Uveal MelanomaPhase 1NCT02771340
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
A Phase 1 study testing ICON-1 in people with Uveal Melanoma and Choroid Neoplasm, run by Iconic Therapeutics, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma, Choroid Neoplasm
- What is being tested?
- ICON-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2016to Sep 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Boston, Massachusetts, 02114
Study site
Denver, Colorado, 80401
Study site
Grand Rapids, Michigan, 49546
Study site
Leawood, Kansas, 66211
Study site
Philadelphia, Pennsylvania, 19107
Study site
Portland, Oregon, 97239
Study site
Royal Oak, Michigan, 48073
Study site
San Francisco, California, 94109
About this study
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
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.
- Conditions
- Uveal Melanoma, Choroid Neoplasm
- Being tested
- ICON-1
- Medical subject headings
- Uveal Melanoma, Choroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICON-1Biological
Also called human Immuno-conjugate 1
Intravitreal injection of ICON-1
| Study group | Role | What they receive |
|---|---|---|
| ICON-1 0.3 mg Singe Dose | Experimental | Patients will receive a single intravitreal dose of ICON-1 0.3 mg Receives: 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 Receives: 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 Receives: Biological: ICON-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events
Measured: 30 days (plus or minus 5 days) after surgical procedure
Secondary outcomes (2)
Changes in Plasma Levels of ICON-1.
Measured: Baseline to 1 day after last dose of ICON-1
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.
Measured: Baseline to on or 1 day prior to surgical procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iconic Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriela Burian, MD, Study director, Iconic Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771340
- Sponsor's protocol ID
- IT-003
- Status last verified
- Sep 2020
- First submitted
- 6 May 2016
- Last updated
- 1 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02771340
- Acronym / sponsor ID
- IT-003
- Conditions
- Uveal Melanoma, Choroid Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Iconic Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICON-1 0.3 mg Singe Dose | Experimental | Biological: ICON-1Patients will receive a single intravitreal dose of ICON-1 0.3 mg |
| ICON-1 0.3 mg Repeat Dosing | Experimental | Biological: ICON-1Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart |
| ICON-1 0.6 mg Repeat Dosing | Experimental | Biological: ICON-1Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICON-1Also: human Immuno-conjugate 1Intravitreal injection of ICON-1 | Biological | ICON-1 0.3 mg Repeat Dosing, ICON-1 0.3 mg Singe Dose, ICON-1 0.6 mg Repeat Dosing |
Primary outcome
Occurrence of Adverse Events
Time frame: 30 days (plus or minus 5 days) after surgical procedure
2 secondary outcomes
Changes in Plasma Levels of ICON-1.
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CURE OM (Community United for Research and Education of Ocular Melanoma)Link provided by the sponsor.
- Ocular Melanoma Foundation (OMF)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Burian, MD study director
Iconic Therapeutics, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICON-1 in people with Uveal Melanoma and Choroid Neoplasm, run by Iconic Therapeutics, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Adverse Events (time frame: 30 days (plus or minus 5 days) after surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.