Actively Recruiting
Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Led by Shanghai Kechow Pharma, Inc. · Updated on 2025-09-18
165
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, open-label, Phase 3 study
CONDITIONS
Official Title
Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before study procedures
- Male or female aged 18 to 70 years
- Diagnosed with metastatic colorectal cancer confirmed by histology or cytology
- Tumor with BRAFV600E mutation confirmed by local or central testing
- Ability to provide sufficient tumor tissue for confirmatory BRAF testing
- Disease progression after one or more prior metastatic treatments
- At least one measurable tumor site by RECIST 1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Ability to swallow medication
- Adequate blood, kidney, heart, and liver function within 7 days before dosing
- Willing and able to complete all study procedures and follow-up
You will not qualify if you...
- Prior treatment with any BRAF or MEK inhibitor
- Known contraindications to control arm treatment
- Symptomatic brain metastases or leptomeningeal disease
- Recent (within 12 months) chronic inflammatory bowel disease or Crohn's disease requiring medical treatment
- History of acute or chronic pancreatitis
- Uncontrolled gastrointestinal issues affecting drug absorption
- Serious cardiovascular disease or events within 6 months before study treatment
- History or risk factors for retinal vein occlusion
- Neuromuscular disorders linked to elevated creatine kinase
- Uncontrolled blood pressure despite treatment
- Other cancers within 5 years except certain cured or noninvasive types
- Residual severe toxicity from prior anticancer therapies (except alopecia or neuropathy)
- Active infections including HIV, syphilis, hepatitis B or C
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Oncology Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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