Suprachoroidal Administration in Subjects With Metastases to the Choroid

March 11, 2026 updated by: Aura Biosciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Byers Eye Institute at Stanford University
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Bascom Palmer Eye Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts Eye and Ear
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • Kellogg Eye Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic, Cole Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Shields and Shields, PC
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Retina, PC
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Retina Consultants of Texas
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observational
Subjects that meet trial inclusion, but do not meet criteria for enrollment into the bel-sar treatment cohorts, may be enrolled in this cohort. The observational cohort will not receive bel-sar treatment.
Experimental: 80 micrograms of bel-sar
1 Cycle AU-011 with a dose of 80 micrograms
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: SCS Microinjector
Suprachoroidal Injection Device
Device: Laser
Laser Administration
Experimental: 200 micrograms of bel-sar with one cycle
1 Cycle AU-011 with a dose of 200 micrograms
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: SCS Microinjector
Suprachoroidal Injection Device
Device: Laser
Laser Administration
Experimental: 200 micrograms of bel-sar with two cycles
2 Cycles AU-011 with a dose of 200 micrograms
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: SCS Microinjector
Suprachoroidal Injection Device
Device: Laser
Laser Administration
Experimental: 140 micrograms of bel-sar
1 Cycle AU-011 with a dose of 140 micrograms
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: SCS Microinjector
Suprachoroidal Injection Device
Device: Laser
Laser Administration
Experimental: 40 micrograms of bel-sar with one cycle
1 Cycle AU-011 with a dose of 40 micrograms
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: SCS Microinjector
Suprachoroidal Injection Device
Device: Laser
Laser Administration
Experimental: 40 micrograms of bel-sar with two cycles
2 Cycles AU-011 with a dose of 40 micrograms
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: SCS Microinjector
Suprachoroidal Injection Device
Device: Laser
Laser Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.
Time Frame: 4 weeks after completion of treatment
B-Scan Ultrasonography
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.
Time Frame: 4 weeks after completion of treatment
Fundus photos
4 weeks after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aura Biosciences

Investigators

  • Study Director: Medical Monitor, Aura Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-011-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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