Recruiting INTERVENTIONAL NCT05483868

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

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

Sponsor: Aura Biosciences

Conditions NMIBC Non-Muscle Invasive Bladder Carcinoma Non-Muscle Invasive Bladder Neoplasms Non-Muscle Invasive Bladder Urothelial Carcinoma Non-muscle-invasive Bladder Cancer Urothelial Carcinoma Bladder

Interventions AU-011 AU-011 in Combination with Medical Laser Administration AU-011 in Combination with Medical Laser Adminstration

Updated 12 times since 2022 Last updated: Apr 13, 2026 Started: Sep 26, 2022 Primary completion: Mar 1, 2027 Completion: Mar 1, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates NMIBC and Non-Muscle Invasive Bladder Carcinoma and is currently actively recruiting participants. Aura Biosciences leads this study, which shows 12 recorded versions since 2022 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

Aura is enrolling participants with urothelial carcinoma to evaluate the safety, technical feasibility, and preliminary efficacy of bel-sar. The goal is to achieve the trial objectives with minimal disruption to the standard of care (SoC) of the treating Investigator.

Status Flow

Change History

12 versions recorded

Apr 16, 2026 — Present [daily]

Recruiting

Phase: PHASE1 → None
Jan 2026 — Apr 2026 [monthly]

Recruiting PHASE1
Nov 2025 — Jan 2026 [monthly]

Recruiting PHASE1
Sep 2025 — Nov 2025 [monthly]

Recruiting PHASE1
Sep 2024 — Sep 2025 [monthly]

Recruiting PHASE1

▶ Show 7 earlier versions

Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE1
Apr 2024 — Jul 2024 [monthly]

Recruiting PHASE1
Dec 2023 — Apr 2024 [monthly]

Recruiting PHASE1
Jul 2023 — Dec 2023 [monthly]

Recruiting PHASE1
Mar 2023 — Jul 2023 [monthly]

Recruiting PHASE1
Nov 2022 — Mar 2023 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Sep 2022 — Nov 2022 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.

Contact Information

Sponsor contact:

Aura Biosciences

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Dallas, United States , Heidelberg, Australia , Heidelberg, Australia , Houston, United States , Langwarrin, Australia , Little Rock, United States , Los Angeles, United States , Myrtle Beach, United States , Nashville, United States , Nedlands, Australia and 7 more locations