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

Phase 1

• Conditions: Primary Indeterminate Lesions or Small Choroidal Melanoma; MedDRA version: 20.0Level: HLTClassification code: 10030052Term: Ocular melanomas Class: 10029104; MedDRA version: 21.0Level: PTClassification code: 10025839Term: Malignant neoplasm of choroid Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10008773Term: Choroid melanoma Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10081431Term: Uveal melanoma Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504655-27-00
• Lead Sponsor: Aura Biosciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) with documented early growth, Have no evidence of metastatic disease confirmed by imaging, Be treatment naïve for their IL/CM (Note: eligibility for subjects who have received treatment with photodynamic therapy >12 months prior to enrollment should be discussed with the medical monitor for approval prior to enrollment).

Exclusion Criteria

Any active eye infection or ocular disease in the study eye (other than IL/CM), Have known contraindications or sensitivities to the study drug or laser, Have a history of any ocular surgery/procedure that could alter the SCS and affect the SC administration of study drug (e.g., scleral buckle, laser retinopexy, macular laser, or panretinal photocoagulation).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified