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New treatment option for BRAF V600E
Official title A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07506109
What this study is testing
What is Ipilimumab N01?
Ipilimumab N01 is an investigational medicine, being studied as a potential treatment for braf v600e.
Also referred to as IBI-310.
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
- Colorectal cancer (CRC) is the second leading cause of cancer-related death globally. BRAF V600E mutations occur in approximately 12% of metastatic CRC (mCRC) patients, conferring an extremely poor prognosis with a median overall survival (OS) of only 11 months for standard chemotherapy.
- 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 and older
You may be able to join if
- Provided written informed consent.
- Age ≥ 18 years.
- Histologically or pathologically confirmed colorectal adenocarcinoma.
- Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.
- Locally advanced unresectable disease or distant metastasis.
You likely can't join if
- Received any approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment.
- Underwent any surgery or invasive procedure within 4 weeks prior to study initiation (exceptions include venous catheter placement and...
- Multiple primary malignancies (exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ...
- Presence of severe comorbidities or serious medical conditions.
- Pregnant or breastfeeding females.
- The investigator deems the patient unsuitable for participation in this study.
See the full eligibility criteria
- Provided written informed consent.
- Age ≥ 18 years.
- Histologically or pathologically confirmed colorectal adenocarcinoma.
- Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.
- Locally advanced unresectable disease or distant metastasis.
- No prior treatment with BRAF/MEK/ERK inhibitors, EGFR inhibitors, or immune checkpoint inhibitors (ICI).
- Presence of measurable target lesions per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Adequate organ function, based on the following laboratory values obtained within 7 days prior to Cycle 1 Day 1:
- Hemoglobin ≥ 9.0 g/dL.
- Absolute neutrophil count ≥ 1,500/mm³ (≥ 1.5 × 109/L).
- Platelet count ≥ 80,000/mm³ (≥ 80 × 109/L).
- Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min.
- Willing and able to comply with study procedures and visit schedule.
- Received any approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment.
- Underwent any surgery or invasive procedure within 4 weeks prior to study initiation (exceptions include venous catheter placement and paracentesis/drainage).
- Multiple primary malignancies (exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any other cancer...
- Presence of severe comorbidities or serious medical conditions.
- Pregnant or breastfeeding females.
- The investigator deems the patient unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Wuhan, Hubei, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Chengdu, Sichuan, China; Tianjin, Tianjin Municipality, 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.