Advanced Solid Tumours Clinical Trial
Official title:
A Cancer Research UK Phase I Study to Determine the Maximum Tolerated Dose of the Oral Src/Abl Inhibitor AZD0424, and to Identify Tolerable and Effective AZD0424 Combination Regimens for the Treatment of Advanced Solid Tumours
The purpose of this study is to determine the maximum tolerated dose of the oral Src/Abl inhibitor AZD0424, and to find tolerable and effective AZD0424 combination regimens for the treatment of advanced solid tumours
AZD0424 is a potent orally available, potent (IC50 approximately 4 nM) inhibitor of Src and
ABL1 kinases with additional activity against Src family kinase (SFK) members including Yes
and Lck. AZD0424 was selective for SFKs and ABL1 kinase over C-terminal Src kinase (a
negative regulator of Src) and a range of other kinase targets. The anti-cancer activity of
AZD0424 is thought to be mediated primarily by anti-migratory and anti-invasive signalling
and, as such, it is expected that in the late stage cancer setting strong signals of efficacy
with this compound used as a single agent are unlikely, requiring it to be administered in
combination with other anti-cancer agents.
In summary the study will be performed in four main stages:
- AZD0424 monotherapy, dose escalation: Phase Ia single agent (AZD0424) dose escalation
study to determine the MTD.
- AZD0424 monotherapy, dose expansion: Phase Ib single agent dose expansion at MTD (up to
six additional patients may be recruited in order to provide paired tumour biopsies for
PD analysis).
- Combination arm dose escalation: Provided that it is deemed appropriate (after review of
available clinical data from the monotherapy part of the trial, and available
preclinical and published data on the combination), a Phase Ia dose escalation arm of
AZD0424 in combination with the selected agent will proceed to determine the MTD for the
combination and a recommended Phase II dose.
- Combination arm dose expansion: Phase Ib combination arm using the recommended Phase II
dose for both AZD0424 and the combination agent.
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