Radioactive drug trial aims at rare eye cancer
NCT ID NCT05496686
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a radioactive drug called 225Ac-MTI-201 in 16 people with metastatic uveal melanoma, a rare eye cancer that has spread to other parts of the body. The main goal is to find the highest safe dose and understand side effects. Participants receive a single IV dose, and researchers monitor for toxicities and how the drug leaves the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 225Ac-MTI-201 (a radioactive drug given by IV)
- What this could lead to
- If it works, this could point toward a new treatment option for metastatic uveal melanoma, a rare eye cancer that has spread.
- What could go wrong
- This is a very early, small Phase 1 trial with only 16 people. The main goal is safety, not effectiveness. The radioactive drug may cause serious side effects, and it is unknown if it will shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed metastatic uveal melanoma. * Progression after at least one prior line of therapy for metastatic uveal melanoma. Liver directed therapy (e.g., hepatic arterial embolization, isolated hepatic perfusion) will count as one line of therapy. Should any additional treatment(s) receive regulatory approval for metastatic uveal melanoma during the conduct of this trial, participants (if eligible for the newly approved treatment) would need to demonstrate disease progression on the additional treatment(s) before being eligible to participate in the current study. There is no limit to the number of previous treatments for metastatic disease. * Participants must have measurable disease per RECIST 1.1. * Adults, age 18 or over, with no upper age limit. * ECOG (Eastern Cooperative Oncology Group) performance status of 0-1 (Karnofsky ≥ 70 percent). * Acceptable organ and marrow function as defined below: * Leucocytes ≥ 3,000/μL * Absolute neutrophil count ≥ 1,500/μL * Platelets ≥ 100,000/μL * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ≤ 2.5x institutional upper limit of normal (ULN) * Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) * Creatinine clearance ≥ 60mL/min/1.73m\^2 (measured by Cockcroft-Gault equation using actual body weight in kilograms, and then adjusted for body surface area) * Male participants who are sexually active, and female participants of childbearing potential must agree to use 2 forms of FDA approved contraceptive methods during treatment with 225Ac-MTI-201 and up to 3 months following treatment. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior alpha-particle therapy. * Has known symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable without evidence of progression by imaging for at least four weeks after definitive intervention and using no more than the equivalent of dexamethasone 2 mg/d for the management of vasogenic edema, if necessary. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability. * Participants with an active malignancy requiring anticancer treatment at the time of study entry that, in the judgment of the investigator could impact the results of treatment of metastatic uveal melanoma. * Pregnant or nursing women. Women of childbearing potential (defined as having had a menstrual cycle within the past 12 months, and not having had a surgical procedure for sterilization) must have a negative pregnancy test (urine or serum) within 7 days of treatment with 225Ac-MTI-201. * Participants with uncontrolled inter-current illness including, but not limited to, ongoing or active bacterial infection, active hepatitis B/C infection requiring antiviral therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Immunocompromised participants may be at increased risk of toxicity. Therefore, HIV-positive participants, participants with acquired or congenital immunodeficiency conditions, those on chronic systemic corticosteroids requiring \>10 mg of prednisone or equivalent per day will be excluded from participation. (Participants with autoimmune disease who do not require corticosteroids or are maintained on ≤10 mg of prednisone or equivalent per day ARE eligible for participation; for participants with CNS metastases on steroids, exclusion criterion bullet point #2 above will apply). * Prior external beam radiation therapy to more than 25 percent of the bone marrow.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can flooding the liver with chemotherapy stop ocular melanoma?
- Liver-Targeted immune cell attack tested against melanoma spread
- Can a pill combo keep uveal melanoma from coming back?
- Can a platform trial match the right drug combo to each tumor?
- Can tracking a rare eye cancer pave the way for new treatments?
- Can a new drug tame advanced solid tumors?