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.
Completed
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Light-activated AU-011 | 2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Single Low Dose Light-activated AU-011 | Experimental | Low dose Light-activated AU-011 followed by a single laser light application |
|
| Single Medium Dose Light-activated AU-011 | Experimental | Medium dose Light-activated AU-011 followed by a single laser light application |
|
| Single High Dose Light-activated AU-011 | Experimental | High dose Light-activated AU-011 followed by a single laser light application |
|
| 2 Repeat Medium Dose Light-activated AU-011 | Experimental | 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 | Experimental | 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 | Experimental | High dose Light-activated AU-011 followed by two laser light applications |
|
| 3 Repeat High Dose Light-activated AU-011 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 |
|
Inclusion Criteria:
- Diagnosis of choroidal melanoma
Exclusion Criteria:
- Have known contraindications or sensitivities to the study drug
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 |
| Time Frame: | Informed consent through 2 years |
| Safety Issue: | |
| Description: | Adverse events will be summarized by presenting the number and percentage of patients having any adverse event. |
| Measure: | Immunogenicity |
| Time Frame: | Screening to various time points through Week 52 |
| Safety Issue: | |
| Description: | Anti-Drug Antibody analysis |
| Measure: | Tumor size (thickness) measured by ultrasonography [Efficacy] |
| Time Frame: | Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years) |
| Safety Issue: | |
| Description: | Tumor size (thickness) measured by ultrasonography (millimeters) |
| Measure: | Tumor size (diameter) measured by fundus photography [Efficacy] |
| Time Frame: | Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years) |
| Safety Issue: | |
| Description: | Tumor size (diameter) measured by fundus photography (millimeters) |
| Measure: | Best Corrected Visual Acuity measured by ETDRS Method [Efficacy] |
| Time Frame: | Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years) |
| Safety Issue: | |
| Description: | Changes in ETDRS best corrected visual acuity (BCVA) |
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Aura Biosciences |
August 12, 2021
