Uveal Melanoma Clinical Trial
Official title:
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
| Verified date | December 2023 |
| Source | Aura Biosciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
| Status | Active, not recruiting |
| Enrollment | 22 |
| Est. completion date | May 30, 2025 |
| Est. primary completion date | May 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | W. K. Kellogg Eye Center, University of Michigan | Ann Arbor | Michigan |
| United States | Emory Eye Center | Atlanta | Georgia |
| United States | UCHealth Eye Center | Aurora | Colorado |
| United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
| United States | Midwest Eye Institute | Carmel | Indiana |
| United States | University of Illinois At Chicago Illinois Eye and Ear Infirmary | Chicago | Illinois |
| United States | Texas Retina Associates | Dallas | Texas |
| United States | Retina Consultants of Carolina, PA | Greenville | South Carolina |
| United States | Retina Consultants of Houston | Houston | Texas |
| United States | University of Iowa Department of Ophthalmology and Visual Sciences | Iowa City | Iowa |
| United States | UCLA Jules Stein Eye Institute | Los Angeles | California |
| United States | University of Wisconsin Dept of Ophthalmology & Visual Sciences | Madison | Wisconsin |
| United States | Retina Center | Minneapolis | Minnesota |
| United States | St. Thomas Health / Tennessee Retina, PC | Nashville | Tennessee |
| United States | Columbia University Medical Center | New York | New York |
| United States | Dean McGee Eye Institute | Oklahoma City | Oklahoma |
| United States | Byers Eye Institute at Stanford University | Palo Alto | California |
| United States | Wills Eye Hospital | Philadelphia | Pennsylvania |
| United States | Oregon Health & Science University Casey Eye Institute | Portland | Oregon |
| United States | Associated Retinal Consultants, PC | Royal Oak | Michigan |
| United States | Retina Associates of Florida | Tampa | Florida |
| United States | Retina Associates SW, P.C. | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Aura Biosciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment related AEs and treatment related serious adverse events (SAEs). | Adverse Events | 52 weeks | |
| Secondary | Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks. | Tumor Thickness Growth Rate | 52 weeks | |
| Secondary | Time to reach tumor progression | Tumor progression | 52 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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