Actively Recruiting
Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer
Led by Fudan University · Updated on 2025-08-07
40
Participants Needed
1
Research Sites
344 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial evaluates Tunlametinib (MEK inhibitor) ± PD-1 in NRAS-mutant advanced thyroid cancer. Key Objectives: Assess efficacy (ORR by RECIST v1.1) Evaluate safety profiles Study Design: Single-arm, single-center 4 cohorts based on: * Histology (differentiated vs. poorly/undifferentiated) * Prior therapy status Treatment: * Cohorts 1-2: Tunlametinib monotherapy (12mg BID) * Cohorts 3-4: Tunlametinib + PD-1 (commercially available) Key Procedures: Screening: NRAS testing + full staging (CT/MRI/PET) Monitoring: q3-week labs, q9-week imaging Follow-up: 30-day safety visit + q3-month survival tracking Endpoints: Primary: ORR Secondary: Safety (CTCAE), PFS, DoR Unique Aspects: First study targeting NRAS in thyroid cancer with MEK+PD-1 Includes rare aggressive subtypes (poorly/undifferentiated)
CONDITIONS
Official Title
Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily consent to participate
- Age 18 years or older, any gender
- Diagnosed with locally advanced or recurrent/metastatic thyroid cancer not suitable for curative surgery
- Have iodine refractory thyroid cancer or differentiated thyroid cancer not suitable for iodine therapy
- Have high-grade, poorly differentiated, or undifferentiated thyroid cancer
- Confirmed NRAS mutation by genetic testing
- ECOG performance status 0 to 2
- At least one measurable tumor lesion per RECIST v1.1
- Expected survival greater than 12 weeks
- Normal organ and bone marrow function with specified blood, liver, kidney, heart, and coagulation parameters
- Negative pregnancy test for women of childbearing age and agreement to use contraception during and after the study
- Male participants agree to use contraception during and after the study
You will not qualify if you...
- Major surgery or severe trauma within 4 weeks before starting treatment (excluding minor procedures)
- Uncontrolled third-space fluid accumulation such as large pleural effusion or ascites
- Significant heart or blood vessel diseases including recent acute coronary events, symptomatic heart failure, serious arrhythmias, poorly controlled hypertension, moderate or worse valve disease, or congenital long QT syndrome
- Retinal diseases or risk factors for retinal vein occlusion
- Interstitial lung disease or clinically significant radiation pneumonitis
- Positive for HIV, syphilis, hepatitis B or C with active infection
- History of bone marrow or organ transplantation
- Active uncontrolled infections within 2 weeks before treatment
- Irreversible electrolyte imbalances
- Neuromuscular diseases causing elevated creatine kinase
- Recent arterial or venous thrombotic events within 6 months
- Severe bleeding events within 4 weeks prior to treatment
- History of other cancers within 5 years except certain cured skin and cervical cancers
- Known allergy to study drugs or components
- Neurological or mental disorders such as epilepsy or dementia
- Central nervous system metastases
- Unresolved toxicities from prior anti-cancer treatments above grade 1
- Uncontrolled serious diseases including severe diabetes
- Live vaccine within 4 weeks before starting treatment or during the study
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Use of medications affecting certain liver enzymes that cannot be stopped
- Difficulty swallowing capsules or conditions preventing drug absorption
- Other conditions deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
D
Dongmei Ji, M.D
CONTACT
Y
Yu-Long Wang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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