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

December 13, 2023 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

22

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 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

Ages Eligible for Study

16 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
Intervention / Treatment
Experimental: Cohort 1 AU-011 & Laser
Low dose of AU-011 + 1 laser application
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser Administration
Experimental: Cohort 2 AU-011 & Laser
Medium dose of AU-011 + 1 laser application
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser Administration
Experimental: Cohort 3 AU-011 & Laser
Medium dose of AU-011 + 2 laser applications
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser 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
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser 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.
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser 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.
Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment
Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device
Device: PDT Laser
Laser Administration

What is the study measuring?

Primary Outcome Measures

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

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

Aura Biosciences

Investigators

  • 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)

August 5, 2020

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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