Phase 1b/2 trial for CKD-702 in combination with irinotecan as a third-line therapy for gastric cancer with MET or EGFR protein overexpressio

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0008025
• Lead Sponsor: ational Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 52

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-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 Outcome Measures

Name	Time	Method
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)