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Phase 2 Trial to Evaluate Safety and Efficacy of AU-011 Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Trial Status: Active

The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.

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

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: Alisa Molina
Phone: 310-794-5596

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: APPROVED

A Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation Phase

(Open-label, Ascending Single and Repeat Dose) and a Randomized, Masked Dose Expansion Phase

Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate

Lesions and Small Choroidal Melanoma.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Aura Biosciences

  • Primary ID AU-011-202
  • Secondary IDs NCI-2020-04854
  • Clinicaltrials.gov ID NCT04417530