Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
- Conditions
- Uveal MelanomaOcular MelanomaChoroidal Melanoma
- Interventions
- Registration Number
- NCT04417530
- Lead Sponsor
- Aura Biosciences
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 AU-011& Laser Suprachoroidal Microinjector Low dose of AU-011 + 1 laser application Cohort 1 AU-011& Laser PDT Laser Low dose of AU-011 + 1 laser application Cohort 2 AU-011 & Laser Suprachoroidal Microinjector Medium dose of AU-011 + 1 laser application Cohort 2 AU-011 & Laser PDT Laser Medium dose of AU-011 + 1 laser application Cohort 3 AU-011 (belzupacap sarotalocan) & Laser Suprachoroidal Microinjector Medium dose of AU-011 + 2 laser applications Cohort 3 AU-011 (belzupacap sarotalocan) & Laser PDT Laser Medium dose of AU-011 + 2 laser applications Cohort 4 AU-011 & Laser Suprachoroidal Microinjector Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments Cohort 4 AU-011 & Laser PDT Laser Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments Cohort 5 AU-011 & Laser Suprachoroidal Microinjector 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. Cohort 5 AU-011 & Laser PDT 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. Cohort 6 AU-011 & Laser Suprachoroidal Microinjector High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment. Cohort 6 AU-011 & Laser PDT Laser High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment. Cohort 1 AU-011& Laser AU-011 Low dose of AU-011 + 1 laser application Cohort 2 AU-011 & Laser AU-011 Medium dose of AU-011 + 1 laser application Cohort 3 AU-011 (belzupacap sarotalocan) & Laser AU-011 Medium dose of AU-011 + 2 laser applications Cohort 4 AU-011 & Laser AU-011 Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments Cohort 5 AU-011 & Laser AU-011 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. Cohort 6 AU-011 & Laser AU-011 High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
- Primary Outcome Measures
Name Time Method Treatment related AEs and treatment related serious adverse events (SAEs). 52 weeks Adverse Events
- Secondary Outcome Measures
Name Time Method Time to reach tumor progression 52 weeks Tumor progression
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks. 52 weeks Tumor Thickness Growth Rate
Trial Locations
- Locations (22)
UCLA Jules Stein Eye Institute
🇺🇸Los Angeles, California, United States
St. Thomas Health / Tennessee Retina, PC
🇺🇸Nashville, Tennessee, United States
Midwest Eye Institute
🇺🇸Carmel, Indiana, United States
University of Iowa Department of Ophthalmology and Visual Sciences
🇺🇸Iowa City, Iowa, United States
Byers Eye Institute at Stanford University
🇺🇸Palo Alto, California, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Retina Center
🇺🇸Minneapolis, Minnesota, United States
Dean McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Retina Consultants of Houston
🇺🇸Houston, Texas, United States
Oregon Health & Science University Casey Eye Institute
🇺🇸Portland, Oregon, United States
UCHealth Eye Center
🇺🇸Aurora, Colorado, United States
W. K. Kellogg Eye Center, University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Retina Associates SW, P.C.
🇺🇸Tucson, Arizona, United States
University of Illinois At Chicago Illinois Eye and Ear Infirmary
🇺🇸Chicago, Illinois, United States
Retina Associates of Florida
🇺🇸Tampa, Florida, United States
Emory Eye Center
🇺🇸Atlanta, Georgia, United States
Associated Retinal Consultants, PC
🇺🇸Royal Oak, Michigan, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
University of Wisconsin Dept of Ophthalmology & Visual Sciences
🇺🇸Madison, Wisconsin, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Retina Consultants of Carolina, PA
🇺🇸Greenville, South Carolina, United States