Clinical trial NCT03052127: Study in Subjects With Small Primary Choroidal Melanoma
Official title: A Phase 1B/2 Open-Label, Ascending Single and Repeat Dose Clinical Trial Designed to Evaluate the Safety and Efficacy of Light-activated AU-011 for the Treatment of Subjects With Small Primary Choroidal Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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: 2017-02-14
Enrollment: 57
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 assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.

Detailed description: This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma.

Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of choroidal melanoma

Exclusion Criteria:

* Have known contraindications or sensitivities to the study drug

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
timeFrame: Informed consent through 1-2 years
Secondary outcomes:
measure: Immunogenicity (Anti-AU-011 Antibody Analysis)
timeFrame: Screening to various time points through 24 months
measure: Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
timeFrame: Change from baseline following treatment and at each subsequent visit through Week 52
measure: Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
timeFrame: Change from baseline following treatment and at each subsequent visit through Week 52
measure: Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
timeFrame: Change from baseline following treatment and at each subsequent visit through Week 52
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: Sacramento
country: United States
facility: Retina Consultants of Sacramento
state: California
city: Denver
country: United States
facility: Colorado Retina Associates
state: Colorado
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: 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: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
affiliation: Aura Biosciences
name: Abhijit Narvekar, MBBS
role: STUDY_DIRECTOR
References: