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Clinical Trials in the USA / NCT06007690
Active, not recruiting Phase 3

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

NCT06007690 · tracked via the Priya Life Science USA tracker
Sponsor
Aura Biosciences
Phase
Phase 3
Started
2023-12-06
Last updated
2026-10-13

Condition(s) studied

Choroidal MelanomaIndeterminate LesionsUveal MelanomaOcular Melanoma

Investigational drug(s) / intervention(s)

Bel-sar →Suprachoroidal MicroinjectorInfrared LaserSham Infrared LaserSham Microinjector

Bel-sar: Bel-sar via suprachoroidal administration followed by laser application.

Suprachoroidal Microinjector: Suprachoroidal injection device

Infrared Laser: Laser application

Sham Infrared Laser: Sham laser application

Sham Microinjector: Sham injection device

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to reach tumor progression — 65 weeks
    Tumor Progression

Trial sites (53)

FacilityCityRegionStatus
Doris Stein Eye Research Center Los Angeles California
Stanford University School of Medicine Palo Alto California
Retinal Consultants Medical Group, Inc. Sacramento California
Emory Eye Center Atlanta Georgia
University of Illinois at Chicago Chicago Illinois
Tufts Medical Center New England Eye Center Boston Massachusetts
Massachusetts Eye and Ear Boston Massachusetts
W.K. Kellogg Eye Center - University of Michigan Ann Arbor Michigan
Associated Retinal Consultants (ARC) P.C. Royal Oak Michigan
Mayo Clinic Rochester Minnesota
Columbia University Irving Medical Center New York New York
Cole Eye Institute Cleveland Ohio
Dean McGee Eye Institute Oklahoma City Oklahoma
Retina Consultants of Oklahoma Oklahoma City Oklahoma
Shields & Shields PC-Wills Eye Institute Philadelphia Pennsylvania
Retina Consultants of Carolina Greenville South Carolina
Tennessee Retina, PC Nashville Tennessee
Austin Retina Associates Austin Texas
Texas Retina Associates Dallas Texas
Eye Cancer Associates of Texas Houston Texas
Retina Center of Texas Southlake Texas
Retina Associates of Utah Salt Lake City Utah
Vitreoretinal Associates of Washington Bellevue Washington
University of Washington Medical Center Seattle Washington
University of Wisconsin Madison Madison Wisconsin
Eye Research Australia East Melbourne Victoria
Medical University Graz Graz Austria
Medizinische Universität Wien, Department of Ophthalmology and Optometry Vienna Austria
Cliniques universitaires Saint-Luc Brussels Belgium
Serac Eye and Skin Care Centre Calgary Alberta
Fakultni Thomayerova nemocnice Prague Krč
Fakultni nemocnice Plzen Pilsen Plzenský Kraj
Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha Prague Czechia
Centre Hospitalier Universitaire de Nice Nice Cedex 1
Hospices Civils de Lyon - Hôpital de La Croix Rousse - Hospital Lyon Rhone
Charité - Universitätsmedizin Berlin KöR Berlin Germany
Universitätsmedizin Essen Essen Germany
Uniklinikum Hamburg Eppendorf Hamburg Germany
Klinikum der LMU Muenchen München Germany
The Chaim Sheba Medical Center Tel-Hashomer Central District

+ 13 more sites — see the full list on the official registry below.

More Aura Biosciences trials in the USA

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer Active, not recruiting
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma Active, not recruiting
A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma Enrolling by invitation
Suprachoroidal Administration in Subjects With Metastases to the Choroid Recruiting

Other trials for the same condition

A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit Recruiting
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma Active, not recruiting
A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma Enrolling by invitation
A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors Active, not recruiting
Neoadjuvant Darovasertib in Primary Uveal Melanoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06007690 on ClinicalTrials.gov ↗ ← All trials in the USA