Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Phase 2

Completed

• Conditions: Uveal Melanoma; Ocular Melanoma; Choroidal Melanoma
• Interventions: Drug: AU-011; Device: Suprachoroidal Microinjector; Device: PDT Laser

• Registration Number: NCT04417530
• Lead Sponsor: Aura Biosciences

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).

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 Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Study Start: 2020-08-05
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Disposition First Posted: 2024-08-21
• Status Verified: 2025-02
• Disposition First Submitted: 2025-02-21
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 naïve for IL/CM

Exclusion Criteria

• Have known contraindications or sensitivities to the study drug or laser
• Active ocular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1 AU-011& Laser	Suprachoroidal Microinjector	Low dose of AU-011 + 1 laser application
Cohort 1 AU-011& Laser	PDT Laser	Low dose of AU-011 + 1 laser application
Cohort 2 AU-011 & Laser	Suprachoroidal Microinjector	Medium dose of AU-011 + 1 laser application
Cohort 2 AU-011 & Laser	PDT Laser	Medium dose of AU-011 + 1 laser application
Cohort 3 AU-011 (belzupacap sarotalocan) & Laser	Suprachoroidal Microinjector	Medium dose of AU-011 + 2 laser applications
Cohort 3 AU-011 (belzupacap sarotalocan) & Laser	PDT Laser	Medium dose of AU-011 + 2 laser applications
Cohort 4 AU-011 & Laser	Suprachoroidal Microinjector	Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Cohort 4 AU-011 & Laser	PDT Laser	Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Cohort 5 AU-011 & Laser	Suprachoroidal Microinjector	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.
Cohort 5 AU-011 & Laser	PDT Laser	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.
Cohort 6 AU-011 & Laser	Suprachoroidal Microinjector	High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
Cohort 6 AU-011 & Laser	PDT Laser	High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
Cohort 1 AU-011& Laser	AU-011	Low dose of AU-011 + 1 laser application
Cohort 2 AU-011 & Laser	AU-011	Medium dose of AU-011 + 1 laser application
Cohort 3 AU-011 (belzupacap sarotalocan) & Laser	AU-011	Medium dose of AU-011 + 2 laser applications
Cohort 4 AU-011 & Laser	AU-011	Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Cohort 5 AU-011 & Laser	AU-011	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.
Cohort 6 AU-011 & Laser	AU-011	High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.

Primary Outcome Measures

Name	Time	Method
Treatment related AEs and treatment related serious adverse events (SAEs).	52 weeks	Adverse Events

Secondary Outcome Measures

Name	Time	Method
Time to reach tumor progression	52 weeks	Tumor progression
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.	52 weeks	Tumor Thickness Growth Rate

Trial Locations

Locations (22)

Retina Associates SW, P.C.; 🇺🇸 Tucson, Arizona, United States

UCLA Jules Stein Eye Institute; 🇺🇸 Los Angeles, California, United States

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States

UCHealth Eye Center; 🇺🇸 Aurora, Colorado, United States

Retina Associates of Florida; 🇺🇸 Tampa, Florida, United States

Emory Eye Center; 🇺🇸 Atlanta, Georgia, United States

University of Illinois At Chicago Illinois Eye and Ear Infirmary; 🇺🇸 Chicago, Illinois, United States

Midwest Eye Institute; 🇺🇸 Carmel, Indiana, United States

University of Iowa Department of Ophthalmology and Visual Sciences; 🇺🇸 Iowa City, Iowa, United States

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

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