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NCT05483868 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Non-muscle Invasive Bladder Cancer and Urothelial Carcinoma Bladder, sponsored by Aura Biosciences.

Recruiting
Registry status
Phase 1
Development phase
55
Enrollment target
17
Study locations

NCT05483868 is a Phase 1 study of Non-muscle Invasive Bladder Cancer and Urothelial Carcinoma Bladder that is actively recruiting participants, run by Aura Biosciences. The registered enrollment target is 55 participants, below the 231-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (76% lower). The trial reports 17 study locations across 9 states.

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The verdict

NCT05483868, a Phase 1 study of Non-muscle Invasive Bladder Cancer and Urothelial Carcinoma Bladder, is actively recruiting participants, sponsored by Aura Biosciences.

RECRUITING
Registry status
Phase 1
Development phase
55 participants
Enrollment target
17
Study locations

Study 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.

Conditions Studied

Non-muscle Invasive Bladder Cancer Urothelial Carcinoma Bladder Non-Muscle Invasive Bladder Neoplasms Non-Muscle Invasive Bladder Urothelial Carcinoma Non-Muscle Invasive Bladder Carcinoma NMIBC Non-Muscle Invasive Bladder Cancer (&Amp;#34;NMIBC&Amp;#34;) Unresponsive/Intolerant to BCG

Interventions

  • DRUG AU-011
  • COMBINATION_PRODUCT AU-011 in Combination with Medical Laser Adminstration
  • COMBINATION_PRODUCT AU-011 in Combination with Medical Laser Administration

Study Locations (17)

Texas

  • Urology Clinics of North Texas - Dallas
  • Baylor College of Medicine - Houston
  • The University of Texas San Antonio - San Antonio
  • Urology San Antonio/USA Clinical Trials - San Antonio
  • The Urology Place - San Antonio

Victoria

  • Austin Health - Heidelberg
  • Warringal Private Hospital - Heidelberg
  • Penninsula Private Hospital - Langwarrin
  • The Royal Melbourne Hospital - Parkville

California

  • Tower Urology - Los Angeles
  • Saint John's Cancer Institute - Santa Monica

Arkansas

  • Arkansas Urology - Little Rock

New York

  • Montefiore Medical Center - The Bronx

South Carolina

  • Carolina Urologic Research Center - Myrtle Beach

Tennessee

  • Urology Associates, P.C. - Nashville

New South Wales

  • Westmead Private Hospital - Westmead

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2022-09-26
Est. Completion 2027-03
Phase Phase 1

Sponsor

Aura Biosciences

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05483868

The ClinicalTrials.gov registry entry for NCT05483868 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 231-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (76% lower). The listed sponsor is Aura Biosciences, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which AU-011 is the first listed.

NCT05483868 reports 17 study locations spanning 9 distinct geographic areas - top geographies include Texas, Victoria, California.

Frequently Asked Questions

What is clinical trial NCT05483868 about?

NCT05483868 is a clinical study titled "A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer". 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.

What is the current status of trial NCT05483868?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2022-09-26. Estimated completion is 2027-03.

What conditions does trial NCT05483868 study?

This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer, Urothelial Carcinoma Bladder, Non-Muscle Invasive Bladder Neoplasms, Non-Muscle Invasive Bladder Urothelial Carcinoma, Non-Muscle Invasive Bladder Carcinoma.

What interventions are being tested in trial NCT05483868?

The interventions under investigation include: AU-011 (DRUG), AU-011 in Combination with Medical Laser Adminstration (COMBINATION_PRODUCT), AU-011 in Combination with Medical Laser Administration (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05483868?

This trial is sponsored by Aura Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05483868 being conducted?

This trial has 17 study locations across Arkansas, California, New York, South Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.