RecruitingInterventionalPhase 2

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

NCT ID: NCT06643884Sponsor: Aura BiosciencesLast updated: 2026-03-13

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.

Arms & interventions

DrugAU-011
AU-011 Via Suprachoroidal Administration with laser treatment
DeviceSCS Microinjector
Suprachoroidal Injection Device
DeviceLaser
Laser Administration

Outcome measures

Primary

Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.
B-Scan Ultrasonography
Time frame: 4 weeks after completion of treatment
Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.
Fundus photos
Time frame: 4 weeks after completion of treatment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (10)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303

Recruiting

Bascom Palmer Eye Institute

Miami, Florida, 33136

Recruiting

Massachusetts Eye and Ear

Boston, Massachusetts, 02114

Recruiting

Kellogg Eye Center

Ann Arbor, Michigan, 48105

Recruiting

Mayo Clinic

Rochester, Minnesota, 55905

Not Yet Recruiting

Cleveland Clinic, Cole Eye Institute

Cleveland, Ohio, 44195

Not Yet Recruiting

Shields and Shields, PC

Philadelphia, Pennsylvania, 19107

Not Yet Recruiting

Tennessee Retina, PC

Nashville, Tennessee, 37203

Recruiting

Retina Consultants of Texas

Bellaire, Texas, 77401

Recruiting

University of Washington

Seattle, Washington, 98104

Recruiting