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Virus Therapy

AU-011 for Eye Melanoma

Phase 2
Waitlist Available
Research Sponsored by Aura Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have no evidence of metastatic disease confirmed by imaging
Be treatment naïve for IL/CM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial is testing a new treatment for small choroidal melanoma. The treatment is an injection into the suprachoroidal space and the primary objective is to assess the safety and efficacy of this new treatment.

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 any previous treatments for these conditions and have no signs of the cancer spreading to other parts of the body. People can't join if they are allergic or sensitive to the study drug or laser treatment, or if they have an active eye disease.Check my eligibility
What is being tested?
The trial is testing belzupacap sarotalocan (AU-011) delivered into the eye using a special microinjector followed by PDT laser treatment. The goal is to see how safe and effective this approach is in treating small tumors in the eye related to melanoma.See study design
What are the potential side effects?
Potential side effects may include discomfort at injection site, inflammation inside the eye, changes in vision, and sensitivity to light due to AU-011 and PDT laser therapy. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My scans show no signs of cancer spread.
Select...
I have not received any treatments for my condition.
Select...
I have been diagnosed with a small eye melanoma or an uncertain eye lesion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment related AEs and treatment related serious adverse events (SAEs).
Secondary outcome measures
Time to reach tumor progression
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort 6 AU-011 & LaserExperimental Treatment3 Interventions
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
Group II: Cohort 5 AU-011 & LaserExperimental Treatment3 Interventions
AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
Group III: Cohort 4 AU-011 & LaserExperimental Treatment3 Interventions
Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Group IV: Cohort 3 AU-011 & LaserExperimental Treatment3 Interventions
Medium dose of AU-011 + 2 laser applications
Group V: Cohort 2 AU-011 & LaserExperimental Treatment3 Interventions
Medium dose of AU-011 + 1 laser application
Group VI: Cohort 1 AU-011 & LaserExperimental Treatment3 Interventions
Low dose of AU-011 + 1 laser application

Find a Location

Who is running the clinical trial?

Aura BiosciencesLead Sponsor
5 Previous Clinical Trials
680 Total Patients Enrolled
4 Trials studying Choroidal Melanoma
659 Patients Enrolled for Choroidal Melanoma
Medical MonitorStudy DirectorAura Biosciences
1,649 Previous Clinical Trials
979,836 Total Patients Enrolled
3 Trials studying Choroidal Melanoma
602 Patients Enrolled for Choroidal Melanoma
Abhijit Narvekar, MBBSStudy DirectorAura Biosciences
1 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Choroidal Melanoma
57 Patients Enrolled for Choroidal Melanoma

Media Library

AU-011 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04417530 — Phase 2
Choroidal Melanoma Research Study Groups: Cohort 1 AU-011 & Laser, Cohort 2 AU-011 & Laser, Cohort 3 AU-011 & Laser, Cohort 4 AU-011 & Laser, Cohort 5 AU-011 & Laser, Cohort 6 AU-011 & Laser
Choroidal Melanoma Clinical Trial 2023: AU-011 Highlights & Side Effects. Trial Name: NCT04417530 — Phase 2
AU-011 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04417530 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the likelihood of serious side effects from AU-011?

"AU-011's efficacy has not yet been clinically proven, however, there is some data supporting safety, warranting a score of 2."

Answered by AI

Are there different sites where this research is being conducted?

"For this study, there are a total of 21 enrolling patients from locations such as UCHealth Eye Center in Aurora, Retina Center in Minneapolis, and University of Illinois At Chicago Illinois Eye and Ear Infirmary in Chicago."

Answered by AI

How many research subjects are being accepted into this trial?

"The sponsor, Aura Biosciences, needs to recruit 58 patients that meet the inclusion criteria from multiple sites in order to proceed with the study. Some of these locations include UCHealth Eye Center in Aurora, Colorado and Retina Center in Minneapolis, Minnesota."

Answered by AI
~0 spots leftby May 2024