Not currently recruiting at UCSF

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

a study on Skin Cancer/Melanoma Indeterminate Lesions Ocular Melanoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

Details

This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.

Keywords

Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma, Eye Cancer, Melanoma, Bel-sar, Suprachoroidal Microinjector, Infrared Laser

Eligibility

You can join if…

Open to people ages 18 years and up

  • Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
  • Have no evidence of metastatic disease confirmed by imaging
  • Be treatment naive for IL/CM (subjects who received PDT may be eligible)

You CAN'T join if...

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

Locations

  • UCSF Ocular Oncology Clinic not yet accepting patients
    San Francisco California 94143 United States
  • Stanford University School of Medicine accepting new patients
    Palo Alto California 94303 United States
  • Retinal Consultants Medical Group, Inc. accepting new patients
    Sacramento California 95825 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Aura Biosciences
Links
Aura Biosciences
ID
NCT06007690
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated