MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
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- STATUS
- Recruiting
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- End date
- Jul 27, 2023
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- participants needed
- 42
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- sponsor
- Menarini Group
Summary
Open-label, dose-confirmation and cohort expansion, multicentre, Phase Ib/II study to assess the anti-tumour activity and safety of MEN1611 in combination with cetuximab for the treatment of patients with PIK3CA mutated metastatic colorectal cancer.
Description
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.
Details
| Condition | Metastatic Colorectal Cancer |
|---|---|
| Treatment | Cetuximab, MEN1611 |
| Clinical Study Identifier | NCT04495621 |
| Sponsor | Menarini Group |
| Last Modified on | 27 January 2021 |
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