NCT04417530

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Aura Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Uveal Melanoma
• Ocular Melanoma
• Choroidal Melanoma

Interventions

Type	Name	Description
DRUG	AU-011	AU-011 Via Suprachoroidal Administration
DEVICE	Suprachoroidal Microinjector	Suprachoroidal Injection Device
DEVICE	PDT Laser	Laser Administration

Timeline

• Start date: 2020-08-05
• Primary completion: 2024-04-22
• Completion: 2024-04-22
• First posted: 2020-06-04
• Last updated: 2025-03-03

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study