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

Active:	Yes
Cancer Type:	Eye Cancer Melanoma Unknown Primary	NCT ID:	NCT06007690
Trial Phases:	Phase III	Protocol IDs:	AU-011-301 (primary) NCI-2023-07465
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Aura Biosciences
NCI Full Details:	http://clinicaltrials.gov/show/NCT06007690

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).

Objectives

This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to
establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC)
administration in subjects with primary IL/CM. Bel-sar treatment incorporates
administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector
and activation of bel-sar by a laser photoactivation device.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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