Eye Cancer, Primary Cancer
Conditions
Keywords
Choroidal Metastasis, Metastases to the Choroid, ocular, eye
Brief 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.
Detailed 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.
Interventions
DRUGAU-011
AU-011 Via Suprachoroidal Administration with laser treatment
DEVICESCS Microinjector
Suprachoroidal Injection Device
DEVICELaser
Laser Administration
Sponsors
Aura Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment. | 4 weeks after completion of treatment | B-Scan Ultrasonography |
| Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment. | 4 weeks after completion of treatment | Fundus photos |
Countries
United States
Contacts
CONTACTMedical Monitor
STUDY_DIRECTORMedical Monitor
Aura Biosciences
Outcome results
None listed