Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer (NCT06970353) | Clinical Trial Compass
RecruitingPhase 2
Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer
China40 participantsStarted 2025-05-27
Plain-language summary
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)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients voluntarily join this study and sign an informed consent form;
✓. Age: ≥ 18 years old, male or female not limited;
✓. For locally advanced or recurrent/metastatic thyroid cancer diagnosed by histology and unable to undergo curative surgery, one of the following requirements must be met:
✓. Iodine refractory thyroid cancer;
✓. Differentiated thyroid cancer not suitable for iodine therapy;
✓. High grade, poorly differentiated or poorly differentiated thyroid cancer;
✓. Undifferentiated thyroid carcinoma;
✓. Have undergone NGS testing (at our hospital or an external hospital), and be able to find that the test report or medical history has recorded a positive result for NRAS mutation in the gene test.
Exclusion criteria
✕. Within 4 weeks before the first medication, major surgery (excluding biopsy and outpatient minor surgery, such as placement of vascular access) or severe trauma occurred;
✕. There are clinical symptoms of third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of pleural fluid or ascites);
✕. Cardiovascular and cerebrovascular diseases with impaired heart function or significant clinical significance, including but not limited to any of the following:
✕. Previous or screening retinal diseases, such as retinal vein occlusion (RVO), retinal artery occlusion, retinal vasculitis, diabetes retinopathy, hypertensive retinopathy, retinal telangiectasia (Costs disease), retinal pigment epithelial detachment (RPED), etc; Risk factors for RVO during screening (such as uncontrolled glaucoma or high intraocular pressure, history of high viscosity or hypercoagulability syndrome); Retinal diseases such as RPED;
✕. Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonitis (i.e. affecting daily living activities or requiring intervention treatment);
✕. Positive for human immunodeficiency virus (HIV) antibodies, syphilis antibodies (Anti TP), hepatitis C virus (HCV) antibodies and HCV RNA, hepatitis B virus surface antigen (HBsAg) and HBV DNA (HBsAg positivity requires further testing for HBV DNA, HBV DNA ≥ 200 IU/ml, or ≥ 103 copies/ml);
✕. History of allogeneic bone marrow transplantation or organ transplantation;
✕. There are uncontrollable active infectious diseases (such as intravenous drip of antibiotics, antifungal or antiviral drugs) within 2 weeks before the first administration, or fever of unknown cause\>38.5 ° C occurs during screening/before the first administration;