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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-muscle-invasive Bladder Cancer, Muscle-Invasive Bladder Carcinoma

Intervention / Treatment
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* Drug: AU-011
* Combination Product: AU-011 in Combination with Medical Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of NMIBC or MIBC. 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: Any additional malignancy that requires active 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. Any other subject felt appropriate by the Investigator upon discussion with 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. Chronic active hepatitis B or C and HIV.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intratumoral and intramural injection of AU-011 prior to TURBT<br>Intratumoral and intramural injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC. | Drug: AU-011<br>* Administration of AU-011 intratumorally or intratumorally and intramurally<br>|
| Experimental: Intratumoral and intramural injection of AU-011 with laser application before TURBT<br>Intratumoral and intramural injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC. | Combination Product: AU-011 in Combination with Medical Laser<br>* Administration of AU-011 intratumorally or intratumorally and intramurally with Laser application.<br>|
| Experimental: AU-011 intratumoral injection +/- intramural injection with laser application prior to cystectomy<br>Intratumoral +/- intramural injection of AU-011 with laser application followed by standard of care (cystectomy). | Combination Product: AU-011 in Combination with Medical Laser<br>* Administration of AU-011 intratumorally or intratumorally and intramurally with Laser application.<br>|
| Experimental: AU-011 intratumoral and intramural injection with laser application during TURBT<br>Intratumoral and intramural injection of AU-011 with laser application during standard of care (TURBT). | Combination Product: AU-011 in Combination with Medical Laser<br>* Administration of AU-011 intratumorally or intratumorally and intramurally with Laser application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of AU-011: Incidences of SAEs and DLTs | Incidence and severity of treatment-related adverse events and serious adverse events (SAEs) and incidence of dose-limiting toxicities (DLTs). | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of AU-011 | Focal distribution of AU-011 using immunohistochemical staining. | 9 days | 
| Assessment of tumor necrosis | Presence of focal necrosis in bladder tumor, based on histopathology in Cohorts 4, 5, and 6 | 9 days | 
| Safety of the laser device | Incidence of adverse device effects (ADEs) and serious adverse device effects (SADEs) with respect to the laser device. | 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NMIBC, Cystectomy, TURBT, Intramural, AU-011, Belzupacap Sarotalocan, Intratumoral, MIBC