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
Launched by AURA BIOSCIENCES · Aug 17, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called belzupacap sarotalocan (bel-sar) for patients with early-stage eye conditions known as primary indeterminate lesions or small choroidal melanoma. The goal is to see how safe and effective this treatment is compared to a sham control, which means some participants will receive the actual treatment while others will receive a placebo that looks like the treatment but contains no active medication. This trial is currently recruiting participants aged 65 to 74 who have been diagnosed with one of these eye conditions but have not received previous treatment for them.
To be eligible for the study, participants must have a confirmed diagnosis of either primary indeterminate lesions or small choroidal melanoma and must not have any signs of cancer spread to other parts of the body. Participants should also not have any known allergies to the study drug or the laser used in the treatment and must not have any active eye infections. Those who join the study can expect to receive either the new treatment or the sham control, and they will be closely monitored for any side effects or improvements in their condition throughout the trial.
Gender
ALL
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 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
About Aura Biosciences
Aura Biosciences is a clinical-stage biotechnology company focused on developing innovative therapies for ocular oncology. Their proprietary platform leverages a unique approach to target and eradicate cancer cells while preserving healthy tissue, with a primary emphasis on treating rare eye cancers such as uveal melanoma. Committed to advancing patient care, Aura Biosciences aims to bring transformative solutions to the field of ophthalmology through rigorous clinical trials and a dedication to scientific excellence.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
Chicago, Illinois, United States
Rochester, Minnesota, United States
Dallas, Texas, United States
Miami, Florida, United States
Chicago, Illinois, United States
Seattle, Washington, United States
Saint Louis, Missouri, United States
Seattle, Washington, United States
Rochester, Minnesota, United States
Austin, Texas, United States
Oklahoma City, Oklahoma, United States
Leuven, , Belgium
Cleveland, Ohio, United States
Ann Arbor, Michigan, United States
London, , United Kingdom
Tampa, Florida, United States
New York, New York, United States
Nashville, Tennessee, United States
Palo Alto, California, United States
Madison, Wisconsin, United States
Chattanooga, Tennessee, United States
Durham, North Carolina, United States
Salt Lake City, Utah, United States
Bellevue, Washington, United States
Boston, Massachusetts, United States
Rochester, New York, United States
Greenville, South Carolina, United States
Brisbane, Queensland, Australia
Southlake, Texas, United States
The Woodlands, Texas, United States
Lakewood, Colorado, United States
La Jolla, California, United States
Sacramento, California, United States
Berlin, , Germany
Lübeck, , Germany
San Antonio, Texas, United States
Birmingham, Alabama, United States
Boston, Massachusetts, United States
Royal Oak, Michigan, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
The Woodlands, Texas, United States
Columbus, Ohio, United States
East Melbourne, Victoria, Australia
Liverpool, England, United Kingdom
London, England, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Los Angeles, California, United States
San Francisco, California, United States
Boston, Massachusetts, United States
Salt Lake City, Utah, United States
Calgary, Alberta, Canada
Québec City, Quebec, Canada
Liverpool, England, United Kingdom
Sheffield, , United Kingdom
Wayne, New Jersey, United States
Philadelphia, Pennsylvania, United States
Toronto, Ontario, Canada
Tel Hashomer, Hamerkaz, Israel
Jerusalem, Yerushalayim, Israel
Calgary, Alberta, Canada
Plzen, Plzenský Kraj, Czechia
Praha 6, , Czechia
Nice, Cedex 1, France
Leiden, , Netherlands
Nice, , France
Praha 4, Krč, Czechia
Praha 4, , Czechia
Plzen, , Czechia
Patients applied
Trial Officials
Medical Monitor
Study Director
Aura Biosciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported