Trial Title:
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
NCT ID:
NCT05483868
Condition:
Non-muscle-invasive Bladder Cancer
Muscle-Invasive Bladder Carcinoma
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
NMIBC
Cystectomy
TURBT
Intramural
AU-011
Belzupacap Sarotalocan
Intratumoral
MIBC
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AU-011
Description:
Administration of AU-011 intratumorally and intramurally
Arm group label:
Intratumoral and intramural injection of AU-011 prior to TURBT (1b)
Intervention type:
Combination Product
Intervention name:
AU-011 in Combination with Medical Laser Adminstration
Description:
AU-011 Intratumorally and Intramurally
Arm group label:
Intratumoral and intramural injection of AU-011 with laser application before TURBT (4a)
Intervention type:
Combination Product
Intervention name:
AU-011 in Combination with Medical Laser Administration
Description:
AU-011 Intratumorally
Arm group label:
AU-011 intratumoral injection with laser application prior to cystectomy (5a)
Arm group label:
AU-011 intratumoral injection with laser application prior to cystectomy (5b)
Arm group label:
Intratumoral injection of AU-011 with laser application before TURBT (4b)
Arm group label:
Intratumoral injection of AU-011 with laser application before TURBT (4c)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arkansas Urology
Address:
City:
Little Rock
Zip:
72211
Country:
United States
Status:
Terminated
Facility:
Name:
Saint John's Cancer Institute
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Frances Feng
Email:
mailto:frances.feng@providence.org
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jerel Johnson
Email:
jerjohnson@montefiore.org
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29272
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Sutton
Email:
jsutton@curcmb.com
Facility:
Name:
Urology Associates, P.C.
Address:
City:
Nashville
Zip:
37209
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mercedes Bruce
Email:
MBruce@ua-pc.com
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joshua Matson
Phone:
214-658-1987
Email:
jomatson@marycrowley.org
Facility:
Name:
Baylor College of Medicine
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sharon Harrison
Email:
sharons@bcm.edu
Facility:
Name:
The University of Texas San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ahmad Abdel-Aziz
Email:
Abdelaziza1@uthscsa.edu
Facility:
Name:
Urology San Antonio/USA Clinical Trials
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karina Lozano
Email:
karina.lozano@usa-clinicaltrials.com
Contact backup:
Last name:
Jose
Start date:
September 26, 2022
Completion date:
July 2024
Lead sponsor:
Agency:
Aura Biosciences
Agency class:
Industry
Source:
Aura Biosciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05483868