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.
Brief Title
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
617-500-8864
Central Contact Email
clinical@aurabiosciences.com
Completion Date
Completion Date Type
Estimated
Conditions
Non-muscle-invasive Bladder Cancer
Muscle-Invasive Bladder Carcinoma
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.
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.
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
NMIBC
Cystectomy
TURBT
Intramural
AU-011
Belzupacap Sarotalocan
Intratumoral
MIBC
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05483868
Org Class
Industry
Org Full Name
Aura Biosciences
Org Study Id
AU-011-102
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
Incidence and severity of treatment-related adverse events and serious adverse events (SAEs) and incidence of dose-limiting toxicities (DLTs).
Outcome Measure
Safety of AU-011: Incidences of SAEs and DLTs
Outcome Time Frame
56 days
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alexander Sankin
Investigator Email
asankin@montefiore.org