Eye CancerPhase 2NCT06643884
Suprachoroidal Administration in Subjects With Metastases to the Choroid
A Phase 2 study testing AU-011, SCS Microinjector and Laser in people with Eye Cancer and Primary Cancer, run by Aura Biosciences at 13 sites in United States.
Trial summary
The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Cancer, Primary Cancer
- What is being tested?
- AU-011, SCS Microinjector and Laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 13 sitesUnited States
- Study dates
- 16 Dec 2024to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor.
- Have at least one Metastases to the Choroid in the study eye
Who cannot join
- Active ocular infection or disease.
- Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy where placement of the beam is likely to impact the study eye.
- Must not be planning or expecting to switch/add systemic antineoplastic therapies during treatment
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Kellogg Eye Center
Ann Arbor, Michigan, 48105
- Recruiting
Retina Consultants of Texas
Bellaire, Texas, 77401
- Recruiting
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
- Recruiting
Cleveland Clinic, Cole Eye Institute
Cleveland, Ohio, 44195
- Not yet recruiting
OH State Wexner Medical Center, Havener Eye Institute
Columbus, Ohio, 43212
- Not yet recruiting
Texas Retina Associates
Dallas, Texas, 75231
- Recruiting
Bascom Palmer Eye Institute
Miami, Florida, 33136
- Recruiting
Tennessee Retina, PC
Nashville, Tennessee, 37203
- Not yet recruiting
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, 73159
- Recruiting
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Not yet recruiting
Associated Retinal Consultants (ARC) PC
Royal Oak, Michigan, 48073
- Recruiting
University of Washington
Seattle, Washington, 98104
About this study
Official title: A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in Subjects With Metastases to the Choroid
The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
Read the detailed description
This is an open-label, dose escalation trial designed to assess safety and tolerability of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
- Conditions
- Eye Cancer, Primary Cancer
- Being tested
- AU-011, SCS Microinjector, Laser
- Keywords
- Choroidal Metastasis, Metastases to the Choroid, ocular, eye
- Medical subject headings
- Eye Neoplasms, 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 with laser treatment
SCS MicroinjectorDevice
Suprachoroidal Injection Device
LaserDevice
Laser Administration
| Study group | Role | What they receive |
|---|---|---|
| 80 micrograms of bel-sar | Experimental | 1 Cycle AU-011 with a dose of 80 micrograms Receives: Drug: AU-011; Device: SCS Microinjector; Device: Laser |
| 140 micrograms of bel-sar | Experimental | 1 Cycle AU-011 with a dose of 140 micrograms Receives: Drug: AU-011; Device: SCS Microinjector; Device: Laser |
| 200 micrograms of bel-sar with one cycle | Experimental | 1 Cycle AU-011 with a dose of 200 micrograms Receives: Drug: AU-011; Device: SCS Microinjector; Device: Laser |
| 200 micrograms of bel-sar with two cycles | Experimental | 2 Cycles AU-011 with a dose of 200 micrograms Receives: Drug: AU-011; Device: SCS Microinjector; Device: Laser |
| Observational | No 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. |
| 40 micrograms of bel-sar with one cycle | Experimental | 1 Cycle AU-011 with a dose of 40 micrograms Receives: Drug: AU-011; Device: SCS Microinjector; Device: Laser |
| 40 micrograms of bel-sar with two cycles | Experimental | 2 Cycles AU-011 with a dose of 40 micrograms Receives: Drug: AU-011; Device: SCS Microinjector; Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.
B-Scan Ultrasonography
Measured: 4 weeks after completion of treatment
Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.
Fundus photos
Measured: 4 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start16 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye CancerStudies 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
- 24 participants (estimated)
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
- NCT06643884
- Sponsor's protocol ID
- AU-011-203
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2024
- Last updated
- 8 Oct 2026
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in Subjects With Metastases to the Choroid
- ClinicalTrials.gov ID
- NCT06643884
- Acronym / sponsor ID
- AU-011-203
- Conditions
- Eye Cancer, Primary Cancer
- Keywords
- Choroidal Metastasis, Metastases to the Choroid, ocular, eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Aura BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 16 Oct 2024 (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 assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
Detailed description
This is an open-label, dose escalation trial designed to assess safety and tolerability of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 80 micrograms of bel-sar | Experimental | Drug: AU-011, Device: SCS Microinjector, Device: Laser1 Cycle AU-011 with a dose of 80 micrograms |
| 140 micrograms of bel-sar | Experimental | Drug: AU-011, Device: SCS Microinjector, Device: Laser1 Cycle AU-011 with a dose of 140 micrograms |
| 200 micrograms of bel-sar with one cycle | Experimental | Drug: AU-011, Device: SCS Microinjector, Device: Laser1 Cycle AU-011 with a dose of 200 micrograms |
| 200 micrograms of bel-sar with two cycles | Experimental | Drug: AU-011, Device: SCS Microinjector, Device: Laser2 Cycles AU-011 with a dose of 200 micrograms |
| Observational | No 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. |
| 40 micrograms of bel-sar with one cycle | Experimental | Drug: AU-011, Device: SCS Microinjector, Device: Laser1 Cycle AU-011 with a dose of 40 micrograms |
| 40 micrograms of bel-sar with two cycles | Experimental | Drug: AU-011, Device: SCS Microinjector, Device: Laser2 Cycles AU-011 with a dose of 40 micrograms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor.
- Have at least one Metastases to the Choroid in the study eye
Key exclusion criteria (3 listed)
- Active ocular infection or disease.
- Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy where placement of the beam is likely to impact the study eye.
- Must not be planning or expecting to switch/add systemic antineoplastic therapies during treatment
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 with laser treatment | Drug | 140 micrograms of bel-sar, 200 micrograms of bel-sar with one cycle, 200 micrograms of bel-sar with two cycles, 40 micrograms of bel-sar with one cycle, 40 micrograms of bel-sar with two cycles, 80 micrograms of bel-sar |
| SCS MicroinjectorSuprachoroidal Injection Device | Device | 140 micrograms of bel-sar, 200 micrograms of bel-sar with one cycle, 200 micrograms of bel-sar with two cycles, 40 micrograms of bel-sar with one cycle, 40 micrograms of bel-sar with two cycles, 80 micrograms of bel-sar |
| LaserLaser Administration | Device | 140 micrograms of bel-sar, 200 micrograms of bel-sar with one cycle, 200 micrograms of bel-sar with two cycles, 40 micrograms of bel-sar with one cycle, 40 micrograms of bel-sar with two cycles, 80 micrograms of bel-sar |
Primary outcome
Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.
Time frame: 4 weeks after completion of treatment
B-Scan Ultrasonography
Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.
Time frame: 4 weeks after completion of treatment
Fundus photos
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
Medical Monitor study director
Aura Biosciences
13 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, SCS Microinjector and Laser in people with Eye Cancer and Primary Cancer, run by Aura Biosciences at 13 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Monitor (617-500-8864, clinical@aurabiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment. (time frame: 4 weeks after completion of treatment). The study lists 2 primary outcomes in all. 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 8 Oct 2026.