Open-label, Multicentre, Phase Ib/II Study of MEN1611, a PI3K Inhibitor, and Cetuximab in Patients With PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens

MEN1611-02

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.

2020-07-20

2024-06-01

2024-06-01

Active (not recruiting)

Early phase I

29

Main 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. Main 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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2024-01-22