Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma

Iconic Therapeutics

Status and phase: Completed; Phase 1

Conditions: Choroid Neoplasm; Uveal Melanoma

Treatments: Biological: ICON-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02771340

IT-003

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

ICON-1 0.3 mg Singe Dose

Experimental group

Description:

Patients will receive a single intravitreal dose of ICON-1 0.3 mg

Treatment:

Biological: ICON-1

ICON-1 0.3 mg Repeat Dosing

Experimental group

Description:

Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart

Treatment:

Biological: ICON-1

ICON-1 0.6 mg Repeat Dosing

Experimental group

Description:

Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart

Treatment:

Biological: ICON-1