Clinical trial NCT05483868: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-muscle-invasive Bladder Cancer
Muscle-Invasive Bladder Carcinoma
Keywords: NMIBC
Cystectomy
TURBT
Intramural
AU-011
Belzupacap Sarotalocan
Intratumoral
MIBC
Lead sponsor: Aura Biosciences
Sponsor class: INDUSTRY
First posted: 2022-08-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety of AU-011: Incidences of SAEs and DLTs
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Santa Monica
country: United States
facility: Saint John's Cancer Institute
state: California
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: The University of Texas San Antonio
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio/USA Clinical Trials
state: Texas
Study officials:
References: