Study in Subjects With Small Primary Choroidal Melanoma

Aura Biosciences57 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uveal Melanoma Ocular Melanoma Choroidal Melanoma

Interventions

Light-activated AU-011DRUG

Study treatment

Laser ActivationDEVICE

Study treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of choroidal melanoma Exclusion Criteria: * Have known contraindications or sensitivities to the study drug

Locations (13)

Retina Associates SW, P.C.

Tucson, Arizona, United States

UCLA Jules Stein Eye Institute

Los Angeles, California, United States

Byers Eye Institute at Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011

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

Time frame: Informed consent through 1-2 years

Secondary Outcomes

Immunogenicity (Anti-AU-011 Antibody Analysis)

Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)

Time frame: Screening to various time points through 24 months

Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]

Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.

Time frame: Change from baseline following treatment and at each subsequent visit through Week 52

Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]

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.

Time frame: 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

Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.

Time frame: Change from baseline following treatment and at each subsequent visit through Week 52

Data from ClinicalTrials.gov

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