drugset / Trial / NCT07150247

Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer

NCT07150247 ↗

Phase 2 Recruiting 20 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2025-06-01
Primary completion
2027-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Iparomlimab and Tuvonralimab Unknown 3 mg/kg Intravenous
Subject Irinotecan (drug) Unknown 180 mg/m2 —
Subject fluorouracil Small molecule 2.4 g Intravenous

Indications