Melanoma Clinical Trial

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

Summary

The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT04417530

Recruitment Status:

Active, not recruiting

Sponsor:

Aura Biosciences

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There are 22 Locations for this study

See Locations Near You

Retina Associates SW, P.C.
Tucson Arizona, 85710, United States
UCLA Jules Stein Eye Institute
Los Angeles California, 90095, United States
Byers Eye Institute at Stanford University
Palo Alto California, 94303, United States
UCHealth Eye Center
Aurora Colorado, 80045, United States
Retina Associates of Florida
Tampa Florida, 33609, United States
Emory Eye Center
Atlanta Georgia, 30322, United States
University of Illinois At Chicago Illinois Eye and Ear Infirmary
Chicago Illinois, 60612, United States
Midwest Eye Institute
Carmel Indiana, 46290, United States
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City Iowa, 52242, United States
Massachusetts Eye and Ear Infirmary
Boston Massachusetts, 02114, United States
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor Michigan, 48105, United States
Associated Retinal Consultants, PC
Royal Oak Michigan, 48073, United States
Retina Center
Minneapolis Minnesota, 55404, United States
Columbia University Medical Center
New York New York, 10027, United States
Dean McGee Eye Institute
Oklahoma City Oklahoma, 73104, United States
Oregon Health & Science University Casey Eye Institute
Portland Oregon, 97239, United States
Wills Eye Hospital
Philadelphia Pennsylvania, 19107, United States
Retina Consultants of Carolina, PA
Greenville South Carolina, 29605, United States
St. Thomas Health / Tennessee Retina, PC
Nashville Tennessee, 37203, United States
Texas Retina Associates
Dallas Texas, 75231, United States
Retina Consultants of Houston
Houston Texas, 77030, United States
University of Wisconsin Dept of Ophthalmology & Visual Sciences
Madison Wisconsin, 53705, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT04417530

Recruitment Status:

Active, not recruiting

Sponsor:


Aura Biosciences

How clear is this clinincal trial information?

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