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Study on the Effectiveness and Safety of Belzupacap Sarotalocan for Patients with Small Choroidal Melanoma or Indeterminate Lesions

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Primary Indeterminate Lesions or Small Choroidal Melanoma, which are conditions affecting the eye. The treatment being tested is called Belzupacap Sarotalocan, also known by its code name AU-011. This medication is administered as a solution for injection using a special device called the Clearside SCS Microinjector, which delivers the medication into a specific part of the eye known as the suprachoroidal space.

The purpose of this study is to evaluate the effectiveness and safety of Belzupacap Sarotalocan compared to a placebo, which is a sham injection that does not contain the active medication. Participants in the study will receive either the active treatment or the placebo. The study will monitor the participants over a period to assess how the treatment affects the progression of the eye condition.

Throughout the study, participants will undergo regular check-ups to track the condition of their eye and overall health. The study aims to determine how well the treatment works in slowing down or stopping the growth of the lesions or melanoma, as well as ensuring that it is safe for use. The trial is expected to continue until 2027, with recruitment starting in 2024.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is randomly assigned to receive either the belzupacap sarotalocan treatment or a placebo. The assignment is masked, meaning neither the patient nor the healthcare providers know which treatment is being administered.

  2. Step 2

    Treatment administration

    The treatment involves the administration of belzupacap sarotalocan as a solution for injection. The injection is given through the suprachoroidal route, which is a method of delivering medication to the back of the eye.

    If assigned to the placebo group, the patient receives a sham injection, which contains no active medication.

  3. Step 3

    Monitoring and follow-up

    The patient is monitored regularly to assess the efficacy and safety of the treatment. This includes checking for any changes in the size of the tumor and evaluating visual acuity.

    The primary endpoint of the study is the time it takes for the tumor to progress, which is analyzed at Week 65. Secondary endpoints include a composite measure of tumor progression or visual acuity failure, also assessed at Week 65.

  4. Step 4

    Completion of the study

    The study is estimated to conclude by January 1, 2027. Throughout the study, the patient's health and response to the treatment are closely monitored to ensure safety and gather data on the treatment's effectiveness.

Who can join the trial?

5 criteria

  • Have a clinical diagnosis of primary indeterminate lesion or small choroidal melanoma with documented early growth. This means the patient has been diagnosed with a specific type of eye condition that is either uncertain or a small tumor in the eye, and there is proof that it has started to grow.
  • Have no evidence of metastatic disease confirmed by imaging. This means that tests, like scans, show that the disease has not spread to other parts of the body.
  • Be treatment naïve for their IL/CM. This means the patient has not received any treatment for their eye condition before. However, if they had a treatment called photodynamic therapy more than 12 months ago, they might still be eligible, but this needs to be discussed with a medical expert first.
  • Both male and female patients can participate.
  • Patients from vulnerable populations are also considered for participation.

Who cannot join the trial?

7 criteria

  • Patients with other eye diseases that could affect the study results.
  • Patients who have had previous treatments for eye tumors.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients with uncontrolled medical conditions that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

Belzupacap Sarotalocan (AU-011) is a medication being studied for its effectiveness and safety in treating primary indeterminate lesions and small choroidal melanoma, which are conditions affecting the eye. This medication is designed to target and destroy cancerous cells in the eye while sparing healthy tissue, potentially offering a new treatment option for patients with these specific eye conditions.

What is already known about the treatment

Belzupacap Sarotalocan – This medication is administered through an injection directly into the eye, specifically targeting the affected area. It is currently being evaluated in clinical trials for its effectiveness and safety in treating primary indeterminate lesions or small choroidal melanoma. The main therapeutic indication is for eye conditions that could potentially develop into more serious forms of melanoma. At the molecular level, it works by binding to cancer cells and using light activation to destroy them, a process known as photodynamic therapy. It is classified pharmacologically as a targeted cancer therapy.

Investigated diseases

Primary Indeterminate Lesions or Small Choroidal Melanoma – This condition involves abnormal growths in the eye, specifically in the choroid, which is a layer of blood vessels between the retina and the sclera. These lesions are termed "indeterminate" because it is unclear whether they are benign or malignant. Small choroidal melanoma is a type of cancer that originates in the choroid and is characterized by its small size. The progression of this disease can lead to changes in the size and shape of the lesions, potentially affecting vision. Over time, these lesions may grow, leading to further complications within the eye. Monitoring is essential to determine if the lesions remain stable or progress to a more serious condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504655-27-00Protocol codeAU-011-301Estimated enrolment204 patientsSponsorAura Biosciences Inc.

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