Bel-sar for Eye Cancer

Recruiting at 9 trial locations

Overseen By Medical Monitor

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aura Biosciences

Disqualifiers: Ocular infection, Brain tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4-8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of a treatment called bel-sar (also known as AU-011) for individuals with eye cancer (choroidal metastases) that has spread from another part of the body. It evaluates different doses to determine the most effective one. Participants may qualify if they have cancer that has spread to the choroid, a part of the eye. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that bel-sar, also known as AU-011, is generally safe for patients. Earlier studies found bel-sar safe for most users. For patients with choroidal melanoma, a type of eye cancer, bel-sar controlled the tumor in 80% of cases and helped maintain clear vision for 90% of patients. This indicates it can treat the cancer while preserving vision without causing significant harm.

The studies reviewed reported no major side effects, meaning most people didn't experience serious problems from the treatment. The evidence suggests that bel-sar can be a safe option for patients, particularly for controlling eye tumors with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about bel-sar (AU-011) for eye cancer because it introduces a novel approach compared to standard treatments like radiation or surgery. Unlike these traditional methods, bel-sar leverages a unique mechanism involving a targeted viral nanoparticle designed to bind to cancer cells and destroy them with light activation. This precision-targeting could potentially minimize damage to surrounding healthy tissue, offering a less invasive and more focused treatment option. Additionally, the flexibility in dosing—ranging from 80 to 200 micrograms and offering one or two treatment cycles—may allow for personalized treatment plans tailored to individual patient needs.

What evidence suggests that this trial's treatments could be effective for eye cancer?

Research has shown that bel-sar, also known as AU-011, may help control tumors and protect vision in people with eye cancer. Studies found that bel-sar controlled tumors in 80% of cases and helped maintain vision in 90% of patients. This trial includes several treatment arms where participants receive different dosages of bel-sar—80 micrograms, 140 micrograms, or 200 micrograms—to evaluate its effectiveness and safety. The treatment works by attaching to specific parts of the tumor, helping to stop its growth. Previous research indicates that bel-sar is generally safe and well-tolerated by patients. These findings suggest that bel-sar could be an effective option for people with eye cancer, especially for preserving their vision. ^{2 3 6 7 8}

Who Is on the Research Team?

Medical Monitor

Principal Investigator

Aura Biosciences

Are You a Good Fit for This Trial?

This trial is for individuals with choroidal metastasis, which are cancerous growths in the eye that have spread from either breast or lung tumors. Participants must meet certain health standards to be eligible.

Inclusion Criteria

I have a diagnosis of eye cancer that originated from breast or lung cancer.

I have cancer spread to only one eye and not the other.

Exclusion Criteria

I have an active eye infection or disease.

I don't have brain tumors needing radiation according to my cancer doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1-2 cycles of bel-sar treatment with varying doses administered suprachoroidally

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AU-011

Trial Overview The study is testing the safety and tolerability of a treatment called bel-sar, administered through a special injection into the eye (suprachoroidal space), sometimes followed by laser treatment.

How Is the Trial Designed?

Group I: 80 micrograms of bel-sar Experimental Treatment 3 Interventions

1 Cycle AU-011 with a dose of 80 micrograms

Group II: 200 micrograms of bel-sar with two cycles Experimental Treatment 3 Interventions

2 Cycles AU-011 with a dose of 200 micrograms

Group III: 200 micrograms of bel-sar with one cycle Experimental Treatment 3 Interventions

1 Cycle AU-011 with a dose of 200 micrograms

Group IV: 140 micrograms of bel-sar Experimental Treatment 3 Interventions

1 Cycle AU-011 with a dose of 160 micrograms

Group V: Observational Active Control 1 Intervention

Subjects that meet trial inclusion, but do not meet criteria for enrollment into the bel-sar treatment cohorts, may be enrolled in this cohort. The observational cohort will not receive bel-sar treatment.

Who Is Running the Clinical Trial?

Aura Biosciences

Lead Sponsor

Trials

7

Recruited

730+

Published Research Related to This Trial

The drug belzupacap sarotalocan (AU-011) effectively induces immunogenic cell death in primary and metastatic uveal melanoma (UM) cell lines at very low concentrations (picomolar range), suggesting its potential as a targeted treatment.

AU-011 treatment was more effective in BAP1-positive UM cell lines, showing lower half-maximal effective concentration (EC50) values and higher exposure of damage-associated molecular patterns (DAMPs), which may enhance systemic immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Testing of the Virus-Like Drug Conjugate Belzupacap Sarotalocan (AU-011) on Uveal Melanoma Suggests BAP1-Related Immunostimulatory Capacity. Ma, S., Huis In't Veld, RV., Houy, A., et al.[2023]

In a review of clinical trials involving 855 patients with advanced melanoma, 22% of those treated with vemurafenib experienced ocular adverse effects, with uveitis being the most common at 4%.

Despite these ocular side effects, they were manageable, allowing patients to continue their vemurafenib treatment without interruption, indicating a level of safety in the management of these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular toxicity in BRAF mutant cutaneous melanoma patients treated with vemurafenib. Choe, CH., McArthur, GA., Caro, I., et al.[2022]

The phase II trial of the MEK inhibitor selumetinib shows promising results for patients with metastatic uveal melanoma, a rare and aggressive form of eye cancer.

This trial indicates that selumetinib may provide a new treatment option for patients facing this challenging diagnosis, highlighting its potential efficacy in combating this fatal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uveal melanoma therapy on the horizon? [2018]

In a study of 222 patients treated with proton beam irradiation (PBI) for small choroidal melanoma, over half experienced significant visual acuity loss (to 20/80 or worse) within 5 years, especially if tumors were near the optic disc or fovea.

The low rates of tumor recurrence (1.4%), neovascular glaucoma (4.5%), and eye loss (2.7%) suggest that while PBI is effective in controlling the tumor, it may not adequately preserve vision, highlighting the potential benefit of the investigational drug AU-011 for better vision outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after Proton Beam Irradiation in Patients with Choroidal Melanoma Eligible for Investigational AU-011 Treatment. Wu, F., Lane, AM., Trofimov, A., et al.[2023]

A study analyzing 1568 reported cases of ocular adverse effects (OAEs) from BRAF and MEK inhibitors found that BRAF monotherapy is significantly linked to various eye issues, including iris and ciliary body abnormalities and anterior uveitis, indicating a need for careful monitoring of these side effects.

MEK inhibitor monotherapy was associated with retinal and choroid abnormalities, and the combination therapy of BRAF and MEK inhibitors showed potential for increased ocular toxicity, suggesting that personalized management strategies are necessary for patients undergoing combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular Safety Profile of BRAF and MEK Inhibitors: Data from the World Health Organization Pharmacovigilance Database. Mettler, C., Monnet, D., Kramkimel, N., et al.[2021]

AU-011, a new virus-like drug conjugate, effectively induces necrotic cell death and triggers a strong anti-tumor immune response, making it a promising treatment for small choroidal melanoma and potentially distant tumors.

Combining AU-011 with checkpoint blockade antibodies, particularly anti-PD-L1 and anti-LAG-3, significantly enhances treatment efficacy, achieving complete tumor responses in about 75% of mice with established tumors, indicating its potential for broader cancer therapy applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibition combined with targeted therapy using a novel virus-like drug conjugate induces complete responses in a murine model of local and distant tumors. Huis In 't Veld, RV., Ma, S., Kines, RC., et al.[2023]

Citations

1. ir.aurabiosciences.com ir.aurabiosciences.com/news-releases/news-release-details/aura-biosciences-reports-positive-phase-2-end-study-results

Aura Biosciences Reports Positive Phase 2 End of Study ... Bel-sar demonstrated 80% tumor control rate, 90% visual acuity preservation, and a highly favorable safety profile.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10712974/

Proton Beam Irradiation Outcomes for Choroidal Melanoma Treatment with AU-011 may allow better vision preservation in small tumors that carry a high risk of vision loss with radiotherapy.

3. aurabiosciences.com aurabiosciences.com/wp-content/uploads/2021/07/Aura-Preclinical-Data-Presented-at-ARVO-2020_Final.pdf

AU-011 Ocular Distribution & Efficacy for Melanoma AU-011 is a highly tumor targeted investigational treatment for choroidal melanoma which is designed to selectively bind to specifically modified heparan ...

4. ophthalmologytimes.com ophthalmologytimes.com/view/aura-biosciences-reports-positive-phase-2-end-of-study-results-evaluating-au-011-for-early-stage-choroidal-melanoma

Retina Society 2024: Aura Biosciences AU-011 Phase 2 Results According to the company, it Phase 2 results showed that AU-011 achieved an 80% tumor control rate (n = 8/10) among Phase 3-eligible patients ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06007690

Study: Belzupacap Sarotalocan for Melanoma A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects ...

6. aurabiosciences.com aurabiosciences.com/companynews/aura-biosciences-presents-interim-phase-2-safety-data-evaluating-suprachoroidal-administration-of-au-011-in-patients-with-choroidal-melanoma-at-the-asrs-2021-annual-meeting/

Aura Biosciences Presents Interim Phase 2 Safety Data ... AU-011 for the treatment of choroidal melanoma is currently in Phase 2 clinical development and the company plans to expand the clinical program into choroidal ...

7. chiesiventures.com chiesiventures.com/aura-biosciences-announces-positive-interim-phase-2-safety-and-efficacy-data-of-belzupacap-sarotalocan-bel-sar-for-the-first-line-treatment-of-patients-with-early-stage-choroidal-melanoma-with-supra/

Aura Biosciences Announces Positive Interim Phase 2 ... These latest results strongly support the potential of bel-sar to be used as a first line treatment option for patients with early-stage choroidal melanoma.

8. columbusvp.com columbusvp.com/en/aura-biosciences-presents-updated-clinical-data-for-au-011/

Aura Biosciences presents updated clinical data for AU-011 In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety ...