Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

February 27, 2025 updated by: Aura Biosciences

A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

Study Overview

Status

Status

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

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, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.

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 (Actual)

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.
22

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 Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Retina Associates SW, P.C.
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Jules Stein Eye Institute
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute at Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • UCHealth Eye Center
    • Florida
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Eye Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois At Chicago Illinois Eye and Ear Infirmary
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Midwest Eye Institute
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Department of Ophthalmology and Visual Sciences
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • W. K. Kellogg Eye Center, University of Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants, PC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Retina Center
    • New York
      • New York, New York, United States, 10027
        • Columbia University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean McGee Eye Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Casey Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Retina Consultants of Carolina, PA
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • St. Thomas Health / Tennessee Retina, PC
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Dept of Ophthalmology & Visual Sciences

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
  • Have no evidence of metastatic disease confirmed by imaging
  • Be treatment naïve for IL/CM

Exclusion Criteria:

  • Have known contraindications or sensitivities to the study drug or laser
  • Active ocular disease

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.
Experimental: Cohort 2 AU-011 & Laser
Medium dose of AU-011 + 1 laser application
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser Administration
Drug: AU-011
AU-011 Via Suprachoroidal Administration
Experimental: Cohort 5 AU-011 & Laser
AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser Administration
Drug: AU-011
AU-011 Via Suprachoroidal Administration
Experimental: Cohort 6 AU-011 & Laser
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser Administration
Drug: AU-011
AU-011 Via Suprachoroidal Administration
Experimental: Cohort 1 AU-011& Laser
Low dose of AU-011 + 1 laser application
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser Administration
Drug: AU-011
AU-011 Via Suprachoroidal Administration
Experimental: Cohort 3 AU-011 (belzupacap sarotalocan) & Laser
Medium dose of AU-011 + 2 laser applications
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser Administration
Drug: AU-011
AU-011 Via Suprachoroidal Administration
Experimental: Cohort 4 AU-011 & Laser
Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser Administration
Drug: AU-011
AU-011 Via Suprachoroidal 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
Treatment related AEs and treatment related serious adverse events (SAEs).
Time Frame: 52 weeks
Adverse Events
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
Time Frame: 52 weeks
Tumor Thickness Growth Rate
52 weeks
Time to reach tumor progression
Time Frame: 52 weeks
Tumor progression
52 weeks

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
August 5, 2020

Primary Completion (Actual)

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.
April 22, 2024

Study Completion (Actual)

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.
April 22, 2024

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).
June 2, 2020

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.
June 2, 2020

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.
June 4, 2020

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 25, 2025

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.
February 27, 2025

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.
February 1, 2025

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-011-202

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.

Clinical Trials on Ocular Melanoma

Clinical Trials on Suprachoroidal Microinjector

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings