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A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

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Trial Profile

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 May 2025

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At a glance

  • Drugs Belzupacap sarotalocan (Primary)
  • Indications Uveal melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms CoMpass
  • Sponsors Aura Biosciences

Most Recent Events

  • 15 May 2025 According to an Aura Biosciences media release, company expects study enrollment may be completed as early as the end of 2025.
  • 24 Mar 2025 According to an Aura Biosciences media release, the trial is actively enrolling patients globally. To identify appropriate patients to meet the enrichment strategy of documented growth, the Company has enabled a pre-screening 'run in' period. Globally, since June 2024, investigators have registered over 175 patients in pre-screening as having met initial enrollment criteria for the study. The acceleration in pre-screening is driven by increasing momentum in the United States and European Union.
  • 12 Nov 2024 According to an Aura Biosciences media release, The Company recently received authorization from the EMA to commence the trial under the European Union (EU) Clinical Trial Regulation (CTR) process. This approval was later than anticipated due to a requirement for additional testing to support drug substance characterization that has been successfully met. This permits the Company to start enrolling patients in the study in the EU.

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