Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

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

Details

This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.

Keywords

Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma, Eye Cancer, Melanoma, Suprachoroidal Microinjector, PDT Laser

Eligibility

You can join if…

Open to people ages 18 years and up

You CAN'T join if...

  • Have known contraindications or sensitivities to the study drug or laser
  • Active ocular disease

Locations

  • UCLA Jules Stein Eye Institute
    Los Angeles California 90095 United States
  • Byers Eye Institute at Stanford University
    Palo Alto California 94303 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aura Biosciences
Links
Aura Biosciences
ID
NCT04417530
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 22 people participating
Last Updated