None listed
Conditions
Interventions
Drug : -1b phase administration plan
-Dose level 1: CKD-702 15mg/kg IV Q2W (90 minutes infusion), Irinotecan 150mg/m2 IV Q2W
-Dose level 2: CKD-702 20mg/kg IV Q2W (90 minutes infusion), Irinotec
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 = 5x ULNs 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 patient 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)
Exclusion criteria
Exclusion criteria: 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 ? jaundice ? diarrhea ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Safety evaluation: Laboratory tests/evaluation of abnormal vital signs, adverse reactions, etc. in accordance with NCI CTCAE v5/Efficacy evaluation: Evaluation of tumor response is based on CT or MRI results of the abdomen and pelvis taken according to a set schedule Comprehensive and evaluated according to RECIST 1.1 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| For categorical variables, describe frequency and percentage, and for continuous variables, describe descriptive statistics as mean and standard deviation or median and quartiles (Q1, Q2) according to the assumptions of statistical theory (normality) | — |
Countries
Korea, Republic of
Contacts
Public ContactSu Yeon Kim
National Cancer Center
Outcome results
None listed