Clinical trial · Interventional
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
A Phase 1, Open-label, Multicenter Study Evaluating the Safety and Tolerability, Biologic Activity, Pharmacodynamics, and Pharmacokinetics of Single and Repeated Escalating Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Who Are Planned to Undergo Enucleation or Brachytherapy
- 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 purpose of this study is to evaluate the safety, tolerability, biological activity, pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo enucleation or brachytherapy of the affected eye.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choroid Neoplasm | Choroid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICON-1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ICON-1 0.3 mg Singe Dose
- description
- Patients will receive a single intravitreal dose of ICON-1 0.3 mg
- interventionNames
- Biological: ICON-1
- type
- EXPERIMENTAL
- label
- ICON-1 0.3 mg Repeat Dosing
- description
- Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
- interventionNames
- Biological: ICON-1
- type
- EXPERIMENTAL
- label
- ICON-1 0.6 mg Repeat Dosing
- description
- Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females of any race at least 18 years of age * Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye * Planned enucleation or brachytherapy of the study eye due to uveal melanoma Exclusion Criteria: * Uveal melanoma in the study eye originating in the anterior uveal tract (iris) * Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia) * Woman who is pregnant or lactating
References
Publications (0)
Data not yet available