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

Official Title

A Phase 1 Study of [225Ac]-FPI-1434 Injection in Patients With Advanced Solid Tumours

Summary:

The primary objectives are to: 1. Evaluate the safety and tolerability of [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection in patients with advanced refractory solid tumours 2. Determine the maximum tolerated dose of a single [225Ac]-FPI-1434 Injection The secondary objectives are to: 1. Obtain preliminary data on tumour uptake of [111In]-FPI-1547 Injection in cancer patients 2. Determine the dosimetry of [111In]-FPI-1547 Injection (whole body and individual organs) 3. Determine the pharmacokinetics of [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection 4. Estimate the dosimetry for [225Ac]-FPI-1434 Injection (whole body and individual regions) 5. Describe efficacy of [225Ac]-FPI-1434 Injection 6. Assess the effect of [225Ac]-FPI-1434 Injection on the QTc interval 7. Assess changes in human growth hormone (hGh), insulin-like growth factor (IGF)-1 and insulin-like growth binding protein 3 (IGFBP-3) following [111In]-FPI-1547 and [225Ac]-FPI-1434 injections

Trial Description

Primary Outcome:

• Frequency and severity of adverse events

Secondary Outcome:

• Tumour uptake of [111In]-FPI-1547 Injection in selected regions of interest on SPECT/CT images.
• Radiation doses for selected organs and whole body both for [111In]-FPI-1547 and [225Ac]-FPI-1434.
• Radiation doses for tumour lesions for [225Ac]-FPI-1434.
• Clearance for radioactivity and for the targeting antibody.
• Area under the curve (AUC) for radioactivity and for the targeting antibody.
• Cmax for radioactivity and for the targeting antibody.
• Half-life for radioactivity and for the targeting antibody.
• Objective response rate (sum of complete and partial response) per RECIST 1.1 or PCWG3 guidelines, duration of response and progression free survival.
• Changes in the QTc interval in milliseconds after [225Ac]-FPI-1434 treatment, compared to baseline.
• Changes in human growth hormone (hGh), insulin-like growth factor (IGF)-1 and insulin-like growth binding protein 3 (IGFBP-3) following [111In]-FPI-1547 and [225Ac]-FPI-1434 injections.

This is a first-in-human Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics of [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection and to establish the maximum tolerated dose of a single [225Ac]-FPI-1434 Injection in patients with solid tumours with demonstrated tumour uptake of [111In]-FPI-1547.

View this trial on ClinicalTrials.gov