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Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Uveal Melanoma Clinical Trial

Official title:
A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Clinical Trial Summary

The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

Clinical Trial Description

This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04417530
Study type Interventional
Source Aura Biosciences
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 5, 2020
Completion date May 30, 2025
View Details
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