Type : | Industriel |
Statut : | Ouvert |
Phase : | I |
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
- Colon
- Rectum
- PIK3CA
- Tumeur maligne du côlon - Cim10 : C18
- Tumeur maligne du rectum - Cim10 : C20