Loading clinical trials...

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 Trials | Clareo Health

RECRUITINGPHASE3

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•Aura Biosciences

View on ClinicalTrials.gov

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).

Detailed 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.

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 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

Locations (71)

Retina Consultants of Alabama

Birmingham, Alabama, United States

UCSD Shiley Eye Institute, Jacobs Retina Center

La Jolla, California, United States

Doris Stein Eye Research Center

Los Angeles, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

Retinal Consultants Medical Group, Inc.

Sacramento, California, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

Retina Associates of Florida, PA

Tampa, Florida, United States

Emory Eye Center

Atlanta, Georgia, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Tufts Medical Center New England Eye Center

Boston, Massachusetts, United States

Key Dates

Start Date

December 6, 2023

Primary Completion Date

November 15, 2027

Completion Date

August 15, 2028

Last Updated

March 2, 2026

Enrollment

100

ESTIMATED participants

Conditions

Choroidal MelanomaIndeterminate LesionsUveal MelanomaOcular Melanoma

Interventions

Bel-sar

DRUG

Suprachoroidal Microinjector

DEVICE

Infrared Laser

DEVICE

Sham Infrared Laser

DEVICE

Sham Microinjector

DEVICE

Contacts

Medical Monitor

CONTACT

617-500-8864 clinical@aurabiosciences.com

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

RECRUITINGPHASE1

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

NCT05607095

Uveal MelanomaMelanoma+2 more

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 2, 2026Data 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

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

Inclusion Criteria

Exclusion Criteria

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

Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma