Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Aura Biosciences

Status and phase

Completed

Phase 2

Conditions

Ocular Melanoma

Choroidal Melanoma

Uveal Melanoma

Treatments

Drug: AU-011

Device: Suprachoroidal Microinjector

Device: PDT Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT04417530

AU-011-202

Details and patient eligibility

About

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).

Full description

This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

22 participants in 6 patient groups

Cohort 1 AU-011 & Laser

Experimental group

Description:

Low dose of AU-011 + 1 laser application

Treatment:

Device: PDT Laser

Device: Suprachoroidal Microinjector

Drug: AU-011

Cohort 2 AU-011 & Laser

Experimental group

Description:

Medium dose of AU-011 + 1 laser application

Treatment:

Device: PDT Laser

Device: Suprachoroidal Microinjector

Drug: AU-011

Cohort 3 AU-011 & Laser

Experimental group

Description:

Medium dose of AU-011 + 2 laser applications

Treatment:

Device: PDT Laser

Device: Suprachoroidal Microinjector

Drug: AU-011

Cohort 4 AU-011 & Laser

Experimental group

Description:

Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments

Treatment:

Device: PDT Laser

Device: Suprachoroidal Microinjector

Drug: AU-011

Cohort 5 AU-011 & Laser

Experimental group

Description:

AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.

Treatment:

Device: PDT Laser

Device: Suprachoroidal Microinjector

Drug: AU-011

Cohort 6 AU-011 & Laser

Experimental group

Description:

High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.

Treatment:

Device: PDT Laser

Device: Suprachoroidal Microinjector

Drug: AU-011