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

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).

Inclusion Criteria

Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
Have no evidence of metastatic disease confirmed by imaging
Be treatment naïve for IL/CM

Exclusion Criteria

Have known contraindications or sensitivities to the study drug or laser
Active ocular disease

Additional locations may be listed on ClinicalTrials.gov for NCT04417530.

See trial information on ClinicalTrials.gov for a list of participating sites.

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.

Trial PhasePhase II

Trial Typetreatment

Lead OrganizationAura Biosciences

Primary IDAU-011-202
Secondary IDsNCI-2020-04854
ClinicalTrials.gov IDNCT04417530

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

Inclusion Criteria

Exclusion Criteria

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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

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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