|Étape du traitement :||Traitements combinés|
|Date d'ouverture :||20/07/2020|
|Date clôture :||01/01/2024|
|Promoteur :||Menarini Group|
|Progression du cancer:||Loco-régional et à distance|
This Phase Ib/II study will investigate the anti-tumour activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male patients affected by PIK3CA mutated, N-K-RAS wild-type and BRAF wild-type metastatic colorectal cancer.
MEN1611 is a potent, selective Class I phosphoinositide 3-kinase (PI3K) inhibitor. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors.
This Phase Ib/II will start with a dose confirmation part (Step 1) to identify the RP2D of MEN1611 given in combination with cetuximab.
The study will continue with a cohort expansion (Step 2) to explore the anti-tumour activity of the selected MEN1611 dose level combined with cetuximab with further assessment of their safety and tolerability.
- Cancers digestifs
- Tumeur maligne du côlon - Cim10 : C18
- Tumeur maligne du rectum - Cim10 : C20