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NCT05496686

Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma

Active, enrolled Phase 1 Last updated 3 April 2026
What this trial tests

Phase 1 trial testing 4.7 microCi 225Ac-MTI-201 in Uveal Melanoma in 16 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
21 July 2022
Primary endpoint
31 March 2027
25 February 2029

Quick facts

Lead sponsorModulation Therapeutics, Inc.
PhasePhase 1
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment16
Start date21 July 2022
Primary completion31 March 2027
Estimated completion25 February 2029
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Modulation Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Uveal Melanoma or Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Development of radiopharmaceuticals for targeted alpha therapy: Where do we stand?
    Pallares RM, Abergel RJ. · · 2022 · cited 31× · PMID 36619636 · DOI 10.3389/fmed.2022.1020188
  2. Actinium-225 Targeted Agents: Where Are We Now?
    Mourtada F, Tomiyoshi K, Sims-Mourtada J, Mukai-Sasaki Y, et al · · 2023 · cited 14× · PMID 37690972 · DOI 10.1016/j.brachy.2023.06.228
  3. State-of-the-art in Metastatic Uveal Melanoma Treatment: A 2025 Update : How to treat Metastatic Uveal Melanoma in 2025.
    Ziogas DC, Foteinou D, Theocharopoulos C, Martinos A, et al · · 2025 · cited 9× · PMID 40380030 · DOI 10.1007/s11912-025-01684-0
  4. Targeted alpha therapy: a comprehensive analysis of the biological effects from "local-regional-systemic" dimensions.
    Song Z, Zhang J, Qin S, Luan X, et al · · 2025 · cited 7× · PMID 40498155 · DOI 10.1007/s00259-025-07390-0
  5. How we treat patients with metastatic uveal melanoma.
    Saldanha EF, Ribeiro MF, Hirsch I, Spreafico A, et al · · 2025 · cited 7× · PMID 40112696 · DOI 10.1016/j.esmoop.2025.104496
  6. Melanocortin-1 Receptor Expression as a Marker of Progression in Melanoma.
    Su DG, Djureinovic D, Schoenfeld D, Marquez-Nostra B, et al · · 2024 · cited 7× · PMID 38662983 · DOI 10.1200/po.23.00702
  7. Radioligand Therapy in Cancer Management: A Global Perspective.
    Ninatti G, Lee ST, Scott AM. · · 2025 · cited 5× · PMID 41228206 · DOI 10.3390/cancers17213412
  8. Resolution Pharmacology: State-of-the-art and therapeutic landscape.
    Perretti M, Montero-Melendez T. · · 2025 · cited 1× · PMID 41205263 · DOI 10.1016/j.pharmr.2025.100097

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