Choroid Neoplasm, Uveal Melanoma
Conditions
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.
Interventions
BIOLOGICALICON-1
Intravitreal injection of ICON-1
Sponsors
Iconic Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Adverse Events | 30 days (plus or minus 5 days) after surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ICON-1 0.3 mg Singe Dose Patients will receive a single intravitreal dose of ICON-1 0.3 mg
ICON-1: Intravitreal injection of ICON-1 | 2 |
| ICON-1 0.3 mg Repeat Dosing Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
ICON-1: Intravitreal injection of ICON-1 | 3 |
| ICON-1 0.6 mg Repeat Dosing Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
ICON-1: Intravitreal injection of ICON-1 | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | ICON-1 0.3 mg Singe Dose | ICON-1 0.3 mg Repeat Dosing | ICON-1 0.6 mg Repeat Dosing | Total |
|---|---|---|---|---|
| Age, Continuous | 82.5 years STANDARD_DEVIATION 0.7 | 64.3 years STANDARD_DEVIATION 4 | 56.2 years STANDARD_DEVIATION 17.2 | 63.9 years STANDARD_DEVIATION 15.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 | 0 / 5 |
| other Total, other adverse events | 1 / 2 | 3 / 3 | 5 / 5 |
| serious Total, serious adverse events | 0 / 2 | 1 / 3 | 0 / 5 |
Outcome results
Primary
Occurrence of Adverse Events
Time frame: 30 days (plus or minus 5 days) after surgical procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ICON-1 0.3 mg Singe Dose | Occurrence of Adverse Events | Conjunctival hyperaemia | 0 Participants |
| ICON-1 0.3 mg Singe Dose | Occurrence of Adverse Events | Number of Participants with Adverse Events | 1 Participants |
| ICON-1 0.3 mg Singe Dose | Occurrence of Adverse Events | Iridocyclitis | 1 Participants |
| ICON-1 0.3 mg Singe Dose | Occurrence of Adverse Events | Conjunctival Haemorrhage | 0 Participants |
| ICON-1 0.3 mg Singe Dose | Occurrence of Adverse Events | Intraocular Pressure Increased | 1 Participants |
| ICON-1 0.3 mg Singe Dose | Occurrence of Adverse Events | Phototoxic Injury/Surgical Complication | 0 Participants |
| ICON-1 0.3 mg Singe Dose | Occurrence of Adverse Events | Punctate Keratitis | 0 Participants |
| ICON-1 0.3 mg Repeat Dosing | Occurrence of Adverse Events | Iridocyclitis | 0 Participants |
| ICON-1 0.3 mg Repeat Dosing | Occurrence of Adverse Events | Conjunctival Haemorrhage | 2 Participants |
| ICON-1 0.3 mg Repeat Dosing | Occurrence of Adverse Events | Conjunctival hyperaemia | 1 Participants |
| ICON-1 0.3 mg Repeat Dosing | Occurrence of Adverse Events | Punctate Keratitis | 1 Participants |
| ICON-1 0.3 mg Repeat Dosing | Occurrence of Adverse Events | Number of Participants with Adverse Events | 3 Participants |
| ICON-1 0.3 mg Repeat Dosing | Occurrence of Adverse Events | Phototoxic Injury/Surgical Complication | 1 Participants |
| ICON-1 0.3 mg Repeat Dosing | Occurrence of Adverse Events | Intraocular Pressure Increased | 0 Participants |
| ICON-1 0.6 mg Repeat Dosing | Occurrence of Adverse Events | Conjunctival hyperaemia | 0 Participants |
| ICON-1 0.6 mg Repeat Dosing | Occurrence of Adverse Events | Intraocular Pressure Increased | 2 Participants |
| ICON-1 0.6 mg Repeat Dosing | Occurrence of Adverse Events | Phototoxic Injury/Surgical Complication | 0 Participants |
| ICON-1 0.6 mg Repeat Dosing | Occurrence of Adverse Events | Iridocyclitis | 0 Participants |
| ICON-1 0.6 mg Repeat Dosing | Occurrence of Adverse Events | Punctate Keratitis | 0 Participants |
| ICON-1 0.6 mg Repeat Dosing | Occurrence of Adverse Events | Conjunctival Haemorrhage | 3 Participants |
| ICON-1 0.6 mg Repeat Dosing | Occurrence of Adverse Events | Number of Participants with Adverse Events | 5 Participants |
Secondary
Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study
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
Population: End-of-Study assessments obtained for brachytherapy (placing radioactive material in the eye) patients only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ICON-1 0.3 mg Singe Dose | Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study | -3 Letters | Standard Deviation 4.2 |
| ICON-1 0.3 mg Repeat Dosing | Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study | -4.3 Letters | Standard Deviation 11.8 |
| ICON-1 0.6 mg Repeat Dosing | Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study | -3.6 Letters | Standard Deviation 6.9 |
Secondary
Changes in Plasma Levels of ICON-1.
Time frame: Baseline to 1 day after last dose of ICON-1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICON-1 0.3 mg Singe Dose | Changes in Plasma Levels of ICON-1. | 0 ng/ml-All LLOQ |
| ICON-1 0.3 mg Repeat Dosing | Changes in Plasma Levels of ICON-1. | 0 ng/ml-All LLOQ |
| ICON-1 0.6 mg Repeat Dosing | Changes in Plasma Levels of ICON-1. | 0 ng/ml-All LLOQ |