AU-011-301 (Primary Indeterminate Lesions or Small Choroidal Melanoma)

Purpose of this Study

We are doing this study to find out if a study drug called belzupacap sarotalocan (bel-sar) is a safe and effective option when it is combined with laser light therapy for people who have a type of eye cancer called an indeterminate lesion (a growth in your eye that is suspected to be melanoma) or choroidal melanoma, which is also known as eye melanoma.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Have no evidence of metastatic disease
  • Have not received any previous treatment for eye melanoma
For more information, contact the study team at ethel.garcia@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment to 1 of 3 groups:
  • Group 1: If you are in this group, you will receive a high dose of the study drug and will then get the laser application.
  • Group 2: If you are in this group, you will receive a lower dose of the study drug and will then get the laser application.
  • Group 3: If you are in this group, you will receive a sham dose (inactive dosing that doesn't have drug) and will then get a sham laser application.
The sham procedure will be the same as for the study drug and laser light application, except that no study drug will be injected in the eye (only firm pressure to the eyeball will be applied with a needleless syringe) and no laser light will be applied during the sham laser procedure. Your chance of being assigned to any of the 3 groups are as follows:
  • Group 1: 40%
  • Group 2: 20%
  • Group 3: 40%

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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

Principal Investigator

Miguel
Materin

Protocol Number

PRO00115154

NCT ID

NCT06007690

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov