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

NCT05483868 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-04-15

No results posted yet for this 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

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

Interventions

DRUG

AU-011

Administration of AU-011 intratumorally and intramurally

COMBINATION_PRODUCT

AU-011 in Combination with Medical Laser Adminstration

AU-011 Intratumorally and Intramurally

COMBINATION_PRODUCT

AU-011 in Combination with Medical Laser Administration

AU-011 Intratumorally

Sponsors & Collaborators

  • Aura Biosciences

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Aura Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05483868 on ClinicalTrials.gov