The first in human study of 225Actinium-MTI-201 (225Ac-MTI-201) in metastatic uveal melanoma
The research company Modulation Therapeutics, Inc is conducting the clinical trial Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma.
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.
It is planned to include 16 participants.
Actual study start date is July 21, 2022. The researchers expect to complete the study by February 25, 2029.
One primary outcome measure is The Number of Participants Who Experienced Serious or Non-Serious Adverse Events, Vital signs, physical examination, 12-lead EKG, and blood including toxicity on Days 8, 15, 22, and 29: Week 9, Follow-Up (Starting in Week 17) Adverse Event (AE), any new untoward medical occurrence or worsening of a preexisting medical condition in Participant administered study drug and that may or may not have a causal relationship with drug treatment. All AEs will be graded using the NCI CTCAE v5.0 criteria. Serious Adverse Event (SAE); an untoward medical occurrence at any dose that: Results in death; Is life-threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Is an important medical event that may not be immediately life- threatening or result in death or hospitalization but, may jeopardize the participant or may require intervention to prevent one of the other serious outcomes; or, potential drug induced liver injury (DILI).
Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05496686.
