RecruitingPhase 1NCT05496686

Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma

First in Human Phase I Study of 225Actinium-MTI-201 (225Ac-MTI-201) in Metastatic Uveal Melanoma


Sponsor

Modulation Therapeutics, Inc.

Enrollment

16 participants

Start Date

Jul 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted alpha particle radiotherapy — a type of precision radiation that delivers intense, short-range radiation directly to cancer cells — in patients with metastatic uveal melanoma (a rare cancer that starts in the eye and commonly spreads to the liver). This cancer has very limited effective treatment options, and this approach aims to target cancer cells while sparing surrounding healthy tissue. **You may be eligible if...** - You are 18 or older with confirmed metastatic uveal melanoma - Your cancer has progressed after at least one prior treatment - You have measurable cancer on scans (per RECIST 1.1) - You are in good general health (ECOG 0–1) - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have not tried any prior treatment for metastatic uveal melanoma - Your blood counts, liver, or kidney function are below required thresholds - You have uncontrolled infections or serious medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG4.7 microCi 225Ac-MTI-201

4.7 microCi intravenous solution

DRUG9.5 microCi of 225Ac-MTI-201

9.5 microCi intravenous solution

DRUG19 microCi of 225Ac-MTI-201

19 microCi intravenous solution

DRUG38 microCi of 225Ac-MTI-201

38 microCi intravenous solution

DRUG76 microCi of 225Ac-MTI-201

76 microCi intravenous solution

DRUG152 microCi of 225Ac-MTI-201

152 microCi intravenous solution

DRUG254 microCi of 225Ac-MTI-201

254 microCi intravenous solution

DRUG424 microCi of 225Ac-MTI-201

424 microCi intravenous solution

DRUG564 microCi of 225Ac-MTI-201

564 microCi intravenous solution

DRUG750 microCi of 225Ac-MTI-201

750 microCi intravenous solution

DRUG998 microCi of 225Ac-MTI-201

998 microCi intravenous solution

DRUG1327 microCi of 225Ac-MTI-201

1327 microCi intravenous solution


Locations(1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

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NCT05496686


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