Study in Subjects With Small Primary Choroidal Melanoma

January 30, 2024 updated by: Aura Biosciences

A Phase 1B/2 Open-Label, Ascending Single and Repeat Dose Clinical Trial Designed to Evaluate the Safety and Efficacy of Light-activated AU-011 for the Treatment of Subjects With Small Primary Choroidal Melanoma

The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma.

Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2
  • Phase 1

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
      • Sacramento, California, United States, 95819
        • Retina Consultants of Sacramento
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Retina Associates
    • 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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Retina Consultants of Carolina, PA
    • Texas
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of choroidal melanoma

Exclusion Criteria:

  • Have known contraindications or sensitivities to the study drug

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: Single Low Dose Light-activated AU-011
Low dose Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: Single Medium Dose Light-activated AU-011
Medium dose Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: Single High Dose Light-activated AU-011
High dose Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: 2 Repeat Medium Dose Light-activated AU-011
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: 3 Repeat Medium Dose Light-activated AU-011
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: Single High Dose Light-activated AU-011 x 2 lasers
High dose Light-activated AU-011 followed by two laser light applications
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: 3 Repeat High Dose Light-activated AU-011
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: 3 Repeat High Dose Light-activated AU-011 x 2 lasers
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: Observation until Documented Growth of Tumor
Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: 2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser
Experimental: Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Drug: Light-activated AU-011
Study treatment
Device: Laser Activation
Study treatment
Other Names:
  • PDT Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Time Frame: Informed consent through 1-2 years
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
Informed consent through 1-2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity (Anti-AU-011 Antibody Analysis)
Time Frame: Screening to various time points through 24 months
Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)
Screening to various time points through 24 months
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Time Frame: Change from baseline following treatment and at each subsequent visit through Week 52
Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.
Change from baseline following treatment and at each subsequent visit through Week 52
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Time Frame: Change from baseline following treatment and at each subsequent visit through Week 52
Change from Baseline in tumor Largest Basal Diameter (LBD) assessed at each study visit based on fundus photos (millimeters) in participants treated with AU-011.
Change from baseline following treatment and at each subsequent visit through Week 52
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Time Frame: Change from baseline following treatment and at each subsequent visit through Week 52
Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.
Change from baseline following treatment and at each subsequent visit through Week 52

Collaborators and Investigators

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

Sponsor

Aura Biosciences

Investigators

  • Study Director: Abhijit Narvekar, MBBS, 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)

February 27, 2017

Primary Completion (Actual)

January 26, 2021

Study Completion (Actual)

January 26, 2021

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (Actual)

February 14, 2017

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-011-101

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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