 in Combination with Medical Laser Administration
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.
Receives: Combination Product: AU-011 in Combination with Medical Laser Administration
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.
Receives: Combination Product: AU-011 in Combination with Medical Laser Administration
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.
Receives: Combination Product: AU-011 in Combination with Medical Laser Administration
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.
Receives: Combination Product: AU-011 in Combination with Medical Laser Administration
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.
Receives: Combination Product: AU-011 in Combination with Medical Laser Administration
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.
Receives: Combination Product: AU-011 in Combination with Medical Laser Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    Measured: up to 12 months

Secondary outcomes (4)

  1. Complete response (CR) rate

    for all cohorts

    Measured: at the 3-month time point and at TURBT

  2. Duration of response (DoR)

    In participants who achieve CR

    Measured: 12 months

  3. Durable CR rate

    Proportion of participants maintaining a CR after achieving a CR

    Measured: 6-, 9-, and 12-month follow-up

  4. Recurrence-free survival (RFS)

    Participants in neoadjuvant cohorts

    Measured: 12 mos

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start26 Sep 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05483868
Sponsor's protocol ID
AU-011-102
Status last verified
Aug 2026
First submitted
20 Jul 2022
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AU-011, AU-011 in Combination with Medical Laser Adminstration and AU-011 in Combination with Medical Laser Administration in people with Non-muscle-invasive Bladder Cancer and NMIBC, run by Aura Biosciences at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of AU-011: Incidences of SAEs and DLTs (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05483868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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