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

• ClinicalTrials.gov Identifier: NCT05483868
• Recruitment Status: Recruiting
• First Posted: August 2, 2022
• Last Update Posted: March 5, 2024
• Sponsor: Aura Biosciences
• Information provided by (Responsible Party): Aura Biosciences

Tracking Information

• First Submitted Date: July 20, 2022
• First Posted Date: August 2, 2022
• Last Update Posted Date: March 5, 2024
• Actual Study Start Date: September 26, 2022
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2022)

Safety of AU-011: Incidences of SAEs and DLTs [ Time Frame: 56 days ]

Incidence and severity of treatment-related adverse events and serious adverse events (SAEs) and incidence of dose-limiting toxicities (DLTs).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: July 29, 2022)

• Distribution of AU-011 [ Time Frame: 9 days ]
  Distribution of AU-011 using immunohistochemical staining (distance measured by pathological sample in millimeters and overall area measured in millimeters squared).
• Area of Necrosis of Bladder Tumor [ Time Frame: 9 days ]
  Area of necrosis in bladder tumor base, based on histopathology samples in Cohorts 2, 3, and 4 (distance of necrosis measured by pathological sample in millimeters and overall area measured in millimeters squared).
• Degree of Necrosis of Bladder Tumor [ Time Frame: 9 days ]
  Degree of necrosis in bladder tumor base, based on histopathology samples in Cohorts 2, 3 and 4 (degree of necrosis to be estimated by a customized relative scale ranging from +1 to +4 based on Pathologist review).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
• 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
• Brief Summary: The main objectives of this study are to determine the feasibility and safety of AU-011 treatment of bladder cancer utilizing intratumoral injection with or without intramural injection and with or without laser application.
• Detailed Description: Aura is conducting a Phase 1, 'window of opportunity', open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibility and safety of intratumoral injection with or without intramural injection and with or without laser application in subjects with bladder cancer.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Non-muscle-invasive Bladder Cancer
• Muscle-Invasive Bladder Carcinoma

Intervention

• Drug: AU-011
  Administration of AU-011 intratumorally and intramurally
• Combination Product: AU-011 in Combination with Medical Laser Adminstration
  AU-011 Intratumorally and Intramurally
• Combination Product: AU-011 in Combination with Medical Laser Administration
  AU-011 Intratumorally

Study Arms

• Experimental: Intratumoral and intramural injection 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.
  Intervention: Drug: AU-011
• Experimental: Intratumoral and intramural injection 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.
  Intervention: Combination Product: AU-011 in Combination with Medical Laser Adminstration
• Experimental: Intratumoral injection of AU-011 with laser application before TURBT (4b)
  Intratumoral injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
  Intervention: Combination Product: AU-011 in Combination with Medical Laser Administration
• Experimental: Intratumoral injection of AU-011 with laser application before TURBT (4c)
  Intratumoral injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
  Intervention: Combination Product: AU-011 in Combination with Medical Laser Administration
• Experimental: AU-011 intratumoral injection with laser application prior to cystectomy (5a)
  Intratumoral injection of AU-011 (100 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC.
  Intervention: Combination Product: AU-011 in Combination with Medical Laser Administration
• Experimental: AU-011 intratumoral injection with laser application prior to cystectomy (5b)
  Intratumoral injection of AU-011 (200 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC.
  Intervention: Combination Product: AU-011 in Combination with Medical Laser Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 2, 2024): 21
• Original Estimated Enrollment (submitted: July 29, 2022): 23
• Estimated Study Completion Date: July 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Confirmed diagnosis urothelial carcinoma of the bladder (Recurrence of prior NMIBC biopsy or pathology must be obtained within 12 months prior to enrollment. First time NMIBC biopsy within 6 months of screening. MIBC allowed if demonstrated pathologically)
2. Have no evidence of metastatic disease
3. Adequate bone marrow, renal, and hepatic function

Exclusion Criteria:

1. Any additional malignancy that requires active treatment. Exceptions include:

   1. 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.
   2. In situ cervical cancer treated and with at least 1 year without recurrence.
   3. Any other subject felt appropriate by the Investigator upon discussion with 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. Chronic active hepatitis B or C and HIV.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Medical Monitor; 617-500-8864; clinical@aurabiosciences.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05483868
• Other Study ID Numbers: AU-011-102
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Aura Biosciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Aura Biosciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Aura Biosciences
• Verification Date: March 2024