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

NCT04495621 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-05-01

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Josep Tabernero, MD, PhD · Vall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2024-01-12
Completion
2024-02-27
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495621 on ClinicalTrials.gov