Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Study Overview
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Brief Summary
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The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

Detailed Description
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This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.

Official Title
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A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Conditions
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Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma

Intervention / Treatment
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* Drug: AU-011
* Device: Suprachoroidal Microinjector
* Device: PDT Laser


Participation Criteria
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Eligibility Criteria
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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 naïve for IL/CM Exclusion Criteria: Have known contraindications or sensitivities to the study drug or laser Active ocular disease

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: Cohort 1 AU-011 & Laser<br>Low dose of AU-011 + 1 laser application | Drug: AU-011<br>* AU-011 Via Suprachoroidal Administration with laser treatment<br>Device: Suprachoroidal Microinjector<br>* Suprachoroidal Injection Device<br>Device: PDT Laser<br>* Laser Administration<br>|
| Experimental: Cohort 2 AU-011 & Laser<br>Medium dose of AU-011 + 1 laser application | Drug: AU-011<br>* AU-011 Via Suprachoroidal Administration with laser treatment<br>Device: Suprachoroidal Microinjector<br>* Suprachoroidal Injection Device<br>Device: PDT Laser<br>* Laser Administration<br>|
| Experimental: Cohort 3 AU-011 & Laser<br>Medium dose of AU-011 + 2 laser applications | Drug: AU-011<br>* AU-011 Via Suprachoroidal Administration with laser treatment<br>Device: Suprachoroidal Microinjector<br>* Suprachoroidal Injection Device<br>Device: PDT Laser<br>* Laser Administration<br>|
| Experimental: Cohort 4 AU-011 & Laser<br>Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments | Drug: AU-011<br>* AU-011 Via Suprachoroidal Administration with laser treatment<br>Device: Suprachoroidal Microinjector<br>* Suprachoroidal Injection Device<br>Device: PDT Laser<br>* Laser Administration<br>|
| Experimental: Cohort 5 AU-011 & Laser<br>AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment. | Drug: AU-011<br>* AU-011 Via Suprachoroidal Administration with laser treatment<br>Device: Suprachoroidal Microinjector<br>* Suprachoroidal Injection Device<br>Device: PDT Laser<br>* Laser Administration<br>|
| Experimental: Cohort 6 AU-011 & Laser<br>High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment. | Drug: AU-011<br>* AU-011 Via Suprachoroidal Administration with laser treatment<br>Device: Suprachoroidal Microinjector<br>* Suprachoroidal Injection Device<br>Device: PDT Laser<br>* Laser Administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related AEs and treatment related serious adverse events (SAEs). | Adverse Events | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks. | Tumor Thickness Growth Rate | 52 weeks | 
| Time to reach tumor progression | Tumor progression | 52 weeks | 

 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