RecruitingPhase 2NCT07150247

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


Sponsor

Sun Yat-sen University

Enrollment

20 participants

Start Date

Jun 1, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination chemotherapy regimen called IB-FOLFIRI for people with metastatic colorectal cancer that has a specific genetic mutation called BRAF V600E. This mutation makes standard treatments less effective, and researchers are looking for better options. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed metastatic colorectal cancer with a BRAF V600E mutation (confirmed by tissue or blood test) - Your cancer has progressed after at least one prior treatment (oxaliplatin-based chemotherapy) - Irinotecan has not previously failed in your treatment - You have at least one measurable tumor - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have received irinotecan before and your cancer progressed on it - You have significant organ dysfunction or serious health conditions that make chemotherapy unsafe Talk to your doctor to see if this trial is right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIparomlimab and Tuvonralimab

3mg/kg,ivdrip

DRUGBevacizumab

5mg/kg,ivdrip

DRUG5-Fluorouracil

400mg/m2 iv followed by 2.4g/m2 civ 48h

DRUGIrinotecan (drug)

180mg/m2


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07150247