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
Verified date | January 2024 |
Source | Aura Biosciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Aura Biosciences |
United States,
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 |
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