Phase 1 dose escalation and expansion of AB001 in patients with metastatic castration resistant prostate cancer (mCRPC): The ARTISAN trial
Abstract
TPS289
Background:
Treatment options for patients with mCRPC have been improved by radioligand therapies such as beta-emitting
177
Lu-PSMA-617. However, prostate cancer remains the fifth leading cause of cancer mortality, with the lives of more than 250,000 men shorted by mCRPC each year. New therapies with differentiated mechanisms of action that could extend survival while retaining quality of life are needed. Alpha-particle emitting radioisotopes offer significant advantages compared with beta-emitters. Alpha particles have higher atomic mass (4), charge (2+), and linear energy transfer. Furthermore, the short particle range (<100 µm) is expected to minimize damage to surrounding normal tissue.
212
Pb is attractive for alpha radiotherapeutics due to its short 10.6 hour half-life which fits well with the rapid tumor uptake achievable with PSMA-targeting small molecules. The ARTISAN trial is a Dose Escalation Expansion study of AB001, a
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Pb-labelled, PSMA-targeted small molecule alpha-radiotherapeutic.
Methods:
This is a Phase 1, open-label, multicentre study in patients with advanced PSMA-positive mCRPC. Participants must have received previous treatment with at least one androgen receptor pathway inhibitor and at least one prior taxane. The study will evaluate the safety and tolerability of AB001 in two populations: participants with mCRPC who have not received prior treatment with
177
Lu-PSMA radioligand therapy and participants who have been treated with at least one…
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