A Phase 1b/2 Open-Label, Ascending Single And Repeat Dose Clinical Trial Designed To Evaluate The Safety and Efficacy of Light-Activated AU-011 For The Treatment of Subjects With Small to Medium Primary Choroidal Melanoma

Protocol: 
AAAR2880
Phase: 
I/II

A Phase 1b/2 Open-Label, Ascending Single And Repeat Dose Clinical Trial Designed To Evaluate The Safety and Efficacy of Light-Activated AU-011 For The Treatment of Subjects With Small to Medium Primary Choroidal Melanoma

The purpose of this research study is to test the safety of Light-activated
AU-011 at three different doses of the study drug and repeat dose regimens
(two or three doses of highest safe dose) to find out what effects, if any,
it has on research participants with a choroidal melanoma tumor. This study
will have a high dose, a medium dose, and a low dose of Light-activated AU-
011.

Are you Eligible? (Inclusion Criteria)

Inclusion:
-Be at least 18 years of age
-Have clinically diagnosed primary CM, with no known metastatic disease, ≥
2.0 mm and ≤ 3.4 mm in height, and longest basal diameter ≤ 16 mm.
-. Have primary CM with documented tumor growth on B-scan and/or fundus
photos, OR have primary CM with presence of subretinal fluid by OCT, AND at
least one of the following:
a. Overlying orange pigment (lipofuscin) on fundus photos
b. Vision loss
c. Flashes or floaters

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States