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

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: Cetuximab

Criteria

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 at least stable disease for 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.

• Previous treatment with an anti-EGFR containing regimen for metastatic disease within 6 months prior to inclusion into the study.

• Untreated brain metastases, unless treated > 4 weeks earlier 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.