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Study in Subjects With Small Primary Choroidal Melanoma

Sponsor
Aura Biosciences (Industry)
Overall Status
Completed
CT.gov ID
NCT03052127
Collaborator
(none)
57
Enrollment
13
Locations
12
Arms
46.9
Actual Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Light-activated AU-011
  • Device: Laser Activation
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 27, 2017
Actual Primary Completion Date :
Jan 26, 2021
Actual Study Completion Date :
Jan 26, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 [Informed consent through 2 years]

      Adverse events will be summarized by presenting the number and percentage of patients having any adverse event.

    Secondary Outcome Measures

    1. Immunogenicity [Screening to various time points through Week 52]

      Anti-Drug Antibody analysis

    2. Tumor size (thickness) measured by ultrasonography [Efficacy] [Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years)]

      Tumor size (thickness) measured by ultrasonography (millimeters)

    3. Tumor size (diameter) measured by fundus photography [Efficacy] [Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years)]

      Tumor size (diameter) measured by fundus photography (millimeters)

    4. Best Corrected Visual Acuity measured by ETDRS Method [Efficacy] [Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years)]

      Changes in ETDRS best corrected visual acuity (BCVA)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of choroidal melanoma
    Exclusion Criteria:
    • Have known contraindications or sensitivities to the study drug

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retina Associates SW, P.C. Tucson Arizona United States 85710
    2 UCLA Jules Stein Eye Institute Los Angeles California United States 90095
    3 Byers Eye Institute at Stanford University Palo Alto California United States 94303
    4 Retina Consultants of Sacramento Sacramento California United States 95819
    5 Colorado Retina Associates Denver Colorado United States 80210
    6 Massachusetts Eye and Ear Infirmary Boston Massachusetts United States 02114
    7 W. K. Kellogg Eye Center, University of Michigan Ann Arbor Michigan United States 48105
    8 Associated Retinal Consultants, PC Royal Oak Michigan United States 48073
    9 Retina Center Minneapolis Minnesota United States 55404
    10 Columbia University Medical Center New York New York United States 10027
    11 Wills Eye Hospital Philadelphia Pennsylvania United States 19107
    12 Retina Consultants of Carolina, PA Greenville South Carolina United States 29605
    13 Retina Consultants of Houston Houston Texas United States 77030

    Sponsors and Collaborators

    • Aura Biosciences

    Investigators

    • Study Director: Abhijit Narvekar, MBBS, Aura Biosciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aura Biosciences
    ClinicalTrials.gov Identifier:
    NCT03052127
    Other Study ID Numbers:
    • AU-011-101
    First Posted:
    Feb 14, 2017
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Aura Biosciences
    Uveal melanoma
    Eye cancer
    Ocular melanoma
    Choroidal melanoma
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Jan 14, 2022