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 (Aura)
Sponsor: Aura Biosciences, Inc.
Principal Investigator: Michael Altaweel, MD
Study Coordinator: Bonnie Verges
This study will assess the safety and tolerability of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma (IL/CM).
Patients will be randomly assigned to one out of six study treatment groups using dose escalation and dose expansion trial designs. The dose escalation phase will evaluate the safety and efficacy of up to 3 dose levels and repeat dose regimens of AU-011. The dose expansion phase will establish the safety and efficacy of the highest dose regimen of AU-011.
Diagnosis and Key Eligibility Criteria:
At least 18 years of age with evidence of metastatic disease confirmed by abdominal and chest imaging within 3 months prior to screening and a clinical diagnosis of primary indeterminate lesions and small choroidal melanoma (IL/CM). Patients may not have had prior treatment for their IL/CM. Other prior investigational drug or medical device is allowed but a washout period of 30 days or 5 half-lives before visit 1 is required.
Duration of study: Approximately 3.5 years.
For more information, contact Bonnie Verges (608) 265-5292.