Brief Title
Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Official Title
A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Brief Summary
The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.
Detailed Description
A Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation Phase (Open-label, Ascending Single and Repeat Dose) and a Randomized, Masked Confirmatory Phase Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Treatment related AEs and treatment related serious adverse events (SAEs).
Secondary Outcome
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
Condition
Uveal Melanoma
Intervention
AU-011
Study Arms / Comparison Groups
Cohort 1 AU-011 & Laser
Description: Low dose of AU-011 + 1 laser 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
22
Start Date
August 5, 2020
Completion Date
September 30, 2024
Primary Completion Date
September 30, 2023
Eligibility Criteria
Inclusion Criteria: - Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) - Have no evidence of metastatic disease confirmed by imaging - Be treatment naïve for IL/CM Exclusion Criteria: - Have known contraindications or sensitivities to the study drug or laser - Active ocular disease
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, 617-500-8864, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04417530
Organization ID
AU-011-202
Responsible Party
Sponsor
Study Sponsor
Aura Biosciences
Study Sponsor
Medical Monitor, Study Director, Aura Biosciences
Verification Date
November 2022