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 Information
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
Administrative Informations
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