Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04417530 | Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma | PHASE2 | COMPLETED | 22 | — | — | Aug 5, 2020 | Apr 22, 2024 | Mar 3, 2025 | 22 | United States |
Adverse Events
| Arm | Type | Description |
|---|---|---|
| Cohort 1 AU-011& Laser | EXPERIMENTAL | Low dose of AU-011 + 1 laser application |
| Cohort 2 AU-011 & Laser | EXPERIMENTAL | Medium dose of AU-011 + 1 laser application |
| Cohort 3 AU-011 (belzupacap sarotalocan) & Laser | EXPERIMENTAL | Medium dose of AU-011 + 2 laser applications |
| Cohort 4 AU-011 & Laser | EXPERIMENTAL | Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments |
| Cohort 5 AU-011 & Laser | EXPERIMENTAL | 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. |
| Cohort 6 AU-011 & Laser | EXPERIMENTAL | High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment. |
| Name | Type | Description |
|---|---|---|
| AU-011 | DRUG | AU-011 Via Suprachoroidal Administration |
| Suprachoroidal Microinjector | DEVICE | Suprachoroidal Injection Device |
| PDT Laser | DEVICE | Laser Administration |
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 ...