A Phase 1 Study of [225Ac]-FPI-1434 Injection
Summary
This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of \[225Ac\]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent), 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 (radioimmuno-imaging agent).
Timeline
- Start
- 2019-01-17
- Primary completion
- 2025-12-03
- Completion
- 2025-12-03
Outcome
Met primary endpoint
Stopped (Business): “A strategic decision was made to discontinue the study and prioritize other programs within the portfolio. The study was not discontinued due to safety issues or adverse events related to FPI-1434, FPE-1547, or FPI-1175.”
release “[225Ac]-FPI-1434 demonstrated a manageable safety profile with no drug-related serious adverse events and/or dose limiting toxicity in administered activity up to 40 kBq/kg body-weight.” fusionpharma.com ↗
Publications
- Anderson PM, Subbiah V, Trucco MM. Current and future targeted alpha particle therapies for osteosarcoma: Radium-223, actinium-225, and thorium-227. Front Med (Lausanne). 2022 Nov 15;9:1030094. doi: 10.3389/fmed.2022.1030094. eCollection 2022.
- Martiniova L, Zielinski RJ, Lin M, DePalatis L, Ravizzini GC. The Role of Radiolabeled Monoclonal Antibodies in Cancer Imaging and ADC Treatment. Cancer J. 2022 Nov-Dec 01;28(6):446-453. doi: 10.1097/PPO.0000000000000625.