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NCT Number: NCT06007690

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Choroidal Melanoma Eye Diseases Eye Neoplasms Indeterminate Lesions 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 Melanoma Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye Research Australia, East Melbourne, Victoria, Australia

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About this study

This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.

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 naive for IL/CM (subjects who received PDT may be eligible)

Exclusion criteria

  • Have known contraindications or sensitivities to the study drug or laser
  • Active ocular infection or disease

Treatment and study plan

Bel-sar

Drug

Bel-sar via suprachoroidal administration followed by laser application.

Other names: AU-011

Suprachoroidal Microinjector

Device

Suprachoroidal injection device

Other names: SCS Microinjector

Infrared Laser

Device

Laser application

Sham Infrared Laser

Device

Sham laser application

Sham Microinjector

Device

Sham injection device

Primary outcomes

  1. Time to reach tumor progression

    Time frame: 65 weeks

    Tumor Progression

Secondary outcomes

  1. Time to composite endpoint

    Time frame: 65 weeks

    Tumor progression or visual acuity failure

Sponsors and collaborators

Lead sponsor

Aura Biosciences

Industry

Registry information

Acronym: CoMpass

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 23, 2023
Registry last updated
Jul 31, 2026

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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