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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Sponsored by Aura Biosciences (industry) · AURA — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
108actual
Sites
66
Countries
Australia, Austria, Belgium +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-06 | actual | When the study began enrolling |
| Primary completion | 2027-11-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-08-15 | estimated | The whole study's end, after follow-up |
| First posted | 2023-08-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Choroidal Melanoma
- Indeterminate Lesions
- Uveal Melanoma
- Ocular Melanoma
Interventions
- Drug: Bel-sar — also filed as AU-011
- Device: Suprachoroidal Microinjector — also filed as SCS Microinjector
- Device: Infrared Laser
- Device: Sham Infrared Laser
- Device: Sham Microinjector
Primary outcome
what the primary-completion date above is the date OFTime to reach tumor progression
measured 65 weeks
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