Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma
NCT05496686 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-04-03
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.
Conditions
- Uveal Melanoma
- Metastatic
Interventions
- DRUG
-
4.7 microCi 225Ac-MTI-201
4.7 microCi intravenous solution
- DRUG
-
9.5 microCi of 225Ac-MTI-201
9.5 microCi intravenous solution
- DRUG
-
19 microCi of 225Ac-MTI-201
19 microCi intravenous solution
- DRUG
-
38 microCi of 225Ac-MTI-201
38 microCi intravenous solution
- DRUG
-
76 microCi of 225Ac-MTI-201
76 microCi intravenous solution
- DRUG
-
152 microCi of 225Ac-MTI-201
152 microCi intravenous solution
- DRUG
-
254 microCi of 225Ac-MTI-201
254 microCi intravenous solution
- DRUG
-
424 microCi of 225Ac-MTI-201
424 microCi intravenous solution
- DRUG
-
564 microCi of 225Ac-MTI-201
564 microCi intravenous solution
- DRUG
-
750 microCi of 225Ac-MTI-201
750 microCi intravenous solution
- DRUG
-
998 microCi of 225Ac-MTI-201
998 microCi intravenous solution
- DRUG
-
1327 microCi of 225Ac-MTI-201
1327 microCi intravenous solution
Sponsors & Collaborators
-
H. Lee Moffitt Cancer Center and Research Institute
collaborator OTHER -
Modulation Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Mark L McLaughlin · Modulation Therapeutics, Inc.
-
Nikhil I Khushalani, MD · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-21
- Primary Completion
- 2027-03-31
- Completion
- 2029-02-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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