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

COMPLETEDPHASE2

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

NCT04417530•Aura Biosciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

August 5, 2020

Primary Completion Date

April 22, 2024

Completion Date

April 22, 2024

Last Updated

March 3, 2025

Enrollment

ACTUAL participants

Conditions

Uveal MelanomaOcular MelanomaChoroidal Melanoma

Interventions

AU-011

DRUG

Suprachoroidal Microinjector

DEVICE

PDT Laser

DEVICE

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

Choroidal MelanomaIndeterminate Lesions+2 more

View study

RECRUITINGPHASE2/PHASE3

A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

NCT06581406

Metastatic Uveal Melanoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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

A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

Adding IL-2 to Tebentafusp to Eradicate Cancer Progression

Adjuvant Melatonin for Uveal Melanoma