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
Eye Cancer
Melanoma
Unknown Primary
18 Years and older, Male and Female
AU-011-301 (primary)
NCI-2023-07465
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.
Eligibility
- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- Have no evidence of metastatic disease confirmed by imaging
- Be treatment naive for IL/CM (subjects who received PDT may be eligible)
Treatment Sites in Georgia
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