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A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
Trial Status: active
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan
(bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or
small choroidal melanoma (CM).
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 naive for IL/CM (subjects who received PDT may be eligible)
Exclusion Criteria
Have known contraindications or sensitivities to the study drug or laser
Active ocular infection or disease
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06007690.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
Nebraska
Omaha
University of Nebraska Medical Center
Status: Active
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not Available
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Status: Active
Contact: Michael M Altaweel
Phone: 608-263-7171
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to
establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC)
administration in subjects with primary IL/CM. Bel-sar treatment incorporates
administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector
and activation of bel-sar by a laser photoactivation device.
