MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) (C-PRECISE-01)

  • End date
    Jul 24, 2023
  • participants needed
  • sponsor
    Menarini Group
Updated on 24 March 2022
measurable disease
adenocarcinoma of colon


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.


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.

Condition Metastatic Colorectal Cancer
Treatment Cetuximab, MEN1611
Clinical Study IdentifierNCT04495621
SponsorMenarini Group
Last Modified on24 March 2022


Yes No Not Sure

Inclusion Criteria

Histological documentation of adenocarcinoma of the colon or rectum
Progression or recurrence following prior irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens for metastatic disease
Best response according to Response Evaluation Criteria in Solid Tumours criteria to the last anti-EGFR containing regimen of partial response or stable disease for at least 4 months
Measurable disease according to RECIST criteria
N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria

Previous treatment with PI3K inhibitor
Brain metastases, unless treated > 4 weeks before Screening Visit and only if clinically stable and not receiving corticosteroids
NCI CTCAE v5.0 Grade ≥ 2 diarrhoea
History of significant, uncontrolled or active cardiovascular disease
Known active or uncontrolled pulmonary dysfunction
Uncontrolled diabetes mellitus (HbA1c > 7%) and fasting plasma glucose > 126 mg/dL
Known history of human immunodeficiency virus infection or active infection with hepatitis C virus or hepatitis B virus
Concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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