Clinical trial · Interventional
Study in Subjects With Small Primary Choroidal Melanoma
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
NCT03052127CI-TRIAL-00073524completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choroidal Melanoma | Choroid Melanoma | ALIAS | 0.90 |
| Ocular Melanoma | Ocular Melanoma | ONTOLOGY_EXACT | 0.98 |
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser Activation | Device | — | UNRESOLVED |
| Light-activated AU-011 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- Single Low Dose Light-activated AU-011
- description
- Low dose Light-activated AU-011 followed by a single laser light application
- interventionNames
- Drug: Light-activated AU-011
- Device: Laser Activation
- type
- EXPERIMENTAL
- label
- Single Medium Dose Light-activated AU-011
- description
- Medium dose Light-activated AU-011 followed by a single laser light application
- interventionNames
- Drug: Light-activated AU-011
- Device: Laser Activation
- type
- EXPERIMENTAL
- label
- Single High Dose Light-activated AU-011
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of choroidal melanoma Exclusion Criteria: * Have known contraindications or sensitivities to the study drug
References
Publications (0)
Data not yet available
No reference posted for this study.