Study in Subjects With Small Primary Choroidal Melanoma

Uveal Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052127
• Other study ID #: AU-011-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 27, 2017
• Est. completion date: January 26, 2021

Study information

• Verified date: January 2024
• Source: Aura Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 26, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of choroidal melanoma

Exclusion Criteria:

• Have known contraindications or sensitivities to the study drug

Related Conditions & MeSH terms

• Choroidal Melanoma
• Melanoma
• Ocular Melanoma
• Uveal Melanoma

Intervention

Drug:
• Light-activated AU-011
Study treatment

Device:
• Laser Activation
Study treatment

Locations

Country	Name	City	State
United States	W. K. Kellogg Eye Center, University of Michigan	Ann Arbor	Michigan
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	Colorado Retina Associates	Denver	Colorado
United States	Retina Consultants of Carolina, PA	Greenville	South Carolina
United States	Retina Consultants of Houston	Houston	Texas
United States	UCLA Jules Stein Eye Institute	Los Angeles	California
United States	Retina Center	Minneapolis	Minnesota
United States	Columbia University Medical Center	New York	New York
United States	Byers Eye Institute at Stanford University	Palo Alto	California
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Associated Retinal Consultants, PC	Royal Oak	Michigan
United States	Retina Consultants of Sacramento	Sacramento	California
United States	Retina Associates SW, P.C.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Aura Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Informed consent through 1-2 years
Secondary	Immunogenicity (Anti-AU-011 Antibody Analysis)	Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)	Screening to various time points through 24 months
Secondary	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.	Change from baseline following treatment and at each subsequent visit through Week 52
Secondary	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.	Change from baseline following treatment and at each subsequent visit through Week 52
Secondary	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.	Change from baseline following treatment and at each subsequent visit through Week 52