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Testing a new treatment for bladder cancer using AU-011

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

Phase 1 Interventional Aura Biosciences · NCT05483868

This study is testing a new treatment called AU-011 for bladder cancer to see if it is safe and effective for patients with different types of the disease.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment55 (estimated)
Ages18 Years and up
SexAll
SponsorAura Biosciences Industry-sponsored
Locations17 sites (Little Rock, Arkansas and 16 other locations)
Trial IDNCT05483868 on ClinicalTrials.gov

What this trial studies

This Phase 1 open-label trial aims to evaluate the feasibility and safety of belzupacap sarotalocan (AU-011) for treating bladder cancer. Participants will receive intratumoral injections of AU-011, with some also receiving intramural injections and/or laser treatment. The study focuses on patients with non-muscle-invasive and muscle-invasive bladder carcinoma, assessing the treatment's effectiveness and safety profile. The trial is designed as a 'window of opportunity' to explore the potential benefits of this innovative approach.

Who should consider this trial

Good fit: Ideal candidates include individuals with confirmed urothelial carcinoma of the bladder who have no evidence of metastatic disease.

Not a fit: Patients with active malignancies requiring treatment or those who have recently participated in other investigational studies may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients with bladder cancer.

How similar studies have performed: While this approach is novel, similar studies exploring intratumoral therapies have shown promise in other cancer types.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Little Rock, Arkansas and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-muscle-invasive Bladder CancerNMIBCNon-Muscle Invasive Bladder CarcinomaNon-Muscle Invasive Bladder NeoplasmsNon-Muscle Invasive Bladder Urothelial CarcinomaUrothelial Carcinoma BladderTURBTIntramural
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.