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Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07150247•Sun Yat-sen University

View on ClinicalTrials.gov

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

Detailed Description

This is a single-arm, phase II clinical trial designed to evaluate the safety and efficacy of Iparomlimab and Tuvonralimab plus bevacizumab combined with FOLFIRI (IB-FOLFIRI) in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). Patients with this genetic subtype have limited treatment options and a poor prognosis, underscoring the urgent need for more effective therapeutic strategies. This study will generate prospective clinical data on the efficacy and safety of the IB-FOLFIRI regimen in a genetically defined subgroup of colorectal cancer. Furthermore, exploratory biomarker analyses may provide new insights into resistance mechanisms, potentially guiding future precision-medicine strategies for BRAF V600E-mutant mCRC.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years and ≤75 years
•Histologically confirmed metastatic colorectal adenocarcinoma
•BRAF V600E mutation confirmed by tissue pathology or ctDNA testing (PCR or NGS)
•Disease progression after at least one line of treatment: FOLFOX/XELOX (oxaliplatin-based doublet) ± bevacizumab or FOLFOXIRI (irinotecan-based triplet) ± bevacizumab. Note: Irinotecan must not have failed during prior treatment, and disease must not have progressed within three months of stopping treatment
•Patients who have received first-line treatment with cetuximab combined with a BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib) are allowed
•At least one measurable lesion according to RECIST v1.1 criteria
•Adequate hematologic unction: Platelets \> 90 × 10⁹/L; Hemoglobin \> 100 g/L; White blood cells \> 3 × 10⁹/L; Neutrophils \> 1.5 × 10⁹/L; Adequate liver function; Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases present); Alkaline phosphatase ≤ 2.5 × ULN; No ascites; Coagulation: PT ≤ 1.5 × ULN, INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN, Albumin ≥ 30 g/L
•Adequate renal function: CrCl ≥ 50 mL/min or serum creatinine ≤ 1.5 × ULN
•Liver function Child-Pugh class A
•ECOG performance status 0-1
+5 more criteria

Exclusion Criteria

•KRAS or NRAS mutation
•MSI-H/dMMR patients
•Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors
•Known contraindications to irinotecan at the planned dose
•Use of systemic immunosuppressive drugs within 1 week prior to treatment
•Active autoimmune disease requiring treatment, or history of such disease within the past 2 years
•Known primary immunodeficiency
•History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
•Retinal vein occlusion or risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or high intraocular pressure)
•History of acute or chronic pancreatitis
+23 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

June 1, 2025

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2028

Last Updated

September 26, 2025

Enrollment

ESTIMATED participants

Conditions

BRAF V600 Colorectal Cancer

Interventions

Iparomlimab and Tuvonralimab

DRUG

Bevacizumab

DRUG

5-Fluorouracil

DRUG

Irinotecan (drug)

DRUG

Contacts

Deshen Wang, PhD

CONTACT

87342487 wangdsh@sysucc.org.cn

Ruihua Xu, PhD

CONTACT

87342479 xurh@sysucc.org.cn

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

NCT04294160

BRAF V600 Colorectal Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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