Clinical Trial

Testing Experimental Treatment for Advanced Solid Tumours

Study Description

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

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

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - [111In]-FPI-1547 Injection

[111In]-FPI-1547is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate (FPI-1397), and Indium-111.

Drug - [225Ac]-FPI-1434 Injection

[225Ac]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate (FPI-1397), and actinium-225 (225Ac or Ac-225).

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03746431

ParticipAid ID

b68Y9e