Study in Subjects With Small Primary Choroidal Melanoma

Phase 1

Completed

• Conditions: Ocular Melanoma; Uveal Melanoma; Choroidal Melanoma
• Interventions: Drug: Light-activated AU-011; Device: Laser Activation

• Registration Number: NCT03052127
• Lead Sponsor: Aura Biosciences

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.

Study Timeline

• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Study Start: 2017-02-27
• Primary Completion: 2021-01-26
• Study Completion: 2021-01-26
• Disposition First Submitted: 2022-01-05
• Results First Submitted: 2023-12-19
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Results First Posted: 2024-02-01
• Disposition First Posted: 2024-02-01
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Diagnosis of choroidal melanoma

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Exclusion Criteria

• Have known contraindications or sensitivities to the study drug

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
2 Repeat Medium Dose Light-activated AU-011	Light-activated AU-011	2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
Single High Dose Light-activated AU-011	Laser Activation	High dose Light-activated AU-011 followed by a single laser light application
Single Low Dose Light-activated AU-011	Laser Activation	Low dose Light-activated AU-011 followed by a single laser light application
Single Medium Dose Light-activated AU-011	Laser Activation	Medium dose Light-activated AU-011 followed by a single laser light application
2 Repeat Medium Dose Light-activated AU-011	Laser Activation	2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
3 Repeat Medium Dose Light-activated AU-011	Laser Activation	3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Single High Dose Light-activated AU-011 x 2 lasers	Laser Activation	High dose Light-activated AU-011 followed by two laser light applications
3 Repeat High Dose Light-activated AU-011	Laser Activation	3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
3 Repeat High Dose Light-activated AU-011 x 2 lasers	Laser Activation	3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers	Laser Activation	Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
Observation until Documented Growth of Tumor	Laser Activation	Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers	Laser Activation	2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers	Laser Activation	2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
3 Repeat Medium Dose Light-activated AU-011	Light-activated AU-011	3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Single Low Dose Light-activated AU-011	Light-activated AU-011	Low dose Light-activated AU-011 followed by a single laser light application
Single High Dose Light-activated AU-011 x 2 lasers	Light-activated AU-011	High dose Light-activated AU-011 followed by two laser light applications
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers	Light-activated AU-011	Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers	Light-activated AU-011	2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Observation until Documented Growth of Tumor	Light-activated AU-011	Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers	Light-activated AU-011	2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Single Medium Dose Light-activated AU-011	Light-activated AU-011	Medium dose Light-activated AU-011 followed by a single laser light application
Single High Dose Light-activated AU-011	Light-activated AU-011	High dose Light-activated AU-011 followed by a single laser light application
3 Repeat High Dose Light-activated AU-011	Light-activated AU-011	3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
3 Repeat High Dose Light-activated AU-011 x 2 lasers	Light-activated AU-011	3 repeat high doses of Light-activated AU-011 each followed by two laser light applications

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011	Informed consent through 1-2 years	Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.

Secondary Outcome Measures

Name	Time	Method
Immunogenicity (Anti-AU-011 Antibody Analysis)	Screening to various time points through 24 months	Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]	Change from baseline following treatment and at each subsequent visit through Week 52	Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]	Change from baseline following treatment and at each subsequent visit through Week 52	Change from Baseline in tumor Largest Basal Diameter (LBD) assessed at each study visit based on fundus photos (millimeters) in participants treated with AU-011.
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye	Change from baseline following treatment and at each subsequent visit through Week 52	Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.

Trial Locations

Locations (13)

UCLA Jules Stein Eye Institute; 🇺🇸 Los Angeles, California, United States

Associated Retinal Consultants, PC; 🇺🇸 Royal Oak, Michigan, United States

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States

Retina Center; 🇺🇸 Minneapolis, Minnesota, United States

W. K. Kellogg Eye Center, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

Retina Associates SW, P.C.; 🇺🇸 Tucson, Arizona, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Colorado Retina Associates; 🇺🇸 Denver, Colorado, United States

Retina Consultants of Sacramento; 🇺🇸 Sacramento, California, United States

Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Retina Consultants of Carolina, PA; 🇺🇸 Greenville, South Carolina, United States