Suprachoroidal bel‑sar (AU‑011) for metastases in 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
This trial will try injecting bel‑sar (AU‑011) under the eye's choroid to see if it is safe and tolerable for people with choroidal metastases from solid tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aura Biosciences Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 10 sites (Palo Alto, California and 9 other locations) |
| Trial ID | NCT06643884 on ClinicalTrials.gov |
What this trial studies
This is an open‑label, Phase 2 dose‑escalation trial testing four dose levels of bel‑sar (AU‑011) delivered suprachoroidally using a microinjector, with adjunct laser as specified in the protocol. Participants will receive one to two treatment cycles and be monitored for safety, ocular tolerability, and adverse events. Subjects must have at least one histologically or cytologically confirmed metastasis to the choroid in the treated eye and no active ocular infection or brain metastases requiring radiation. The trial is being conducted at three US academic ophthalmology centers and focuses on local delivery to limit systemic exposure.
Who should consider this trial
Good fit: Ideal candidates are adults with at least one histologically or cytologically confirmed metastasis to the choroid in the study eye, without active ocular infection and not planning changes to systemic anti‑cancer therapy during treatment.
Not a fit: Patients with active ocular infection or disease, brain metastases requiring radiation, or those planning to change or add systemic antineoplastic therapy are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a localized treatment option to control choroidal metastases while minimizing systemic side effects and potentially preserving vision.
How similar studies have performed: Localized ocular delivery approaches have shown promise in early‑phase work for other intraocular tumors, but suprachoroidal dosing of bel‑sar for choroidal metastases represents a novel application with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palo Alto, California and 9 other locations
- Byers Eye Institute at Stanford University — Palo Alto, California, United States (Recruiting)
- Bascom Palmer Eye Institute — Miami, Florida, United States (Recruiting)
- Massachusetts Eye and Ear — Boston, Massachusetts, United States (Recruiting)
- Kellogg Eye Center — Ann Arbor, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
- Cleveland Clinic, Cole Eye Institute — Cleveland, Ohio, United States (Not_yet_recruiting)
- Shields and Shields, PC — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Tennessee Retina, PC — Nashville, Tennessee, United States (Recruiting)
- Retina Consultants of Texas — Bellaire, Texas, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Medical Monitor
- Email: clinical@aurabiosciences.com
- Phone: 617-500-8864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.