Bel-sar for Eye Cancer

Recruiting at 8 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?

The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with choroidal metastasis from breast or lung primary tumors.

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 Bel-sar (AU-011) safe for humans?

Bel-sar (AU-011) is being studied for eye cancer treatment and has shown potential to target tumor cells specifically, which may help avoid some complications seen with other treatments. It is designed to induce an immune response against tumors, but detailed human safety data is still being gathered as it is under clinical investigation. ^{1 2 3 4 5}

How is the drug AU-011 unique for treating eye cancer?

AU-011 (belzupacap sarotalocan) is unique because it is a light-activated drug that specifically targets tumor cells in the eye, potentially avoiding the vision loss complications associated with traditional radiotherapy. It works by inducing rapid cell death and stimulating an immune response, which may also help treat distant tumors. ^{1 2 3 5 6}

What data supports the effectiveness of the drug AU-011 for treating eye cancer?

Research shows that AU-011, when activated by light, can kill tumor cells and trigger an immune response against the cancer. In animal studies, combining AU-011 with other immune therapies led to complete tumor responses, suggesting it could be effective for treating eye cancer. ^{1 3 5 6 7}

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: 160 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

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]

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 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]

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]

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]

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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes after Proton Beam Irradiation in Patients with Choroidal Melanoma Eligible for Investigational AU-011 Treatment. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Uveal melanoma therapy on the horizon? [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Ocular toxicity in BRAF mutant cutaneous melanoma patients treated with vemurafenib. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Selumetinib shows promise in metastatic uveal melanoma. [2018]

5. Germany 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. [2023]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Ocular Safety Profile of BRAF and MEK Inhibitors: Data from the World Health Organization Pharmacovigilance Database. [2021]