What side effects are associated with this type of intervention?

Targeted therapies like Belzupacap Sarotalocan, which bind to cancer cells and deliver cytotoxic agents, commonly exhibit side effects such as local inflammation, pain at the injection site, and potential damage to surrounding healthy tissues. Systemic side effects may include fatigue, nausea, and immune reactions. These treatments aim to minimize damage to non-cancerous cells, but some off-target effects can still occur, leading to mild to moderate adverse events.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments of Indeterminate Lesions (IL) using targeted therapies similar to Belzupacap Sarotalocan (bel-sar). However, targeted therapies that bind to cancer cells and deliver cytotoxic agents have been approved for other types of cancers. For example, antibody-drug conjugates (ADCs) like Trastuzumab emtansine (Kadcyla) for HER2-positive breast cancer and Brentuximab vedotin (Adcetris) for Hodgkin lymphoma and systemic anaplastic large cell lymphoma are notable examples. These therapies work by specifically targeting cancer cells and delivering a cytotoxic payload, similar to the mechanism of action of bel-sar.

What other types of research exist?

Promising novel alternatives to Belzupacap Sarotalocan for Indeterminate Lesions patients include: 1) Regorafenib, a multitargeted kinase inhibitor with demonstrated activity in various cancers, including osteosarcoma. 2) Pembrolizumab, an immune checkpoint inhibitor that has shown efficacy in multiple cancer types, including sarcomas. 3) Avelumab, another immune checkpoint inhibitor targeting PD-L1, which has shown durable responses in mesothelioma and other cancers. These therapies are in advanced clinical trials or have been recently approved for related conditions and may offer potential benefits for IL patients.

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Virus Therapy

Belzupacap Sarotalocan for Eye Melanoma (CoMpass Trial)

Phase 3

Recruiting

Research Sponsored by Aura Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)

Have no evidence of metastatic disease confirmed by imaging

Must not have

Active ocular infection or disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 65 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests the safety and effectiveness of bel-sar, a drug injected into the eye and activated by a laser, in patients with specific eye conditions like IL or small CM.

Who is the study for?

This trial is for individuals with a clinical diagnosis of primary indeterminate lesions or small choroidal melanoma, who haven't had treatment for these conditions yet (except possibly PDT), and have no signs of the cancer spreading elsewhere in the body.

What is being tested?

The study is testing the safety and effectiveness of a new treatment called belzupacap sarotalocan using a special microinjector and infrared laser. Participants will be randomly assigned to either receive this new treatment or a sham (fake) procedure that mimics it without any active drug.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, eye inflammation, vision changes, or other reactions related to the drug or laser treatment. The exact side effects are being studied as part of this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a small eye melanoma or an uncertain eye lesion.

Select...

My scans show no signs of cancer spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an active eye infection or disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 65 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~65 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 65 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to reach tumor progression

Secondary study objectives

Time to composite endpoint

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low dose bel-sar treatment arm & laser applicationExperimental Treatment3 Interventions

Low dose of bel-sar + laser application

Group II: High dose bel-sar treatment arm & laser applicationExperimental Treatment3 Interventions

High dose of bel-sar + laser application

Group III: Sham control arm & sham laserPlacebo Group2 Interventions

Sham injection + sham laser

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Infrared Laser

2018

N/A

~10

Suprachoroidal Microinjector

2020

Completed Phase 2

~30

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Belzupacap Sarotalocan (bel-sar) is a targeted therapy that binds specifically to cancer cells and delivers a cytotoxic agent directly to them, minimizing damage to surrounding healthy tissue. This mechanism is crucial for patients with Indeterminate Lesions (IL) because it allows for precise targeting of potentially malignant cells, reducing the risk of progression to more severe forms of cancer while preserving vision and ocular health. Other common treatments for IL and small Choroidal Melanoma include laser therapy and radiation, which are less targeted and can affect surrounding healthy tissues, leading to more side effects. The precision of targeted therapies like bel-sar offers a significant advantage in managing IL effectively and safely.

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