Study in Subjects With Small Primary Choroidal Melanoma

Brief Title

Study in Subjects With Small Primary Choroidal Melanoma

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

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.
    

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 Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011

Secondary Outcome

 Immunogenicity

Condition

Uveal Melanoma

Intervention

Light-activated AU-011

Study Arms / Comparison Groups

 Single Low Dose Light-activated AU-011

Description:  Low dose Light-activated AU-011 followed by a single laser light application

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

57

Start Date

February 27, 2017

Completion Date

January 26, 2021

Primary Completion Date

January 26, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of choroidal melanoma

        Exclusion Criteria:

          -  Have known contraindications or sensitivities to the study drug
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Abhijit Narvekar, MBBS, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT03052127

Organization ID

AU-011-101

Responsible Party

Sponsor

Study Sponsor

Aura Biosciences

Study Sponsor

Abhijit Narvekar, MBBS, Study Director, Aura Biosciences

Verification Date

January 2022