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

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Study sites: 17 to 19
    v11
  2. Site details revised at 2 of 17 sitesv10
  3. Study sites: 10 to 17
    • Primary completion date: Dec 2026 to Mar 2027
    • Study completion date: Apr 2027 to Mar 2027
    v9
  4. Enrollment target: 21 to 55v8 Show 7 more changesShow less
    • Primary completion date: Jun 2024 to Dec 2026
    • Study sites: 9 to 10
    • Study completion date: Jul 2024 to Apr 2027
    • Eligibility criteria expanded, about 180 words
    • Secondary endpoints expanded, about 14 words
    • Study arms: 6 to 10
    • Study description shortened, about 1 word
  5. Study sites: 8 to 9v7
Show 5 earlier versionsHide 5 earlier versions
  1. Enrollment target: 19 to 21v6 Show 6 more changesShow less
    • Study sites: 6 to 8
    • Primary completion date: May 2024 to Jun 2024
    • Interventions: AU-011 (Drug), AU-011 in Combination with Medical Laser (Combination Product) to AU-011 (Drug), AU-011 in Combination with Medical Laser Administration (Combination Product), AU-011 in Combination with Medical Laser…
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints shortened, about 12 words
    • Study arms: 4 to 6
  2. Enrollment target: 23 to 19v5 Show 7 more changesShow less
    • Study sites: 4 to 6
    • Primary completion date: Dec 2023 to May 2024
    • Study completion date: Feb 2024 to Jul 2024
    • Eligibility criteria shortened, about 100 words
    • Secondary endpoints: 6 to 3
    • Study description shortened, about 22 words
    • Study title expanded, about 1 word
  3. Study sites: 3 to 4v4 Show 4 more changesShow less
    • Primary completion date: Jun 2023 to Dec 2023
    • Study completion date: Aug 2023 to Feb 2024
    • Eligibility criteria revised
    • Study title revised
  4. Study sites: 2 to 3v3 Show 4 more changesShow less
    • Primary completion date: Mar 2023 to Jun 2023
    • Study completion date: Jun 2023 to Aug 2023
    • Secondary endpoints: 3 to 6
    • Study description shortened, about 1 word
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Sep 26, 2022
    • Site details revised at 2 of 2 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Aura Biosciences
6 trials monitored
See 1 trial at risk
Bladder Cancer
1,055 trials monitored
See 74 trials at risk
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.
Trial Details
NCT Number NCT05483868
Lead Sponsor Aura Biosciences
Conditions
(from sponsor)		 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
Related terms Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov