Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer
A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer
Sun Yat-sen University
20 participants
Jun 1, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if Iparomlimab and Tuvonralimab combined with bevacizumab and FOLFIRI (IB-FOLFIRI) is safe and effective in treating adults with BRAF V600E-mutant metastatic colorectal cancer (mCRC). The main questions it aims to answer are: Does IB-FOLFIRI improve clinical outcomes compared with historical outcomes in this population? What is the safety profile of IB-FOLFIRI in patients with BRAF V600E-mutant mCRC? Participants will: Receive Iparomlimab and Tuvonralimab, bevacizumab, and FOLFIRI every two weeks Have blood samples and/or tumor tissue collected for biomarker analysis (e.g., ctDNA sequencing) Undergo regular imaging and clinical evaluations to assess treatment response and safety
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
3mg/kg,ivdrip
5mg/kg,ivdrip
400mg/m2 iv followed by 2.4g/m2 civ 48h
180mg/m2
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07150247