Study in Subjects With Small Primary Choroidal Melanoma

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of choroidal melanoma

Exclusion Criteria

  • Have known contraindications or sensitivities to the study drug

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Rosaleen Ostrick
Phone: 310-794-5595
Email: ostrick@jsei.ucla.edu

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Aura Biosciences

Trial IDs

Primary ID AU-011-101
Secondary IDs NCI-2017-01535
Clinicaltrials.gov ID NCT03052127