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NCT06007690Phase 3RECRUITING

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 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).

Conditions
Choroidal MelanomaIndeterminate LesionsUveal MelanomaOcular Melanoma
Interventions / Drugs
Bel-sarSuprachoroidal MicroinjectorInfrared LaserSham Infrared LaserSham Microinjector
View on ClinicalTrials.gov ↗
Sponsor
AURA
Aura Biosciences
Ocular Oncology
C56/100
Study Details
Enrollment100 participants
Primary Completion—
Lead SponsorAura Biosciences
Data Retrieved2026-04-11 02:55:09.188980+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 100 participants
Sponsor Catalyst Profile

Aura Biosciences (AURA) is the sponsoring company for this trial. BiotechSign currently grades this company C (56/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

AURA Full Pipeline →All Companies →
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