Clinical trial · Interventional
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
NCT06007690CI-TRIAL-00120057CoMpassactive not recruitingPhase 3ClinicalTrials.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 and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
Conditions
Conditions (4)
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 |
| Indeterminate Lesions | — | UNRESOLVED | — |
| Ocular Melanoma | Ocular Melanoma | ONTOLOGY_EXACT | 0.98 |
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bel-sar | Drug | — | UNRESOLVED |
| Infrared Laser | Device | — | UNRESOLVED |
| Sham Infrared Laser | Device | — | UNRESOLVED |
| Sham Microinjector | Device | — | UNRESOLVED |
| Suprachoroidal Microinjector | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- High dose bel-sar treatment arm & laser application
- description
- High dose of bel-sar + laser application
- interventionNames
- Drug: Bel-sar
- Device: Suprachoroidal Microinjector
- Device: Infrared Laser
- type
- EXPERIMENTAL
- label
- Low dose bel-sar treatment arm & laser application
- description
- Low dose of bel-sar + laser application
- interventionNames
- Drug: Bel-sar
- Device: Suprachoroidal Microinjector
- Device: Infrared Laser
- type
- SHAM_COMPARATOR
- label
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 naive for IL/CM (subjects who received PDT may be eligible) Exclusion Criteria: * Have known contraindications or sensitivities to the study drug or laser * Active ocular infection or disease
References
Publications (0)
Data not yet available
No reference posted for this study.