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

Main Inclusion Criteria:

1. Histological documentation of adenocarcinoma of the colon or rectum.
2. Progression or recurrence following prior irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens for metastatic disease.
3. 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.
4. Measurable disease according to RECIST criteria.
5. N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Main Exclusion Criteria:

1. Previous treatment with PI3K inhibitor.
2. Brain metastases, unless treated > 4 weeks before Screening Visit and only if clinically stable and not receiving corticosteroids.
3. NCI CTCAE v5.0 Grade ≥ 2 diarrhoea.
4. History of significant, uncontrolled or active cardiovascular disease.
5. Known active or uncontrolled pulmonary dysfunction.
6. Uncontrolled diabetes mellitus (HbA1c > 7%) and fasting plasma glucose > 126 mg/dL.
7. Known history of human immunodeficiency virus infection or active infection with hepatitis C virus or hepatitis B virus.
8. Concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents.