Clinical Trial

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

Study acronym: CoMpass
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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).
Protocol Amendment History 2 changes
critical Enrollment closed, study ongoing 2026-08-01
notable Trial sites reduced: 71 -> 66 locations 2026-08-01
Trial Details
NCT Number NCT06007690
Lead Sponsor Aura Biosciences
Conditions Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma
Enrollment 108 participants
Start Date 2023-12-06
Primary Completion 2027-11-15 (estimated)
Study Completion 2028-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-31