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

September 11, 2020 updated by: Iconic Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
    • Colorado
      • Denver, Colorado, United States, 80401
    • Kansas
      • Leawood, Kansas, United States, 66211
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
      • Royal Oak, Michigan, United States, 48073
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ICON-1 0.3 mg Singe Dose
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
Biological: ICON-1
Intravitreal injection of ICON-1
Other Names:
  • human Immuno-conjugate 1
EXPERIMENTAL: ICON-1 0.3 mg Repeat Dosing
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
Biological: ICON-1
Intravitreal injection of ICON-1
Other Names:
  • human Immuno-conjugate 1
EXPERIMENTAL: ICON-1 0.6 mg Repeat Dosing
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
Biological: ICON-1
Intravitreal injection of ICON-1
Other Names:
  • human Immuno-conjugate 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Adverse Events
Time Frame: 30 days (plus or minus 5 days) after surgical procedure
30 days (plus or minus 5 days) after surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Plasma Levels of ICON-1.
Time Frame: Baseline to 1 day after last dose of ICON-1
Baseline to 1 day after last dose of ICON-1
Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study
Time Frame: Baseline to on or 1 day prior to surgical procedure day
Best-corrected visual acuity (BCVA) will be measured for each eye, pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS)-like retro-illuminated charts. BCVA will be recorded as the total letter score in each eye.
Baseline to on or 1 day prior to surgical procedure day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iconic Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (ESTIMATE)

May 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IT-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uveal Melanoma

Clinical Trials on ICON-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe