Phase I study of [¹³¹I] ICF01012, a targeted radionuclide therapy, in metastatic melanoma: MELRIV-1 protocol.

ABSTRACT:

Background

Benzamide-based radioligands targeting melanin were first developed for imaging melanoma and then for therapeutic purpose with targeted radionuclide therapy (TRT). [¹³¹I]ICF01012 presents a highly favorable pharmacokinetics profile in vivo for therapy. Tumour growth reduction and increase survival have been established in preclinical models of melanoma. According the these preclinical results, we initiate a first-in-human study aimed to determine the recommended dose of [¹³¹I]ICF01012 to administer for the treatment of patients with pigmented metastatic melanoma.

Methods

The MELRIV-1 trial is an open-label, multicentric, dose-escalation phase I trial. The study is divided in 2 steps, a selection part with an IV injection of low activity of [<

SUBMITTER: Thivat E 

PROVIDER: S-EPMC9013026 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature