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BRAF V600 Colorectal CancerPhase 2NCT07150247

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

A Phase 2 study testing Iparomlimab and Tuvonralimab, Bevacizumab and 5-Fluorouracil in people with BRAF V600 Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
BRAF V600 Colorectal Cancer
What is being tested?
Iparomlimab and Tuvonralimab, Bevacizumab and 5-Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Jun 2025to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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
  • Expected survival > 3 months
  • Signed written informed consent
  • Willing and able to comply with follow-up until death, study completion, or study termination
  • For women of childbearing potential: Negative serum pregnancy test within 14 days prior to treatment; Willing to use medically accepted contraception during the study and for 3 months after the last dose
  • For male participants with partners of childbearing potential: Must have undergone surgical sterilization, or use effective contraception during the study and for 3 months after the last dose

Who cannot join

  • 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
Show all 33Show fewer
  • 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
  • Chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory, immunosuppressive therapy, or surgery) within 12 months prior to enrollment
  • Gastrointestinal disorders that may significantly affect oral drug absorption (e.g., severe GI ulcers, uncontrolled vomiting, malabsorption syndrome, short bowel syndrome)
  • Neuromuscular diseases associated with elevated CK (e.g., inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
  • Residual ≥Grade 2 toxicity from prior anti-tumor therapy (excluding ≥Grade 2 alopecia or neuropathy)
  • History of HIV infection
  • History of Gilbert's syndrome
  • Interstitial pneumonia or extensive symptomatic interstitial pulmonary fibrosis
  • Severe uncontrolled systemic comorbidities
  • Severe cardiovascular disease, including:
  • Stroke within 6 months prior to enrollment
  • Myocardial infarction within 6 months prior to enrollment
  • Hypertension not controlled with appropriate medications
  • Unstable angina
  • Congestive heart failure (NYHA class 2-4)
  • Cardiac arrhythmias requiring treatment
  • Current or prior central nervous system disease, including: Primary brain tumor; Epilepsy not controlled by standard treatment; Any brain metastases or history of stroke
  • Other uncontrolled comorbidities, including active bleeding, uncontrolled infection or non-malignant medical conditions that could be worsened by study therapy, or uncontrolled psychiatric/social conditions
  • History of other malignancies within the past 5 years (except for curatively treated basal cell carcinoma, cervical carcinoma in situ, or thyroid cancer)
  • Allergy to any study drug
  • Pregnant or breastfeeding women
  • Women of childbearing potential (last menstrual period <2 years) or men who refuse to use effective non-hormonal contraception (IUD, barrier method plus spermicide, or sterilization)
  • Inability or unwillingness to comply with study protocol
  • Any other disease, metastatic lesion-related functional impairment, or suspicious findings on physical examination that may indicate contraindication to study drug use or place the patient at high risk of treatment-related complications.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Deshen Wang, PhD contact

87342487 ext. 020

wangdsh@sysucc.org.cn

Ruihua Xu, PhD contact

87342479 ext. 020

xurh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Deshen Wang, PhD, 87342487 ext. 020, wangdsh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer

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?

Read more

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

Read the 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.

Being tested
Iparomlimab and Tuvonralimab, Bevacizumab, 5-Fluorouracil, Irinotecan (drug)
Keywords
Objective response rate, Circulating tumor DNA, Phase II clinical trial, BRAF V600E colorectal cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iparomlimab and TuvonralimabDrug

    Also called QL1706

    3mg/kg，ivdrip

  • BevacizumabDrug

    Also called Avastin

    5mg/kg，ivdrip

  • 5-FluorouracilDrug

    Also called 5-FU

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

  • Irinotecan (drug)Drug

    Also called CPT-11

    180mg/m2

Study groups in NCT07150247
Study groupRoleWhat they receive
Iparomlimab and Tuvonralimab+ Bevacizumab + FOLFIRIExperimentalGiven every two weeks
Receives: Drug: Iparomlimab and Tuvonralimab; Drug: Bevacizumab; Drug: 5-Fluorouracil; Drug: Irinotecan (drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    The percentage of patients in a study group who have a partial or complete response to treatment according to RECIST v1.1 criteria

    Measured: 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

Secondary outcomes (3)

  1. Progression Free Survival

    The proportion of patients who remain alive and whose disease does not progress after starting treatment

    Measured: Assessed throughout the study duration (3 years)

  2. Overall survival

    Time from treatment initiation to death from any cause or censored due to loss to follow up

    Measured: Assessed throughout the study duration (5 years)

  3. Adverse events

    Assessment of adverse events and their severity according to NCI CTCAE version 5.0 criteria

    Measured: Assessed throughout the study duration (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2025
  2. Study start1 Jun 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospecitve Single arm study
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07150247
Sponsor's protocol ID
IB-FOLFIRI
Status last verified
Sep 2025
First submitted
25 Aug 2025
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data and materials used in this study can be made available following study completion upon reasonable request to the corresponding author, subject to ethical and legal considerations and applicable data-sharing agreements.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iparomlimab and Tuvonralimab, Bevacizumab and 5-Fluorouracil in people with BRAF V600 Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Deshen Wang, PhD (87342487 ext. 020, wangdsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07150247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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