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Completed

NCT Number: NCT04417530

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

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).

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Key information

Conditions

Uveal Melanoma Choroidal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ocular Melanoma Uveal Diseases Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retina Associates SW, P.C., Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AU-011

Drug

AU-011 Via Suprachoroidal Administration

Suprachoroidal Microinjector

Device

Suprachoroidal Injection Device

PDT Laser

Device

Laser Administration

Primary outcomes

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

    Time frame: 52 weeks

    Adverse Events

Secondary outcomes

  1. Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.

    Time frame: 52 weeks

    Tumor Thickness Growth Rate

  2. Time to reach tumor progression

    Time frame: 52 weeks

    Tumor progression

Sponsors and collaborators

Lead sponsor

Aura Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2020
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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