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

Sponsor
Sun Yat-sen University
Study ID
NCT07150247
Phase
PHASE2
Status
Recruiting
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Conditions

  • BRAF V600 Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Iparomlimab and Tuvonralimab — DRUG
    3mg/kg，ivdrip
  • Bevacizumab — DRUG
    5mg/kg，ivdrip
  • 5-Fluorouracil — DRUG
    400mg/m2 iv followed by 2.4g/m2 civ 48h
  • Irinotecan (drug) — DRUG
    180mg/m2

Study Details

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

Key Dates

Start date
Jun 1, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iparomlimab and Tuvonralimab+ Bevacizumab + FOLFIRI
    Given every two weeks

Primary Outcome Measure

Objective Response Rate [ Time Frame: Assessed after every 4 cycles (each cycle is 2 weeks) from treatment initiation until radiographic disease progression, treatment discontinuation, or completion of the 3-year follow-up, whichever occurs first ]

Central Contacts