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NCT Number: NCT06643884

Suprachoroidal Administration in Subjects With Metastases to the Choroid

The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.

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Key information

Conditions

Eye Cancer Eye Diseases Eye Neoplasms Neoplasms Neoplasms by Site Primary Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Byers Eye Institute at Stanford University, Palo Alto, California, United States

Loading trial locations.

About this study

This is an open-label, dose escalation trial designed to assess safety and tolerability of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor.
  • Have at least one Metastases to the Choroid in the study eye

Exclusion criteria

  • Active ocular infection or disease.
  • Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy per the primary treating oncologist's assessment.
  • Must not be planning or expecting to switch/add systemic antineoplastic therapies during treatment

Treatment and study plan

AU-011

Drug

AU-011 Via Suprachoroidal Administration with laser treatment

SCS Microinjector

Device

Suprachoroidal Injection Device

laser

Device

Laser Administration

Primary outcomes

  1. Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.

    Time frame: 4 weeks after completion of treatment

    B-Scan Ultrasonography

  2. Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.

    Time frame: 4 weeks after completion of treatment

    Fundus photos

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Monitor

CONTACT

[email protected]

617-500-8864

Sponsors and collaborators

Lead sponsor

Aura Biosciences

Industry

Registry information

Official study title

A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in Subjects With Metastases to the Choroid

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 16, 2024
Registry last updated
Mar 13, 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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