About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.