NCT02771340

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2016

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
3 years until next milestone

Results Posted

Study results publicly available

September 14, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

May 6, 2016

Results QC Date

August 18, 2020

Last Update Submit

September 11, 2020

Conditions

Uveal MelanomaChoroid Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Adverse Events

    30 days (plus or minus 5 days) after surgical procedure

Secondary Outcomes (2)

  • Changes in Plasma Levels 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

    Baseline to on or 1 day prior to surgical procedure day

Study Arms (3)

ICON-1 0.3 mg Singe Dose

EXPERIMENTAL

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

Biological: ICON-1

ICON-1 0.3 mg Repeat Dosing

EXPERIMENTAL

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

Biological: ICON-1

ICON-1 0.6 mg Repeat Dosing

EXPERIMENTAL

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

Biological: ICON-1

Interventions

ICON-1BIOLOGICAL

Intravitreal injection of ICON-1

Also known as: human Immuno-conjugate 1
ICON-1 0.3 mg Repeat DosingICON-1 0.3 mg Singe DoseICON-1 0.6 mg Repeat Dosing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

San Francisco, California, 94109, United States

Location

Unknown Facility

Denver, Colorado, 80401, United States

Location

Unknown Facility

Leawood, Kansas, 66211, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Grand Rapids, Michigan, 49546, United States

Location

Unknown Facility

Royal Oak, Michigan, 48073, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Uveal MelanomaChoroid Neoplasms

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal DiseasesChoroid Diseases

Results Point of Contact

Title
Gabriela Burian, M.D.
Organization
Iconic Therapeutics
gburian@iconictherapeutics.com
6504371000

Study Officials

  • Gabriela Burian, MD

    Iconic Therapeutics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 13, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 1, 2020

Results First Posted

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(8)