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OncoMatch/Clinical Trials/NCT05496686

Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma

Is NCT05496686 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for uveal melanoma.

Phase 1RecruitingModulation Therapeutics, Inc.NCT05496686Data as of May 2026

Treatment: 4.7 microCi 225Ac-MTI-201 · 9.5 microCi of 225Ac-MTI-201 · 19 microCi of 225Ac-MTI-201 · 38 microCi of 225Ac-MTI-201 · 76 microCi of 225Ac-MTI-201 · 152 microCi of 225Ac-MTI-201 · 254 microCi of 225Ac-MTI-201 · 424 microCi of 225Ac-MTI-201 · 564 microCi of 225Ac-MTI-201 · 750 microCi of 225Ac-MTI-201 · 998 microCi of 225Ac-MTI-201 · 1327 microCi of 225Ac-MTI-201The primary aim of the study is to establish the maximum-tolerated dose (MTD) of 225Ac-MTI-201 in participants with metastatic uveal melanoma. The secondary aims are to describe the pharmacokinetics of 225Ac-MTI-201 and the toxic effects of 225Ac-MTI-201 in participants with metastatic uveal melanoma.

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Extracted eligibility criteria

Cancer type

Melanoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: any prior therapy for metastatic uveal melanoma — metastatic

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.

Cannot have received: alpha-particle therapy

Prior alpha-particle therapy.

Cannot have received: external beam radiation therapy to more than 25 percent of the bone marrow

Prior external beam radiation therapy to more than 25 percent of the bone marrow.

Lab requirements

Blood counts

Leucocytes ≥ 3,000/μL; Absolute neutrophil count ≥ 1,500/μL; Platelets ≥ 100,000/μL

Kidney function

Creatinine clearance ≥ 60mL/min/1.73m^2 (Cockcroft-Gault equation, adjusted for BSA)

Liver function

AST/ALT ≤ 2.5x institutional ULN; Bilirubin ≤ 1.5x institutional ULN

Leucocytes ≥ 3,000/μL; Absolute neutrophil count ≥ 1,500/μL; Platelets ≥ 100,000/μL; AST/ALT ≤ 2.5x institutional ULN; Bilirubin ≤ 1.5x institutional ULN; Creatinine clearance ≥ 60mL/min/1.73m^2 (Cockcroft-Gault equation, adjusted for BSA)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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