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A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intramural Injection With or Without Intratumoral Injection in Subjects With Non-muscle Invasive Bladder Cancer (NMIBC)


  • Org Study ID: AU-011-102
  • Secondary ID: N/A
  • NTC ID: NCT05483868
  • Sponsor: Aura Biosciences


The main objectives of this study are i) to evaluate the incidence of AU-011 treatment-related adverse events, serious adverse events (SAEs) and dose-limiting toxicities (DLTs) and ii) to determine the feasibility of AU-011 treatment of non-muscle invasive bladder cancer utilizing intramural with or without intratumoral injection.


Aura is conducting a Phase 1, 'window of opportunity', open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibility and safety of intramural injection with or without intratumoral injection in subjects with non-muscle invasive bladder cancer (NMIBC). This study will evaluate distribution of AU-011 using immunohistochemical staining, area and degree of necrosis in bladder tumor base and evidence of an immune response.

  • Overall Status
  • Start Date
    September 26, 2022
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure: Safety of AU-011: Incidences of SAEs and DLTs

Primary Outcome 1 - Timeframe: 56 days


  • Non-muscle-invasive Bladder Cancer


Inclusion Criteria:
Have NMIBC with urothelial carcinoma confirmed by histopathology (note: if recurrent lesion, previous tumor biopsy is acceptable). Biopsy or pathology must be obtained within 6 months prior to enrollment

- Have no evidence of metastatic disease

- Have a normal upper urinary tract

- Adequate bone marrow, renal, and hepatic function
Exclusion Criteria:
Current or history of muscle invasive (i.e., T2 or higher) bladder cancer per AUA guideline or metastatic urothelial carcinoma.
Any additional malignancy that requires treatment. Exceptions include:
Basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy with evidence of remission for at least 1 year.

- In situ cervical cancer treated and with at least 1 year without recurrence.
Localized prostate cancer under active care that was treated with definitive therapy (surgically or through radiation therapy) is acceptable, provided that the following criteria are met:
Stage T2N0M0 or lower; prostate-specific antigen (PSA) undetectable for 2 years while off androgen deprivation therapy or no more than 2 consecutive rising PSAs.

- Tumors can be low or intermediate risk prostate cancer under active surveillance.

- Any significant illness or clinically significant laboratory abnormalities that the Investigator determines could interfere with trial participation or put the subject at any unnecessary risk.

- 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.

- Chronic active hepatitis B or C.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 617-500-8864

Email: clinical@aurabiosciences.com


Facility Status Contact
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29272
United States
Status: Recruiting Contact: Contact
Jennifer Sutton
Facility: Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Mercedes Bruce

Facility: Mary Crowley Cancer Research
Dallas, Texas 75251
United States
Status: Recruiting Contact: Contact
Joshua Matson

Facility: Baylor College of Medicine
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Sharon Harrison