Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Aura Biosciences logo

Aura Biosciences

Status and phase

Active, not recruiting
Phase 2

Conditions

Ocular Melanoma
Choroidal Melanoma
Uveal Melanoma

Treatments

Device: Suprachoroidal Microinjector
Device: PDT Laser
Drug: AU-011

Study type

Interventional

Funder types

Industry

Identifiers

NCT04417530
AU-011-202

Details and patient eligibility

About

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).

Full description

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

22 participants in 6 patient groups

Cohort 1 AU-011 & Laser
Experimental group
Description:
Low dose of AU-011 + 1 laser application
Treatment:
Drug: AU-011
Device: PDT Laser
Device: Suprachoroidal Microinjector
Cohort 2 AU-011 & Laser
Experimental group
Description:
Medium dose of AU-011 + 1 laser application
Treatment:
Drug: AU-011
Device: PDT Laser
Device: Suprachoroidal Microinjector
Cohort 3 AU-011 & Laser
Experimental group
Description:
Medium dose of AU-011 + 2 laser applications
Treatment:
Drug: AU-011
Device: PDT Laser
Device: Suprachoroidal Microinjector
Cohort 4 AU-011 & Laser
Experimental group
Description:
Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Treatment:
Drug: AU-011
Device: PDT Laser
Device: Suprachoroidal Microinjector
Cohort 5 AU-011 & Laser
Experimental group
Description:
AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
Treatment:
Drug: AU-011
Device: PDT Laser
Device: Suprachoroidal Microinjector
Cohort 6 AU-011 & Laser
Experimental group
Description:
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
Treatment:
Drug: AU-011
Device: PDT Laser
Device: Suprachoroidal Microinjector

Trial contacts and locations

22

Loading...

Central trial contact

Medical Monitor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems