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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04417530

Enrollment

Registered

2020-06-04

Start date

2020-08-05

Completion date

2024-04-22

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma

Keywords

Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma

Brief summary

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).

Detailed 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.

Interventions

DRUGAU-011

AU-011 Via Suprachoroidal Administration

DEVICESuprachoroidal Microinjector

Suprachoroidal Injection Device

DEVICEPDT Laser

Laser Administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment related AEs and treatment related serious adverse events (SAEs).	52 weeks	Adverse Events

Secondary

Measure	Time frame	Description
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.	52 weeks	Tumor Thickness Growth Rate
Time to reach tumor progression	52 weeks	Tumor progression

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026