Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Trial ID or NCT#
NCT04417530
Status
NOT RECRUITING
Purpose
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).
Official Title
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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
Investigator(s)
Prithvi Mruthyunjaya, MD, MHS
Ophthalmologic oncologist,
Retina specialist,
Ophthalmologist
Alan Adler Professor of Ophthalmology and Professor, by courtesy, of Radiation Oncology
Contact us to find out if this trial is right for you.
Contact
Mariana Nunez
650-723-6995
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