Clinical trial

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

Aliases

AU-011-202, NCT04417530

Name

AU-011-202

Description

The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

Trial arms

Trial start

2020-08-05

Estimated PCD

2024-04-22

Trial end

2024-04-22

Status

Completed

Phase

Early phase I

Treatment

AU-011

AU-011 Via Suprachoroidal Administration with laser treatment

Arms:

Cohort 1 AU-011 & Laser, Cohort 2 AU-011 & Laser, Cohort 3 AU-011 & Laser, Cohort 4 AU-011 & Laser, Cohort 5 AU-011 & Laser, Cohort 6 AU-011 & Laser

Suprachoroidal Microinjector

Suprachoroidal Injection Device

Arms:

Cohort 1 AU-011 & Laser, Cohort 2 AU-011 & Laser, Cohort 3 AU-011 & Laser, Cohort 4 AU-011 & Laser, Cohort 5 AU-011 & Laser, Cohort 6 AU-011 & Laser

PDT Laser

Laser Administration

Arms:

Cohort 1 AU-011 & Laser, Cohort 2 AU-011 & Laser, Cohort 3 AU-011 & Laser, Cohort 4 AU-011 & Laser, Cohort 5 AU-011 & Laser, Cohort 6 AU-011 & Laser

Size

Primary endpoint

Treatment related AEs and treatment related serious adverse events (SAEs).

52 weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

Updated at

2024-08-21

1 organization

Organization

Aura Biosciences