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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aura Biosciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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