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 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
1 other identifier
interventional
22
1 country
22
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2020
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedStudy Start
First participant enrolled
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2024
CompletedMarch 3, 2025
February 1, 2025
3.7 years
June 2, 2020
February 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment related AEs and treatment related serious adverse events (SAEs).
Adverse Events
52 weeks
Secondary Outcomes (2)
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
52 weeks
Time to reach tumor progression
52 weeks
Study Arms (6)
Cohort 1 AU-011& Laser
EXPERIMENTALLow dose of AU-011 + 1 laser application
Cohort 2 AU-011 & Laser
EXPERIMENTALMedium dose of AU-011 + 1 laser application
Cohort 3 AU-011 (belzupacap sarotalocan) & Laser
EXPERIMENTALMedium dose of AU-011 + 2 laser applications
Cohort 4 AU-011 & Laser
EXPERIMENTALHighest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Cohort 5 AU-011 & Laser
EXPERIMENTALAU-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
EXPERIMENTALHigh dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
Interventions
AU-011 Via Suprachoroidal Administration
Suprachoroidal Injection Device
Laser Administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aura Bioscienceslead
Study Sites (22)
Retina Associates SW, P.C.
Tucson, Arizona, 85710, United States
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095, United States
Byers Eye Institute at Stanford University
Palo Alto, California, 94303, United States
UCHealth Eye Center
Aurora, Colorado, 80045, United States
Retina Associates of Florida
Tampa, Florida, 33609, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
University of Illinois At Chicago Illinois Eye and Ear Infirmary
Chicago, Illinois, 60612, United States
Midwest Eye Institute
Carmel, Indiana, 46290, United States
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, Iowa, 52242, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105, United States
Associated Retinal Consultants, PC
Royal Oak, Michigan, 48073, United States
Retina Center
Minneapolis, Minnesota, 55404, United States
Columbia University Medical Center
New York, New York, 10027, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, 97239, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Retina Consultants of Carolina, PA
Greenville, South Carolina, 29605, United States
St. Thomas Health / Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
University of Wisconsin Dept of Ophthalmology & Visual Sciences
Madison, Wisconsin, 53705, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Aura Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2020
First Posted
June 4, 2020
Study Start
August 5, 2020
Primary Completion
April 22, 2024
Study Completion
April 22, 2024
Last Updated
March 3, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share