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NCT06007690 Clinical Trial

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

Uveal Melanoma Clinical Trial

— CoMpass  

Official title:
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06007690
Other study ID # AU-011-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 6, 2023
Est. completion date March 1, 2027

Study information
Verified date May 2024
Source Aura Biosciences
Contact Medical Monitor
Phone 617-500-8864
Email clinical@aurabiosciences.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

Description:

This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 1, 2027
Est. primary completion date March 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) - Have no evidence of metastatic disease confirmed by imaging - Be treatment naive for IL/CM (subjects who received PDT may be eligible) Exclusion Criteria: - Have known contraindications or sensitivities to the study drug or laser - Active ocular infection or disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Belzupacap Sarotalocan
Bel-sar via suprachoroidal administration followed by laser application.
Device:
• Suprachoroidal Microinjector
Suprachoroidal injection device
• Infrared Laser
Laser application
• Sham Infrared Laser
Sham laser application
• Sham Microinjector
Sham injection device
Drug:
• Sham Treatment
Sham drug via sham injection followed by sham laser

Locations
Country Name City State
Australia Terrace Eye Centre Brisbane Queensland
Australia Eye Research Australia East Melbourne Victoria
United Kingdom Liverpool University Hospitals NHS Foundation Trust Broadgreen Hospital Liverpool England
United Kingdom Moorfields Eye Hospital at City Road London England
United Kingdom Nhs Foundation Trust - Royal Hallamshire Hospital Sheffield South Yorkshire
United States W.K. Kellogg Eye Center - University of Michigan Ann Arbor Michigan
United States Emory Eye Center Atlanta Georgia
United States Austin Retina Associates Austin Texas
United States Vitreoretinal Associates of Washington Bellevue Washington
United States Retina Consultants of Alabama Birmingham Alabama
United States Massachusetts Eye and Ear Boston Massachusetts
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States University of Illinois at Chicago Chicago Illinois
United States Cole Eye Institute Cleveland Ohio
United States Ohio State Ophthalmic Oncology Service Columbus Ohio
United States Texas Retina Associates Dallas Texas
United States UT, Southwestern Medical Center Dallas Texas
United States Duke Eye Center Durham North Carolina
United States Retina Consultants of Carolina Greenville South Carolina
United States UCSD Shiley Eye Institute, Jacobs Retina Center La Jolla California
United States Colorado Retina Associates Lakewood Colorado
United States University of Wisconsin Madison Madison Wisconsin
United States University of Tennessee Hamilton Eye Institute Memphis Tennessee
United States Tennessee Retina, PC Nashville Tennessee
United States Dean McGee Eye Institute Oklahoma City Oklahoma
United States Nebraska Medicine's Truhlsen Eye Institute Omaha Nebraska
United States Stanford University School of Medicine Palo Alto California
United States Thomas Jefferson University (TJU) - Wills Eye Institute Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States University of Rochester, Flaum Eye Institute Rochester New York
United States Associated Retinal Consultants (ARC) P.C. Royal Oak Michigan
United States Retinal Consultants Medical Group, Inc. Sacramento California
United States Retina Associates of Utah Salt Lake City Utah
United States Retina Associates of South Texas, P.A. San Antonio Texas
United States University of Washington Medical Center Seattle Washington
United States Retina Center of Texas Southlake Texas
United States Retina Associates of Florida, PA Tampa Florida
United States Retina Consultants of Texas The Woodlands Texas

Sponsors (1)
Lead Sponsor Collaborator
Aura Biosciences

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to reach tumor progression Tumor Progression 52 weeks
Secondary Time to composite endpoint Tumor progression or visual acuity failure 52 weeks
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Active, not recruiting NCT02913417 - Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases Phase 1/Phase 2
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