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Actinium-225 clinical trials

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NCT ID: NCT03746431 Recruiting - Clinical trials for Advanced Solid Tumours

A Phase 1 Study of [225Ac]-FPI-1434 Injection

Start date: January 17, 2019
Phase: Phase 1
Study type: Interventional

This is a first-in-human phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumour activity of [111In]-FPI-1547 Injection (radioimmuno-imaging agent) and [225Ac]-FPI-1434 Injection (radioimmuno-therapeutic) and to establish the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of repeat doses of [225Ac]-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of [111In]-FPI-1547. The study consists of a dose escalation portion, including both single and multi-dosing cohorts, of approximately five cohorts and a cold antibody sub-study portion of up to three cohorts.