Phase 2 N=57 Treatment

Study in Subjects With Small Primary Choroidal Melanoma

Uveal Melanoma · Ocular Melanoma · Choroidal Melanoma

Bottom Line

View on ClinicalTrials.gov: NCT03052127 ↗

Enrolled (actual)

Serious AEs

7.1%

Results posted

Feb 2024

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 — 3; 3; 3; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Light-activated AU-011 (Drug); Laser Activation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aura Biosciences
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	3; 3; 3; 3; 3; 3	—
SECONDARY Immunogenicity (Anti-AU-011 Antibody Analysis)	2; 1; 3; 1; 0; 2	—
SECONDARY Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	1.872; 2.678; 2.389; 2.033; 2.233; 2.233	—
SECONDARY Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	7.740; 8.350; 7.700; 7.815; 8.853; 7.492	—
SECONDARY Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	89.7; 81.0; 87.3; 88.3; 75.7; 87.0	—

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.

Eligibility Criteria

Inclusion Criteria

Diagnosis of choroidal melanoma

Exclusion Criteria

Have known contraindications or sensitivities to the study drug

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03052127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.