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Clinical Trials/KCT0008025
KCT0008025Recruiting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 sites52 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Recruiting
Sponsor
Enrollment
52
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional Study

Eligibility Criteria

Ages
19(Year) to o Limit (—)
Sex
All

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
  • •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)

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
  • •? 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

Investigators

Sponsor
ational Cancer Center

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