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

March 2, 2024 updated by: Aura Biosciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Terminated
        • Arkansas Urology
    • New York
      • Bronx, New York, United States, 10461
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29272
        • Recruiting
        • Carolina Urologic Research Center
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates, P.C.
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75251
        • Recruiting
        • Mary Crowley Cancer Research
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional 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 (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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
56 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aura Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-011-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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