A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in Subjects With Metastases to the Choroid
Aura Biosciences
Summary
The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
Description
This is an open-label, dose escalation trial designed to assess safety and tolerability of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor. * Have at least one Metastases to the Choroid in the study eye Exclusion Criteria: * Active ocular infection or disease. * Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy per the primary treating oncologist's assessment. * Must not be planning or expecting to switch/add systemic antineoplastic therapies during treatment
Interventions
- DrugAU-011
AU-011 Via Suprachoroidal Administration with laser treatment
- DeviceSCS Microinjector
Suprachoroidal Injection Device
- DeviceLaser
Laser Administration
Locations (10)
- Byers Eye Institute at Stanford UniversityPalo Alto, California
- Bascom Palmer Eye InstituteMiami, Florida
- Massachusetts Eye and EarBoston, Massachusetts
- Kellogg Eye CenterAnn Arbor, Michigan
- Mayo ClinicRochester, Minnesota
- Cleveland Clinic, Cole Eye InstituteCleveland, Ohio