The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    au-011-102
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05483868
Recruitment Status : Recruiting
First Posted : August 2, 2022
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
Aura Biosciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Non-muscle-invasive Bladder Cancer Muscle-Invasive Bladder Carcinoma Drug: AU-011 Combination Product: AU-011 in Combination with Medical Laser Adminstration Combination Product: AU-011 in Combination with Medical Laser Administration Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 26, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Drug: AU-011
Administration of AU-011 intratumorally and intramurally
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.
 Combination Product: AU-011 in Combination with Medical Laser Adminstration
AU-011 Intratumorally and Intramurally
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.
 Combination Product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
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.
 Combination Product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
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.
 Combination Product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
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.
 Combination Product: AU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05483868


Contacts
Layout table for location contacts
Contact: Medical Monitor 617-500-8864 clinical@aurabiosciences.com

Locations
Layout table for location information
United States, Arkansas
Arkansas Urology Terminated
Little Rock, Arkansas, United States, 72211
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Jerel Johnson       jerjohnson@montefiore.org   
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29272
Contact: Jennifer Sutton       jsutton@curcmb.com   
United States, Tennessee
Urology Associates, P.C. Recruiting
Nashville, Tennessee, United States, 37209
Contact: Mercedes Bruce       MBruce@ua-pc.com   
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75251
Contact: Joshua Matson    214-658-1987    jomatson@marycrowley.org   
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Sharon Harrison       sharons@bcm.edu   
The University of Texas San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Ahmad Abdel-Aziz       Abdelaziza1@uthscsa.edu   
Urology San Antonio/USA Clinical Trials Recruiting
San Antonio, Texas, United States, 78229
Contact: Karina Lozano       karina.lozano@usa-clinicaltrials.com   
Contact: Jose         
Sponsors and Collaborators
Aura Biosciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Aura Biosciences
ClinicalTrials.gov Identifier: NCT05483868    
Other Study ID Numbers: AU-011-102
First Posted: August 2, 2022    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Aura Biosciences:
NMIBC
Cystectomy
TURBT
Intramural
 AU-011
Belzupacap Sarotalocan
Intratumoral
MIBC
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type