Clinical trial NCT04417530: Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uveal Melanoma
Ocular Melanoma
Choroidal Melanoma
Keywords: Uveal Melanoma
Eye Cancer
Ocular Melanoma
Choroidal Melanoma
Lead sponsor: Aura Biosciences
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment related AEs and treatment related serious adverse events (SAEs).
timeFrame: 52 weeks
Secondary outcomes:
measure: Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
timeFrame: 52 weeks
measure: Time to reach tumor progression
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Associates SW, P.C.
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Jules Stein Eye Institute
state: California
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
city: Aurora
country: United States
facility: UCHealth Eye Center
state: Colorado
city: Tampa
country: United States
facility: Retina Associates of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Chicago
country: United States
facility: University of Illinois At Chicago Illinois Eye and Ear Infirmary
state: Illinois
city: Carmel
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Department of Ophthalmology and Visual Sciences
state: Iowa
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Ann Arbor
country: United States
facility: W. K. Kellogg Eye Center, University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, PC
state: Michigan
city: Minneapolis
country: United States
facility: Retina Center
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University Casey Eye Institute
state: Oregon
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Retina Consultants of Carolina, PA
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Health / Tennessee Retina, PC
state: Tennessee
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Dept of Ophthalmology & Visual Sciences
state: Wisconsin
Study officials:
affiliation: Aura Biosciences
name: Medical Monitor
role: STUDY_DIRECTOR
References: