NCT07446270
尚未招募
2 期
A Cohort Clinical Study to Evaluate the Efficacy and Safety of Tunlametinib Combined With Anti-EGFR Monoclonal Antibody in Patients With RAS-mutated Advanced Gastrointestinal Malignancies
Chinese PLA General Hospital0 个研究点目标入组 90 人开始时间: 2026年3月3日最近更新:
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Chinese PLA General Hospital
- 入组人数
- 90
- 主要终点
- ORR
概览
简要总结
Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing of written informed consent prior to enrolment;
- •Age \> 18 years, males and females eligible;
- •Patients with histologically or pathologically confirmed advanced pancreatic cancer or advanced colorectal cancer who have failed standard therapy;
- •Genetic testing demonstrating RAS mutation;
- •At least one measurable lesion according to RECIST v1.1 assessment;
- •ECOG performance status: 0-1;
- •Expected survival ≥ 3 months;
- •Major organ function meets the following requirements:
- •Haemogram: Neutrophils ≥ 1.5 × 10⁹/L; Platelet count ≥ 90 × 10⁹/L; Haemoglobin ≥ 80 g/L; These haematological parameters must be maintained without the need for G-CSF, platelet or TPO transfusions, blood transfusions, or erythropoietin support therapy 14 days prior to the first dose.
- •Hepatic and renal function: Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 5 times ULN; Urine protein \<2+; if urine protein ≥2+, 24-hour urine protein quantification must show protein ≤1g;
排除标准
- •Known contraindications affecting the investigator's choice of therapeutic drug (as per the latest drug information leaflet)
- •Receipt of any other investigational treatment within 4 weeks prior to study dosing initiation;
- •Major surgery (excluding biopsies or minor outpatient procedures such as vascular access placement) or severe trauma within 4 weeks prior to first dosing, or planned major surgery within 30 days after first dosing (as determined by the investigator);
- •Presence of clinically symptomatic third-space effusions (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;
- •Symptomatic or untreated brain metastases, meningeal metastases, or spinal cord compression, except for: Asymptomatic brain metastases (i.e., no progressive CNS symptoms attributable to brain lesions, no requirement for corticosteroids or antiepileptic drugs, and imaging confirmation of stable disease for ≥4 weeks); Patients undergoing stereotactic brain radiotherapy or surgery may be eligible if no disease progression is observed in the brain over a period of ≥3 months;
- •Cardiac impairment or clinically significant cardiovascular disease with uncontrolled cardiac symptoms or conditions, such as: (1) NYHA Class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- •History or presence at screening of retinal disease, including: retinal vein occlusion (RVO), retinal artery occlusion, retinal vasculitis, diabetic retinopathy, hypertensive retinopathy, retinal capillaropathy (Costs disease), retinal pigment epithelial detachment (RPED), etc.; Screening for risk factors of RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulable syndromes); retinal diseases such as RPED;
- •Interstitial lung disease or interstitial pneumonia, including patients with clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring intervention);
- •Known active tuberculosis (TB); subjects suspected of active TB requiring clinical investigation to rule out; known active syphilis infection;
- •Human immunodeficiency virus (HIV) antibody positive, syphilis antibody (Anti-TP) positive, hepatitis C virus (HCV) antibody positive with HCV RNA positive, hepatitis B virus surface antigen (HBsAg) positive with HBV DNA positive (HBsAg positive requires further testing for HBV DNA, HBV DNA ≥ 200 IU/ml, or ≥ 10³ copies/ml);
研究组 & 干预措施
Colorectal cancer: Tunlametinib + cetuximab β
Experimental
干预措施: Colorectal cancer: Tunlametinib + cetuximab β (Drug)
Pancreatic cancer: Tunlametinib + cetuximab β
Experimental
干预措施: Pancreatic cancer: Tunlametinib + cetuximab β (Drug)
Pancreatic cancer: Tunlametinib + Nimotuzumab
Experimental
干预措施: Pancreatic cancer: Tunlametinib +Nimotuzumab (Drug)
结局指标
主要结局
ORR
时间窗: 2 years
次要结局
- DOR(2 years)
- OS(2 years)
- AEs(2 years)
- PFS(2 years)
- DCR(2 years)
研究者
Dai, Guanghai
Professor
Chinese PLA General Hospital
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