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

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 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

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.
57

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
  • 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

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

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

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: 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

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
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

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
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

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: 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)

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.
February 27, 2017

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.
January 26, 2021

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.
January 26, 2021

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).
February 6, 2017

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.
February 9, 2017

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.
February 14, 2017

Study Record Updates

Last Update Posted (Estimated)

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.
February 1, 2024

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.
January 30, 2024

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.
January 1, 2024

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-011-101

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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