Study in Subjects With Small Primary Choroidal Melanoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma

Intervention / Treatment
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* Drug: Light-activated AU-011
* Device: Laser Activation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of choroidal melanoma Exclusion Criteria: Have known contraindications or sensitivities to the study drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Low Dose Light-activated AU-011<br>Low dose Light-activated AU-011 followed by a single laser light application | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: Single Medium Dose Light-activated AU-011<br>Medium dose Light-activated AU-011 followed by a single laser light application | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: Single High Dose Light-activated AU-011<br>High dose Light-activated AU-011 followed by a single laser light application | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: 2 Repeat Medium Dose Light-activated AU-011<br>2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: 3 Repeat Medium Dose Light-activated AU-011<br>3 repeat medium doses of Light-activated AU-011 followed by a single laser light application | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: Single High Dose Light-activated AU-011 x 2 lasers<br>High dose Light-activated AU-011 followed by two laser light applications | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: 3 Repeat High Dose Light-activated AU-011<br>3 repeat high doses of Light-activated AU-011 each followed by a single laser light application | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: 3 Repeat High Dose Light-activated AU-011 x 2 lasers<br>3 repeat high doses of Light-activated AU-011 each followed by two laser light applications | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers<br>Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects) | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: Observation until Documented Growth of Tumor<br>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 | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: 2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers<br>2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|
| Experimental: Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers<br>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 | Drug: Light-activated AU-011<br>* Study treatment<br>Device: Laser Activation<br>* Study treatment<br>* Other names: PDT Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 | Adverse events will be summarized by presenting the number and percentage of patients having any adverse event. | Informed consent through 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | Anti-Drug Antibody analysis | Screening to various time points through Week 52 | 
| Tumor size (thickness) measured by ultrasonography [Efficacy] | Tumor size (thickness) measured by ultrasonography (millimeters) | Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years) | 
| Tumor size (diameter) measured by fundus photography [Efficacy] | Tumor size (diameter) measured by fundus photography (millimeters) | Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years) | 
| Best Corrected Visual Acuity measured by ETDRS Method [Efficacy] | Changes in ETDRS best corrected visual acuity (BCVA) | Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uveal melanoma, Eye cancer, Ocular melanoma, Choroidal melanoma