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

• Sponsor: Iconic Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02771340
• Collaborator: (none)
• Enrollment: 10
• Locations: 8
• Arms: 3
• Duration (Months): 16
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveal Melanoma; Choroid Neoplasm	Biological: ICON-1	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Occurrence of Adverse Events [30 days (plus or minus 5 days) after surgical procedure]

Secondary Outcome Measures

1. Changes in Plasma Levels of ICON-1. [Baseline to 1 day after last dose of ICON-1]

2. Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Francisco	California	United States	94109
2		Denver	Colorado	United States	80401
3		Leawood	Kansas	United States	66211
4		Boston	Massachusetts	United States	02114
5		Grand Rapids	Michigan	United States	49546
6		Royal Oak	Michigan	United States	48073
7		Portland	Oregon	United States	97239
8		Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Iconic Therapeutics, Inc.

Investigators

• Study Director: Gabriela Burian, MD, Iconic Therapeutics, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 5, 2016

More Information

Additional Information:

• CURE OM (Community United for Research and Education of Ocular Melanoma)
• Ocular Melanoma Foundation (OMF)

Publications

None provided.

• Responsible Party: Iconic Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02771340
• Other Study ID Numbers: IT-003
• First Posted: May 13, 2016
• Last Update Posted: Oct 1, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Melanoma; Uveal Neoplasms; Choroid Neoplasms; Immunoconjugates

Study Results

Participant Flow

Arm/Group Title	ICON-1 0.3 mg Singe Dose	ICON-1 0.3 mg Repeat Dosing	ICON-1 0.6 mg Repeat Dosing
Arm/Group Description	Patients will receive a single intravitreal dose of ICON-1 0.3 mg ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart ICON-1: Intravitreal injection of ICON-1
Period Title: Overall Study
STARTED	2	3	5
COMPLETED	2	3	5
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	ICON-1 0.3 mg Singe Dose	ICON-1 0.3 mg Repeat Dosing	ICON-1 0.6 mg Repeat Dosing	Total
Arm/Group Description	Patients will receive a single intravitreal dose of ICON-1 0.3 mg ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart ICON-1: Intravitreal injection of ICON-1	Total of all reporting groups
Overall Participants	2	3	5	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	82.5 (0.7)	64.3 (4.0)	56.2 (17.2)	63.9 (15.7)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	1 20%	1 10%
Male	2 100%	3 100%	4 80%	9 90%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	2 100%	3 100%	5 100%	10 100%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%	3 100%	5 100%	10 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICON-1 0.3 mg Singe Dose	ICON-1 0.3 mg Repeat Dosing	ICON-1 0.6 mg Repeat Dosing
Arm/Group Description	Patients will receive a single intravitreal dose of ICON-1 0.3 mg ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart ICON-1: Intravitreal injection of ICON-1
Measure Participants	2	3	5
Number of Participants with Adverse Events	1 50%	3 100%	5 100%
Phototoxic Injury/Surgical Complication	0 0%	1 33.3%	0 0%
Conjunctival Haemorrhage	0 0%	2 66.7%	3 60%
Conjunctival hyperaemia	0 0%	1 33.3%	0 0%
Punctate Keratitis	0 0%	1 33.3%	0 0%
Iridocyclitis	1 50%	0 0%	0 0%
Intraocular Pressure Increased	1 50%	0 0%	2 40%

2. Secondary Outcome

Title	Changes in Plasma Levels of ICON-1.
Time Frame	Baseline to 1 day after last dose of ICON-1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICON-1 0.3 mg Singe Dose	ICON-1 0.3 mg Repeat Dosing	ICON-1 0.6 mg Repeat Dosing
Arm/Group Description	Patients will receive a single intravitreal dose of ICON-1 0.3 mg ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart ICON-1: Intravitreal injection of ICON-1
Measure Participants	2	3	5
Number [ng/ml-All LLOQ]	0	0	0

3. Secondary Outcome

Title	Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study
Description	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.
Time Frame	Baseline to on or 1 day prior to surgical procedure day

Outcome Measure Data

Analysis Population Description

End-of-Study assessments obtained for brachytherapy (placing radioactive material in the eye) patients only.

Arm/Group Title	ICON-1 0.3 mg Singe Dose	ICON-1 0.3 mg Repeat Dosing	ICON-1 0.6 mg Repeat Dosing
Arm/Group Description	Patients will receive a single intravitreal dose of ICON-1 0.3 mg ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart ICON-1: Intravitreal injection of ICON-1	Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart ICON-1: Intravitreal injection of ICON-1
Measure Participants	1	1	2
Mean (Standard Deviation) [Letters]	-3 (4.2)	-4.3 (11.8)	-3.6 (6.9)

Adverse Events

Time Frame	During the course of the study and for 30 days last post injection.
Arm/Group Title	ICON-1 0.3 mg Singe Dose		ICON-1 0.3 mg Repeat Dosing		ICON-1 0.6 mg Repeat Dosing
Arm/Group Description	Patients will receive a single intravitreal dose of ICON-1 0.3 mg ICON-1: Intravitreal injection of ICON-1		Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart ICON-1: Intravitreal injection of ICON-1		Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart ICON-1: Intravitreal injection of ICON-1
All Cause Mortality
	ICON-1 0.3 mg Singe Dose		ICON-1 0.3 mg Repeat Dosing		ICON-1 0.6 mg Repeat Dosing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)		0/5 (0%)
Serious Adverse Events
	ICON-1 0.3 mg Singe Dose		ICON-1 0.3 mg Repeat Dosing		ICON-1 0.6 mg Repeat Dosing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		1/3 (33.3%)		0/5 (0%)
Eye disorders
Phototoxic Injury/Surgical Complication	0/2 (0%)	0	1/3 (33.3%)	1	0/5 (0%)	0
Other (Not Including Serious) Adverse Events
	ICON-1 0.3 mg Singe Dose		ICON-1 0.3 mg Repeat Dosing		ICON-1 0.6 mg Repeat Dosing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		3/3 (100%)		5/5 (100%)
Eye disorders
Conjunctival Haemorrhage	0/2 (0%)	0	2/3 (66.7%)	2	3/5 (60%)	3
Conjunctival hyperaemia	0/2 (0%)	0	1/3 (33.3%)	1	0/5 (0%)	0
Punctate Keratitis	0/2 (0%)	0	1/3 (33.3%)	1	0/5 (0%)	0
Iridocyclitis	1/2 (50%)	1	0/3 (0%)	0	0/5 (0%)	0
Intraocular Pressure Increased	1/2 (50%)	1	0/3 (0%)	0	2/5 (40%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.