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.
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.
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
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There are 22 Locations for this study
Tucson Arizona, 85710, United States
Los Angeles California, 90095, United States
Palo Alto California, 94303, United States
Aurora Colorado, 80045, United States
Tampa Florida, 33609, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60612, United States
Carmel Indiana, 46290, United States
Iowa City Iowa, 52242, United States
Boston Massachusetts, 02114, United States
Ann Arbor Michigan, 48105, United States
Royal Oak Michigan, 48073, United States
Minneapolis Minnesota, 55404, United States
New York New York, 10027, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19107, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75231, United States
Houston Texas, 77030, United States
Madison Wisconsin, 53705, United States
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