Status:
COMPLETED
Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Lead Sponsor:
Aura Biosciences
Conditions:
Uveal Melanoma
Ocular Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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/C...
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 belz...
Eligibility Criteria
Inclusion
- 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
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular disease
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04417530
Start Date
August 5 2020
End Date
April 22 2024
Last Update
March 3 2025
Active Locations (22)
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1
Retina Associates SW, P.C.
Tucson, Arizona, United States, 85710
2
UCLA Jules Stein Eye Institute
Los Angeles, California, United States, 90095
3
Byers Eye Institute at Stanford University
Palo Alto, California, United States, 94303
4
UCHealth Eye Center
Aurora, Colorado, United States, 80045