NCT04615312Unknown1 期
Phase I Clinical Study on the Safety and Tolerability of a CDK4 / 6 Inhibitor and a MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
研究概览
简要总结
This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years;
- •ECOG score ≤ 1;
- •Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed by histology or cytology and imaging diagnosis;
- •According to Recist1.1, there was at least one measurable lesion;
- •The expected survival time was more than 12 weeks;
排除标准
- •Patients who received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another intervention clinical trial;
- •Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors;
- •The third space effusion (such as massive pleural effusion or ascites) with clinical symptoms that cannot be controlled by drainage or other methods;
- •Allergy to any test drug and its excipients, or serious allergic history, or contraindication of the test drug;
- •Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
研究组 & 干预措施
a CDK4 / 6 inhibitor and a MEK inhibitor
Experimental
Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment
干预措施: a CDK4 / 6 inhibitor and a MEK inhibitor (Drug)
结局指标
主要结局
To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
时间窗: Up to approximately 24 months
次要结局
- ORR(Up to approximately 24 months)
研究者
LiNing
Chief Physician
Henan Cancer Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 in Combination With HLX10 in Patients With Advanced or Metastatic Solid TumorsSolid Tumor, AdultNCT05442996Shanghai Henlius Biotech30
进行中（未招募）
1 期
A Clinical Trial of CK0801 (a New Drug) in Patients With Bone Marrow Failure Syndrome (BMF)Bone Marrow DiseaseNCT03773393Cellenkos, Inc.18
进行中（未招募）
1 期
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid TumorsNCT05593094Hoffmann-La Roche210
招募中
1 期
CD70-targeted CAR-NKT Cells(CGC729) Therapy in the Renal Cell CarcinomaRenal Cell CarcinomaNCT06182735Fudan University9
已完成
1 期
Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural EffusionsMalignant Pleural EffusionsNCT03869697Clover Biopharmaceuticals AUS Pty Ltd5