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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).
This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 AU-011& Laser | Experimental | Low dose of AU-011 + 1 laser application |
|
| Cohort 2 AU-011 & Laser | Experimental | Medium dose of AU-011 + 1 laser application |
|
| Cohort 3 AU-011 (belzupacap sarotalocan) & Laser | Experimental | Medium dose of AU-011 + 2 laser applications |
|
| Cohort 4 AU-011 & Laser | Experimental | Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments |
|
| Cohort 5 AU-011 & Laser | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AU-011 | Drug | AU-011 Via Suprachoroidal Administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related AEs and treatment related serious adverse events (SAEs). | Adverse Events | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks. | Tumor Thickness Growth Rate | 52 weeks |
| Time to reach tumor progression | Tumor progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Aura Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Associates SW, P.C. | Tucson | Arizona | 85710 | United States | ||
| UCLA Jules Stein Eye Institute |
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| Label | URL |
|---|---|
| Aura Biosciences | View source |
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|
| Cohort 6 AU-011 & Laser | Experimental | High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment. |
|
| Suprachoroidal Microinjector | Device | Suprachoroidal Injection Device |
|
| PDT Laser | Device | Laser Administration |
|
| 52 weeks |
| Los Angeles |
| California |
| 90095 |
| United States |
| Byers Eye Institute at Stanford University | Palo Alto | California | 94303 | United States |
| UCHealth Eye Center | Aurora | Colorado | 80045 | United States |
| Retina Associates of Florida | Tampa | Florida | 33609 | United States |
| Emory Eye Center | Atlanta | Georgia | 30322 | United States |
| University of Illinois At Chicago Illinois Eye and Ear Infirmary | Chicago | Illinois | 60612 | United States |
| Midwest Eye Institute | Carmel | Indiana | 46290 | United States |
| University of Iowa Department of Ophthalmology and Visual Sciences | Iowa City | Iowa | 52242 | United States |
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| W. K. Kellogg Eye Center, University of Michigan | Ann Arbor | Michigan | 48105 | United States |
| Associated Retinal Consultants, PC | Royal Oak | Michigan | 48073 | United States |
| Retina Center | Minneapolis | Minnesota | 55404 | United States |
| Columbia University Medical Center | New York | New York | 10027 | United States |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health & Science University Casey Eye Institute | Portland | Oregon | 97239 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Retina Consultants of Carolina, PA | Greenville | South Carolina | 29605 | United States |
| St. Thomas Health / Tennessee Retina, PC | Nashville | Tennessee | 37203 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| University of Wisconsin Dept of Ophthalmology & Visual Sciences | Madison | Wisconsin | 53705 | United States |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D005134 | Eye Neoplasms |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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