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New treatment option for Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS...
Official title Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer
ClinicalTrials.gov ID: NCT06970353
What this study is testing
What is Tunlametinib?
Tunlametinib is an investigational medicine, being studied as a potential treatment for radioactive iodine-refractory, differentiated thyroid cancer with nras mutation.
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
- 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.
- 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
- 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...
- Iodine refractory thyroid cancer;
- Differentiated thyroid cancer not suitable for iodine therapy;
You likely can't join if
- Within 4 weeks before the first medication, major surgery (excluding biopsy and outpatient minor surgery, such as placement of vascular access) or...
- There are clinical symptoms of third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount...
- Cardiovascular and cerebrovascular diseases with impaired heart function or significant clinical significance, including but not limited to any of...
- Symptomatic congestive heart failure (NYHA classification ≥ II); Evidence of clinically significant arrhythmia and/or conduction abnormalities within...
- Poor control of hypertension (systolic blood pressure ≥ 140 and/or diastolic blood pressure ≥ 90 mmHg under medication control); Abnormal cardiac...
- History of congenital long QT syndrome; Or those who take drugs known to prolong the QT interval and cannot guarantee discontinuation during the...
See the full eligibility criteria
Who can join
- 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.
- ECOG score 0-2 points; According to RECIST v1.1 evaluation, there is at least one assessable lesion; 7\. Expected survival\>12 weeks; 8. The main organ function and bone marrow function are normal.
- Blood routine: Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); Absolute neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L;
- Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) are ≤ 2.5 times the upper limit of normal (ULN). If there is liver metastasis, ALT and AST are ≤ 5 times...
- Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate calculated by Cockroft Gault formula\>60 mL/min;
- Cardiac function: Echocardiography shows a left ventricular ejection fraction (LVEF) of ≥ 55%; ECG QTcF ≤ 480ms; Creatine kinase (CK) ≤ 1 × ULN, troponin/hypersensitive troponin ≤ 1 × ULN;
- Coagulation function: International normalized ratio of prothrombin time (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 9. Women of childbearing age must undergo a pregnancy test (serum or...
What rules you out
- 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: Within 6 months prior to the start of treatment, acute...
- Symptomatic congestive heart failure (NYHA classification ≥ II); Evidence of clinically significant arrhythmia and/or conduction abnormalities within 6 months prior to the start of treatment or at present;
- Poor control of hypertension (systolic blood pressure ≥ 140 and/or diastolic blood pressure ≥ 90 mmHg under medication control); Abnormal cardiac valve morphology (≥ grade 2) recorded by echocardiography, Note: Patients...
- History of congenital long QT syndrome; Or those who take drugs known to prolong the QT interval and cannot guarantee discontinuation during the study period;
- 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...
- 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...
- 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...
- Irreversible electrolyte abnormalities (hypokalemia, hypomagnesemia, hypocalcemia detected by blood biochemistry);
- Neuromuscular diseases related to CK elevation in the past or present (such as inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome);
- Arterial/venous thrombotic events that occur within 6 months prior to the first use of medication, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep...
- Within 4 weeks prior to the first use of medication, the occurrence of Grade 3 bleeding symptoms as defined in the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0);
- Patients with a history of other malignant tumors within the past 5 years, except for those who have been completely cured of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and cervical carcinoma...
- Individuals who are known to be allergic to any component of the investigational drug;
- Have a clear history of neurological or mental disorders, including epilepsy and dementia;
- Central nervous system (CNS) metastasis;
- Prior to drug administration, all relevant anti-tumor treatment toxicity reactions (excluding hair loss, skin pigmentation, grade 1 chemotherapy related peripheral neurotoxicity, grade 2 toxicity caused by immune...
- Uncontrolled concomitant diseases, including but not limited to severe diabetes (fasting blood glucose\>250 mg/dl or 13.9 mmol/L), or other serious diseases requiring systemic treatment;
- Vaccination with live or attenuated vaccine within 4 weeks prior to the first dose (note: if enrolled, people must not receive live vaccine during the study treatment period and within 30 days after the last dose of the...
- For premenopausal female people (postmenopausal female patients must have been menopausal for at least 12 months to be considered infertile), the pregnancy test result is positive; During the study period and at least...
- Patients who are known to be allergic to the components of the investigational drug or its analogues;
- Patients who are receiving intravenous or oral medications that affect CYP isoenzymes (strong inducers and inhibitors of CYP2C9 and CYP3A4) and cannot discontinue the protocol at least one week before starting study...
- Inability to swallow capsules or intractable nausea and vomiting, malabsorption, extracorporeal bile diversion, or any significant small bowel resection that may hinder the full absorption of the study drug;
- Other situations that researchers consider unsuitable for inclusion. If accompanied by family or social factors, it may affect the safety of the people or the collection of data and samples.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai 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 Shanghai, Shanghai 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.