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Tests treatment safety and results for BRAF V600 Colorectal Cancer
Official title Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07150247
What this study is testing
What is Iparomlimab and Tuvonralimab?
Iparomlimab and Tuvonralimab is an investigational medicine, being studied as a potential treatment for braf v600 colorectal cancer.
Also referred to as QL1706.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Patients who have received first-line treatment with cetuximab combined with a BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib) are allowed
You likely can't join if
- 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
See the full eligibility 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...
- 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 (≤...
- 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
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.