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Phase 1 Study of Belzupacap Sarotalocan (AU-011) for Bladder Cancer

This study is testing a new treatment called Belzupacap Sarotalocan (AU-011) for non-muscle-invasive bladder cancer (NMIBC). Researchers want to see how safe and practical it is to give AU-011 directly into bladder tumors, sometimes with a medical laser. You might be able to join if you are 18 or older and have a recent diagnosis of NMIBC. The main goal is to track any serious side effects or problems with the treatment for up to 12 months. This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. The study aims to enroll about 55 participants.

Study design
This is an open-label study, meaning you and your doctors will know the treatment you are receiving. It plans to enroll about 55 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05483868

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Aura Biosciences
~55 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:AU-011AU-011 in Combination with Medical Laser AdminstrationAU-011 in Combination with Medical Laser Administration

At a glance

Recruiting sites
0 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of AU-011: Incidences of SAEs and DLTs
Measured over up to 12 months

Conditions

Non-muscle-invasive Bladder Cancer
NMIBC
Non-Muscle Invasive Bladder Carcinoma
Non-Muscle Invasive Bladder Neoplasms
Non-Muscle Invasive Bladder Urothelial Carcinoma
Urothelial Carcinoma Bladder

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Bladder Carcinoma

NCT05483868

Where you'd take part

This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arkansas Urology

    Little Rock, Arkansasno site contact published

  • Austin Health

    Heidelberg, Victoria, Australiano site contact published

  • Baylor College of Medicine

    Houston, Texasno site contact published

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolinano site contact published

  • Colorado Clinical Research

    Lakewood, Coloradono site contact published

  • Hollywood Private Hospital

    Nedlands, Western Australia, Australiano site contact published

  • Montefiore Medical Center

    The Bronx, New Yorkno site contact published

  • Penninsula Private Hospital

    Langwarrin, Victoria, Australiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Monitor · STUDY_DIRECTOR · Aura Biosciences

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

For Cohorts 1b, 4a-c:
Multifocal LG Ta; OR
Solitary LG Ta \>3 cm; OR
Low-grade Ta with prior recurrence(s) within 1 year.
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

What this trial measures

  • Safety of AU-011: Incidences of SAEs and DLTsup 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 \[time frame 14 days\]