Uveal MelanomaPhase 2NCT04417530
Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
A Phase 2 study testing AU-011, Suprachoroidal Microinjector and PDT Laser in people with Uveal Melanoma and Ocular Melanoma, run by Aura Biosciences at 22 sites in United States.
Trial summary
The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma
- What is being tested?
- AU-011, Suprachoroidal Microinjector and PDT Laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 22 sitesUnited States
- Study dates
- 5 Aug 2020to 22 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- Have no evidence of metastatic disease confirmed by imaging
- Be treatment naïve for IL/CM
Who cannot join
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular disease
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105
Emory Eye Center
Atlanta, Georgia, 30322
UCHealth Eye Center
Aurora, Colorado, 80045
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Midwest Eye Institute
Carmel, Indiana, 46290
University of Illinois At Chicago Illinois Eye and Ear Infirmary
Chicago, Illinois, 60612
Texas Retina Associates
Dallas, Texas, 75231
Retina Consultants of Carolina, PA
Greenville, South Carolina, 29605
Retina Consultants of Houston
Houston, Texas, 77030
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, Iowa, 52242
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095
University of Wisconsin Dept of Ophthalmology & Visual Sciences
Madison, Wisconsin, 53705
Retina Center
Minneapolis, Minnesota, 55404
St. Thomas Health / Tennessee Retina, PC
Nashville, Tennessee, 37203
Columbia University Medical Center
New York, New York, 10027
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, 97239
Associated Retinal Consultants, PC
Royal Oak, Michigan, 48073
Retina Associates of Florida
Tampa, Florida, 33609
Retina Associates SW, P.C.
Tucson, Arizona, 85710
About this study
Official title: A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
Read the detailed description
This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.
- Conditions
- Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma
- Being tested
- AU-011, Suprachoroidal Microinjector, PDT Laser
- Keywords
- Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma
- Medical subject headings
- Uveal Melanoma, Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AU-011Drug
AU-011 Via Suprachoroidal Administration
Suprachoroidal MicroinjectorDevice
Suprachoroidal Injection Device
PDT LaserDevice
Laser Administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 AU-011& Laser | Experimental | Low dose of AU-011 + 1 laser application Receives: Drug: AU-011; Device: Suprachoroidal Microinjector; Device: PDT Laser |
| Cohort 2 AU-011 & Laser | Experimental | Medium dose of AU-011 + 1 laser application Receives: Drug: AU-011; Device: Suprachoroidal Microinjector; Device: PDT Laser |
| Cohort 3 AU-011 (belzupacap sarotalocan) & Laser | Experimental | Medium dose of AU-011 + 2 laser applications Receives: Drug: AU-011; Device: Suprachoroidal Microinjector; Device: PDT Laser |
| Cohort 4 AU-011 & Laser | Experimental | Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments Receives: Drug: AU-011; Device: Suprachoroidal Microinjector; Device: PDT Laser |
| Cohort 5 AU-011 & Laser | Experimental | 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. Receives: Drug: AU-011; Device: Suprachoroidal Microinjector; Device: PDT Laser |
| Cohort 6 AU-011 & Laser | Experimental | High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment. Receives: Drug: AU-011; Device: Suprachoroidal Microinjector; Device: PDT Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related AEs and treatment related serious adverse events (SAEs).
Adverse Events
Measured: 52 weeks
Secondary outcomes (2)
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
Tumor Thickness Growth Rate
Measured: 52 weeks
Time to reach tumor progression
Tumor progression
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start5 Aug 2020
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aura Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Aura Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417530
- Sponsor's protocol ID
- AU-011-202
- Status last verified
- Feb 2025
- First submitted
- 2 Jun 2020
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
- ClinicalTrials.gov ID
- NCT04417530
- Acronym / sponsor ID
- AU-011-202
- Conditions
- Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma
- Keywords
- Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Aura BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
Detailed description
This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 AU-011& Laser | Experimental | Drug: AU-011, Device: Suprachoroidal Microinjector, Device: PDT LaserLow dose of AU-011 + 1 laser application |
| Cohort 2 AU-011 & Laser | Experimental | Drug: AU-011, Device: Suprachoroidal Microinjector, Device: PDT LaserMedium dose of AU-011 + 1 laser application |
| Cohort 3 AU-011 (belzupacap sarotalocan) & Laser | Experimental | Drug: AU-011, Device: Suprachoroidal Microinjector, Device: PDT LaserMedium dose of AU-011 + 2 laser applications |
| Cohort 4 AU-011 & Laser | Experimental | Drug: AU-011, Device: Suprachoroidal Microinjector, Device: PDT LaserHighest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments |
| Cohort 5 AU-011 & Laser | Experimental | Drug: AU-011, Device: Suprachoroidal Microinjector, Device: PDT LaserAU-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. |
| Cohort 6 AU-011 & Laser | Experimental | Drug: AU-011, Device: Suprachoroidal Microinjector, Device: PDT LaserHigh dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- Have no evidence of metastatic disease confirmed by imaging
- Be treatment naïve for IL/CM
Key exclusion criteria (2 listed)
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AU-011AU-011 Via Suprachoroidal Administration | Drug | Cohort 1 AU-011& Laser, Cohort 2 AU-011 & Laser, Cohort 3 AU-011 (belzupacap sarotalocan) & Laser, Cohort 4 AU-011 & Laser, Cohort 5 AU-011 & Laser, Cohort 6 AU-011 & Laser |
| Suprachoroidal MicroinjectorSuprachoroidal Injection Device | Device | Cohort 1 AU-011& Laser, Cohort 2 AU-011 & Laser, Cohort 3 AU-011 (belzupacap sarotalocan) & Laser, Cohort 4 AU-011 & Laser, Cohort 5 AU-011 & Laser, Cohort 6 AU-011 & Laser |
| PDT LaserLaser Administration | Device | Cohort 1 AU-011& Laser, Cohort 2 AU-011 & Laser, Cohort 3 AU-011 (belzupacap sarotalocan) & Laser, Cohort 4 AU-011 & Laser, Cohort 5 AU-011 & Laser, Cohort 6 AU-011 & Laser |
Primary outcome
Treatment related AEs and treatment related serious adverse events (SAEs).
Time frame: 52 weeks
Adverse Events
2 secondary outcomes
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
Time frame: 52 weeks
Time to reach tumor progression
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Aura BiosciencesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Aura Biosciences
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AU-011, Suprachoroidal Microinjector and PDT Laser in people with Uveal Melanoma and Ocular Melanoma, run by Aura Biosciences at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related AEs and treatment related serious adverse events (SAEs). (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.