RecruitingPhase 2NCT06643884
Suprachoroidal Administration in Subjects With Metastases to the Choroid
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
Sponsor
Aura Biosciences
Enrollment
24 participants
Start Date
Dec 16, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- 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 Criteria3
- 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
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Interventions
DRUGAU-011
AU-011 Via Suprachoroidal Administration with laser treatment
DEVICESCS Microinjector
Suprachoroidal Injection Device
DEVICELaser
Laser Administration
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06643884