ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    au-011-101
Previous Study | Return to List | Next Study

Phase 1B/2 Study in Subjects With Small to Medium Primary Choroidal Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03052127
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Aura Biosciences

Brief Summary:
The primary objective is to assess the safety, immunogenicity and preliminary 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
Uveal Melanoma Ocular Melanoma Choroidal Melanoma Drug: Light-activated AU-011 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 preliminary efficacy of Light-activated AU-011 for the treatment of subjects with small to medium 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  (Clinical Trial)
Estimated Enrollment : 45 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 Preliminary Efficacy of Light-activated AU-011 for the Treatment of Subjects With Small to Medium Primary Choroidal Melanoma
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Group 1
Low dose Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Study treatment

Experimental: Group 2
Medium dose Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Study treatment

Experimental: Group 3
High dose Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Study treatment

Experimental: Group 4
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
Drug: Light-activated AU-011
Study treatment

Experimental: Group 5
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Study treatment

Experimental: Group 6
High dose Light-activated AU-011 followed by two laser light applications
Drug: Light-activated AU-011
Study treatment

Experimental: Group 7
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
Drug: Light-activated AU-011
Study treatment

Experimental: Group 8
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Drug: Light-activated AU-011
Study treatment




Primary Outcome Measures :
  1. Safety of Light-activated AU-011 [ Time Frame: 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 [ Time Frame: Screening to various time points through Week 52 ]
    Anti-Drug Antibody analysis

  2. Preliminary efficacy [ Time Frame: Change from baseline at 3 months following treatment and at each visit through study completion (2 years) ]
    Tumor size measured by ultrasonography and fundus photography

  3. Preliminary efficacy [ Time Frame: Change from baseline at 3 months following treatment and at each visit through study completion (2 years) ]
    Changes in ETDRS best corrected visual acuity (BCVA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of choroidal melanoma

Exclusion Criteria:

  • Have known contraindications or sensitivities to the study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052127


Contacts
Contact: Rochelle M Summerfelt, MS (312) 613-6006 rsummerfelt@aurabiosciences.com
Contact: Denis O'Shaughnessy, PhD (917) 417-3974 denis@aurabiosciences.com

Locations
United States, California
UCLA Jules Stein Eye Institute Recruiting
Los Angeles, California, United States, 90095
United States, Colorado
Colorado Retina Associates Terminated
Denver, Colorado, United States, 80210
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
W. K. Kellogg Eye Center, University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Associated Retinal Consultants, PC Recruiting
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Retina Center Recruiting
Minneapolis, Minnesota, United States, 55404
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10027
United States, Pennsylvania
Wills Eye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Aura Biosciences
Investigators
Study Director: Denis O'Shaughnessy, PhD Aura Biosciences

Responsible Party: Aura Biosciences
ClinicalTrials.gov Identifier: NCT03052127     History of Changes
Other Study ID Numbers: AU-011-101
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aura Biosciences:
Uveal melanoma
Eye cancer
Ocular melanoma
Choroidal melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas