NCT06980532招募中1 期
Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer: A Prospective, Exploratory, Open-Label Clinical Study
Liu Huang1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年4月25日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Recommended dose for Phase II
研究概览
简要总结
Glumetinib combined withFruquintinib in the treatment of MET amplification or protein overexpression in third-line unresectable metastatic colorectal cancer: evaluation of efficacy and safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients fully understood this study, voluntarily participated and signed the Informed Consent Form (ICF);
- •Age ≥18 years old;
- •Patients with unresectable metastatic colorectal cancer with microsatellite stable (MSS) confirmed by pathology or histology;
- •Have MET amplification (FISH MET GCN≥4 or MET/CEP7≥1.8; Or NGS, ≥20% of tumor cells, ≥200X sequencing depth, GCN≥4) or overexpression (IHC, 3+(≥50% of tumor cells are strongly positive) or 2+ (≥50% of tumor cells are moderately positive/strongly positive and < 50% of tumor cells are strongly positive); Immunohistochemistry (IHC) detection showed that the MET protein overexpression in the subjects was 3+(strongly positive in ≥50% of tumor cells) or 2+ (positive in ≥50% of tumor cells/weakly positive and strongly positive in < 50% of tumor cells).
- •Imaging confirmed progression after previous two-line standard anti-tumor regimens;
- •According to RECIST1.1 criteria, the patient has at least one measurable target lesion; For lesions that have undergone radiotherapy in the past, they can only be included in measurable lesions when there is clear disease progression after radiotherapy.
- •Eastern Cooperative Oncology Group (ECOG) Physical Status Score: 0-1 point;
- •The expected survival time is ≥3 months;
- •Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥75×10^9/L and hemoglobin 80 g/L, white blood cell count (WBC) ≥3.0×10^9/L (corrected by no blood transfusion, no blood products, no use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor within 14 days before laboratory tests);
- •Liver and kidney functions: Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50mL/min; AST and ALT ≤2.5 times the upper limit of normal values (for patients with liver invasion, ≤5 times the upper limit of normal values); Serum total bilirubin ≤2 times the upper limit of normal value (for patients with liver invasion ≤2.5 times the upper limit of normal value);
- •The activated partial thromboplastin time (APTT), International normalized ratio (INR), and prothrombin time (PT) are ≤1.5 times the normal upper limit value.
- •Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods (such as intrauterine devices [IUD], contraceptives or condoms) during the test and 6 months after the last administration of the test drug; The serum pregnancy test must be negative within 7 days before enrollment in the study, and the subjects must be non-lactating. Male subjects who should agree that contraceptive measures must be adopted during the study period and within 6 months after the end of the study period;
排除标准
- •Have received MET inhibitor treatment in the past;
- •Patients with unresectable metastatic colorectal cancer who have MSI-H/dMMR (MSI detection shows instability at two or more sites, and MMR detection shows loss of expression at any one protein);
- •Patients with unresectable metastatic colorectal cancer whose BRAF gene test is mutant and who have not received BRAF inhibitors /MEK inhibitors;
- •Patients with severe active bleeding, active peptic ulcers, unhealed gastrointestinal perforations, and peptic fistulas;
- •Have hypersensitivity reactions to any investigational drug or its components;
- •Concurrent severe and uncontrolled concurrent infections or other severe and uncontrolled concomitant diseases, moderate or severe renal injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.)
- •Infection during the active stage of hepatitis B and C (positive hepatitis B virus surface antigen and hepatitis B virus DNA exceeding 1 × 103 copies /mL; Hepatitis C virus RNA exceeds 1 × 103 copies /mL;
- •Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- •Have had or are currently suffering from other malignant tumors simultaneously (except for effectively controlled non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years);
- •Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- •Those with other malignant tumors requiring treatment;
- •The researchers judged that patients were not suitable to participate in this study.
研究组 & 干预措施
Glumetinib combined with Fruquintinib
Experimental
干预措施: Glumetinib Combined with Fruquintinib (Drug)
结局指标
主要结局
Recommended dose for Phase II
时间窗: Up to approximately 18 Weeks
The dose determined during dose-escalation trials for use in Phase II studies, typically based on safety and tolerability data.
Objective response rate(ORR)
时间窗: Up to approximately 18 Weeks
In the phase II study,CR + PR rate according to the RECIST version 1.1 guidelines.
次要结局
- Maximum tolerated dose(MTD)(Up to approximately 18 Weeks)
- Dose-limiting toxicity（DLT）(Up to approximately 18 Weeks)
- Assess Adverse Events(up to 12 months)
- Disease control rate（DCR）(Up to approximately 18 Weeks)
- Overall Survival (OS)(Up to approximately 36 Months)
- Objective Response Rate (ORR)(Up to approximately 18 Weeks)
- Progression-free survival（PFS）(Up to approximately 18 Weeks)
研究者
Liu Huang
Professor
Tongji Hospital
研究点 (1)
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