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

INTRODUCTION

  • Org Study ID: AU-011-102
  • Secondary ID: N/A
  • NCT ID: NCT05483868
  • Sponsor: Aura Biosciences

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.

  • Overall Status
    Recruiting
  • Start Date
    September 26, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Safety of AU-011: Incidences of SAEs and DLTs

Primary Outcome 1 - Timeframe: 56 days

CONDITION

  • Non-muscle-invasive Bladder Cancer
  • Muscle-Invasive Bladder Carcinoma

ELIGIBILITY

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

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Medical Monitor

Phone: 617-500-8864

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Saint John's Cancer Institute
Santa Monica, California 90404
United States
Status: Recruiting Contact: Contact
Frances Feng
mailto:[email protected]

Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: Contact
Jerel Johnson
[email protected]

Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29272
United States
Status: Recruiting Contact: Contact
Jennifer Sutton
[email protected]

Facility: Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Mercedes Bruce
[email protected]

Facility: Mary Crowley Cancer Research
Dallas, Texas 75251
United States
Status: Recruiting Contact: Contact
Joshua Matson
214-658-1987
[email protected]

Facility: Baylor College of Medicine
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Sharon Harrison
[email protected]

Facility: The University of Texas San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Ahmad Abdel-Aziz
[email protected]

Facility: Urology San Antonio/USA Clinical Trials
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Karina Lozano
[email protected]

Contact
Jose