Clinical trial · Interventional
Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
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
NCT04417530CI-TRIAL-00086684completedPhase 2ClinicalTrials.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 determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AU-011 | Drug | — | UNRESOLVED |
| PDT Laser | Device | — | UNRESOLVED |
| Suprachoroidal Microinjector | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1 AU-011& Laser
- description
- Low dose of AU-011 + 1 laser application
- interventionNames
- Drug: AU-011
- Device: Suprachoroidal Microinjector
- Device: PDT Laser
- type
- EXPERIMENTAL
- label
- Cohort 2 AU-011 & Laser
- description
- Medium dose of AU-011 + 1 laser application
- interventionNames
- Drug: AU-011
- Device: Suprachoroidal Microinjector
- Device: PDT Laser
- type
- EXPERIMENTAL
- label
- Cohort 3 AU-011 (belzupacap sarotalocan) & Laser
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.