NCT05496686

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Modulation Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will enroll patients with metastatic uveal melanoma that have failed at least one form of therapy from a single academic medical center in the United States. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures. A continual reassessment method (CRM) design will be used for this clinical trial. The study proposes single patient cohorts with dose escalation starting at 4.7 microCi of 225Ac-MTI-201 after each cohort in the absence of safety concerns (2-fold increases for doses and lower dose increases between higher doses). Dose Limiting Toxicities will be assessed using the CTCAE version 5.0 criteria. The participants who meet the eligibility requirements will be administered a single intravenous dose of 225Ac-MTI-201. After study treatment, the study participants will stay overnight at the study center, undergo study procedures (i.e. vital signs, physical exam, multiple blood and urine sample collections) and will be scheduled to return to the clinic at 48 hours and for additional appointments weekly clinic visits the first month and on Week 9 for health status assessments, including physical exams, complete blood chemistry, and EKG. Tumor measurements every 8 weeks in first year post-injection; extended to 12 weeks in year 2; every 16 weeks in year 3, and 24 weeks in years 4 and 5. The clinic visits will involve seeing a study doctor plus radiological tests (such as MRI and/or CT scans) to see how the metastatic uveal melanoma has responded to the study drug. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects review board and the study will be performed in accordance with the Declaration of Helsinki.

Conditions

• Uveal Melanoma
• Metastatic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-21
• Primary completion: 2027-03-31
• Completion: 2029-02-25
• First posted: 2022-08-11
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study