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

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

Trial Details

NCT ID
NCT06007690
Phase
PHASE3
Sponsor
Aura Biosciences
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Bel-sar
  • Suprachoroidal Microinjector
  • Infrared Laser
  • Sham Infrared Laser
  • Sham Microinjector
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • La Jolla, California, United States|32.84727,-117.2742
  • Palo Alto, California, United States|37.44188,-122.14302
  • Miami, Florida, United States|25.77427,-80.19366
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
  • Have no evidence of metastatic disease confirmed by imaging
  • Be treatment naive for IL/CM (subjects who received PDT may be eligible)

For full eligibility, visit ClinicalTrials.gov.

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