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

I

Iconic Therapeutics

Status and phase

Completed
Phase 1

Conditions

Choroid Neoplasm
Uveal Melanoma

Treatments

Biological: ICON-1

Study type

Interventional

Funder types

Industry

Identifiers

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)

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

Trial documents
1

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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