drugset / Trial / NCT07150247
Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |