NCT04495621

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label, dose-confirmation and cohort expansion, multicenter, Phase Ib/II study to assess the anti-tumor activity and safety of MEN1611 in combination with cetuximab for the treatment of participants with phosphatidylinositol 3-kinase, catalytic, alpha polypeptide gene (PIK3CA)-mutated metastatic colorectal cancer.

Detailed description

This Phase Ib/II study investigated the anti-tumor activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male participants affected by PIK3CA-mutated, neuroblastoma-Kristen-rat sarcoma virus (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 of MEN1611 given as single agent was assessed in a Phase I trial in participants with advanced solid tumors. This Phase Ib/II started with a dose confirmation part (Step 1) to identify the recommended phase 2 dose of MEN1611 given in combination with cetuximab. The study continued with a cohort expansion (Step 2) to explore the anti-tumor activity of the selected MEN1611 dose level combined with cetuximab with further assessment of safety and tolerability.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	MEN1611	MEN1611 oral dose administered twice daily for a continuous 28-day cycle.
DRUG	Cetuximab	Cetuximab solution for infusion administered weekly via intravenous infusion.

Timeline

• Start date: 2020-07-20
• Primary completion: 2024-01-12
• Completion: 2024-02-27
• First posted: 2020-08-03
• Last updated: 2025-05-01
• Results posted: 2025-05-01

Locations

28 sites across 7 countries: United States, France, Germany, Italy, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study