Clinical trial NCT06007690: 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Choroidal Melanoma
Indeterminate Lesions
Uveal Melanoma
Ocular Melanoma
Keywords: Uveal Melanoma
Eye Cancer
Ocular Melanoma
Choroidal Melanoma
Lead sponsor: Aura Biosciences
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

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 naive for IL/CM (subjects who received PDT may be eligible)

Exclusion Criteria:

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

Primary outcomes:
measure: Time to reach tumor progression
timeFrame: 65 weeks
Secondary outcomes:
measure: Time to composite endpoint
timeFrame: 65 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Retina Consultants of Alabama
state: Alabama
city: La Jolla
country: United States
facility: UCSD Shiley Eye Institute, Jacobs Retina Center
state: California
city: Los Angeles
country: United States
facility: Doris Stein Eye Research Center
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: Lakewood
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida, PA
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center New England Eye Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts Eye and Ear
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 (ARC) P.C.
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: Nebraska Medicine's Truhlsen Eye Institute
state: Nebraska
city: Wayne
country: United States
facility: New Jersey Retina Group
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Cleveland
country: United States
facility: Cole Eye Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Shields & Shields PC-Wills Eye Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Retina Consultants of Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Dallas
country: United States
facility: UT, Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: Retina Associates of South Texas, P.A.
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Bellevue
country: United States
facility: Vitreoretinal Associates of Washington
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Brisbane
country: Australia
facility: Terrace Eye Centre
state: Queensland
city: East Melbourne
country: Australia
facility: Eye Research Australia
state: Victoria
city: Leuven
country: Belgium
facility: UZ Leuven
city: Calgary
country: Canada
facility: Serac Eye and Skin Care Centre
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Eye Tumour Clinic
state: Ontario
city: Québec City
country: Canada
facility: Centre Hospitalier de l'Universite Laval
state: Quebec
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice
state: Krč
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen
state: Plzenský Kraj
city: Praha 6
country: Czechia
facility: Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
state: Cedex 1
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin KöR
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Hadassah Medical Center, Ein-Karem
state: Yerushalayim
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital Nhs Foundation Trust Broadgreen Hospital
state: England
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Nhs Foundation Trust - Royal Hallamshire Hospital
Study officials:
affiliation: Aura Biosciences
name: Medical Monitor
role: STUDY_DIRECTOR
References: