KCT0008025招募中未知
Phase 1b/2 trial for CKD-702 in combination with irinotecan as a third-line therapy for gastric cancer with MET or EGFR protein overexpression
ational Cancer Center0 个研究点目标入组 52 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Pathologically or cytologically confirmed gastric adenocarcinoma
- •2. Be at least 19 years of age on the date you sign the consent form
- •3. Patients with ECOG performance status 0-1
- •4. Patients with expected survival > 12 weeks.
- •5. Persons with confirmed adequate organ function, as defined in the applicable section below;
- •1) Absolute neutrophil count (ANC) = 1.5 x 109
- •/L (= 1,500 per mm3
- •2) Platelet count = 100 x 109
- •/L (= 100,000 per mm3
- •3) Serum bilirubin = 1.5 x institutional upper limit of normal (ULN).
- •(Gilbert's syndrome is an exception).
- •4) AST (SGOT)/ALT (SGPT) = 2.5 x institutional UNL: with liver metastasis
- •5) 24-h urine creatinine clearance or eGFR > 40 mL/min
- •6. For women, negative pregnancy test or non-fertile women defined as:
- •1) Menopause (absence of menstruation for more than 1 year without other medical reasons)
- •2) Hysterectomy or bilateral tubal ligation or bilateral oophorectomy has been performed
- •7. Previous administration of targeted therapy for EGFR or targeted therapy for MET
- •Subjects with EGFR/MET bispecific antibody may be enrolled, but
- •Subject cannot be enrolled
- •8. Proteomic screening test (triple quadrupole multiple reaction mass spectrometry)
- •monitoring (MRM); Domestic application number, 10-2020-0187190) result EGFR or MET
- •Overexpression of (but not applicable for group 1b)
- •-However, global proteomic profiling (Appendix 2)
- •Even with overexpression of EGFR/MET peptide, which was proven by mass spectrometry, in phase 2 clinical trials
- •It is possible to register, and it is impossible to conduct a proteomic screening test, or the subject
- •In case of disagreement, central laboratory administration EGFR as described in Appendix 3
- •Alternatively, a positive MET immunohistochemical staining result can be enrolled in a phase 2 clinical trial.
- •9. Presence of a measurable lesion on RECIST (but not applicable for Group 1b.)
- •10. Progression of disease after administration of two or more anticancer drugs for the treatment of metastatic gastric cancer
- •(progressive disease) (administration of anticancer drugs used as adjuvant chemotherapy)
- •Progression of disease within 6 months of interim or end (based on the date of the last anticancer drug administration)
- •In this case, the disease is considered to have progressed with the administration of one anticancer drug)
排除标准
- •1. Based on the first day of administration of this clinical study drug (Cycle 1 Day 1), systemic anticancer treatment (
- •The last day of administration of immunotherapy, small molecule target therapy) is 14 days
- •less than 28 days, or the last dose of monoclonal antibody was less than 28 days;
- •The last dose of nitrosourea/mitomycin C was less than 42 days (if the period
- •Even if it has not elapsed, it is possible to obtain informed consent and carry out screening tests)
- •2. History of primary cancer other than gastric cancer
- •However, exceptions are recognized in the following cases:
- •1) Curative treatment of cancer, disease-free for more than 3 years and recurrence
- •low risk patients
- •2) Present as cured skin cancer (non-melanoma skin cancer, lentigo maligna)
- •Patients with no disease
- •3) Cured in situ carcinoma, currently disease-free patient
- •3. It is difficult to evaluate the clinical trial results in the judgment of the researcher regarding the subjects
- •lower condition, treatment or history judged to be
- •4. Uncontrolled active infection, symptomatic heart failure, uncontrolled hypertension/
- •Unstable angina/arrhythmia, active bleeding tendency, active hepatitis, impaired written consent
- •Mental illness or social conditions that cause
- •5. Patients with a history of leptomeningeal metastasis.
- •6. Patients with uncontrolled brain metastases or spinal nerve compression (administration of clinical trial drugs)
- •Patients with stable symptoms who have stopped taking anticonvulsants at least 14 days ago can be enrolled)
- •7. Uncontrolled seizures (seizure)
- •8. Pregnant or possibly pregnant and lactating women, end of clinical trial
- •Men who are not willing to use adequate contraception until after 180 days; or
- •women of childbearing potential
- •9. Severe and/or uncontrolled medical conditions
- •? intestinal paralysis
- •? intestinal obstruction
- •? Severe infection
- •? Massive ascites, pleural fluid
- •10. If there is interstitial lung disease, history of pulmonary fibrosis, or radiographic evidence
- •11. Patients who absolutely need strong CYP3A4 inhibitors
- •:Typically Atazanavir Sulfate
- •12. Patients with a history of hypersensitivity to irinotecan
- •13. Dialysis patients
- •14. Patients taking St. John's Wort
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