A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Who is this study for? Patients with Melanoma
What treatments are being studied? AU-011
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Arizona
Retina Associates SW, P.C.
Active, not recruiting
Tucson
California
UCLA Jules Stein Eye Institute
Active, not recruiting
Los Angeles
Byers Eye Institute at Stanford University
Recruiting
Palo Alto
Colorado
UCHealth Eye Center
Recruiting
Aurora
Florida
Retina Associates of Florida
Recruiting
Tampa
Georgia
Emory Eye Center
Active, not recruiting
Atlanta
Iowa
University of Iowa Department of Ophthalmology and Visual Sciences
Completed
Iowa City
Illinois
University of Illinois At Chicago Illinois Eye and Ear Infirmary
Not yet recruiting
Chicago
Indiana
Midwest Eye Institute
Recruiting
Carmel
Massachusetts
Massachusetts Eye and Ear Infirmary
Recruiting
Boston
Michigan
W. K. Kellogg Eye Center, University of Michigan
Recruiting
Ann Arbor
Associated Retinal Consultants, PC
Recruiting
Royal Oak
Minnesota
Retina Center
Completed
Minneapolis
New York
Columbia University Medical Center
Recruiting
New York
Oklahoma
Dean McGee Eye Institute
Recruiting
Oklahoma City
Oregon
Oregon Health & Science University Casey Eye Institute
Recruiting
Portland
Pennsylvania
Wills Eye Hospital
Active, not recruiting
Philadelphia
South Carolina
Retina Consultants of Carolina, PA
Recruiting
Greenville
Tennessee
St. Thomas Health / Tennessee Retina, PC
Recruiting
Nashville
Texas
Texas Retina Associates
Recruiting
Dallas
Retina Consultants of Houston
Recruiting
Houston
Wisconsin
University of Wisconsin Dept of Ophthalmology & Visual Sciences
Recruiting
Madison
Contact Information
Primary
Medical Monitor
clinical@aurabiosciences.com
617-500-8864
Time Frame
Start Date: August 5, 2020
Estimated Completion Date: September 30, 2024
Participants
Target number of participants: 22
Treatments
Experimental: Cohort 1 AU-011 & Laser
Low dose of AU-011 + 1 laser application
Experimental: Cohort 2 AU-011 & Laser
Medium dose of AU-011 + 1 laser application
Experimental: Cohort 3 AU-011 & Laser
Medium dose of AU-011 + 2 laser applications
Experimental: Cohort 4 AU-011 & Laser
Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Experimental: Cohort 5 AU-011 & Laser
AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
Experimental: Cohort 6 AU-011 & Laser
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
Sponsors
Leads: Aura Biosciences

This content was sourced from clinicaltrials.gov