None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Both mediators administer MYJ1633 5 times.
Mediation group 1 is administered every 1 week, mediation group 2 is administered once a day every 2 weeks,
Sponsors
Immunisbio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults over 19 years of age 2) Patients with at least one measurable lesion or assessable lesion in accordance with RECIST 1.1 and with histologically or cytologically confirmed gastric cancer 3) Gastric cancer patients with progressive or re-occurring lesions that show non-compliance with the first and second standard chemotherapy treatments (two or more combinations of chemotherapy failed) 4) A person with a life expectancy of more than 3 months. 5)ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 to 2 6) A person who voluntarily agrees in writing
Exclusion criteria
Exclusion criteria: 1) Troops (1) A person who has developed secondary cancer or has another cancer history within three years (2) A person transferred to the brain, central nervous system, etc. (3) A person who has received radiation and chemotherapy within one month for the treatment of this target disease (4) A person who has received CYtokine-Induced Killer (CIK) cell therapy power or other immunotherapy agents within 8 months (5) A person who is currently being treated for autoimmune disease or who has a history of treatment; (6) Patients with severe uncontrolled hypertension (7) A person with an active infectious disease (8) A person who is deemed unfit for clinical testing due to serious internal or psychiatric conditions in the medical opinion of the tester. 2) Anti-combination drugs and therapies (1) A person who has a long history of receiving a live vaccine within 4 weeks of the first administration date of IP or who needs to be administered a live vaccine during the clinical trial period. (2) A person who participated in another clinical trial within four weeks of the first administration date of IP and administered the medication for clinical trial 3) HIV, Syphilis, HBV, and HCV positive factors 4) A person who shows abnormalities through laboratory testing within 4 weeks of the first administration date of IP. (1) Neutrophil count =1.5 X10^9 /L (2) Platelets =100X10^9/L (3) Hemoglobin = 8.0g/dL (4) Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > ?????? ?????????? 2.5?? (5) Serum total bilirubin > 3.0 times the normal upper limit 5) overreaction (1) Patients with a history of severe hypersensitivity to MYJ1633 or the components of this clinical medicine 6) Pregnant women or lactating women 7) Contraception (1) A person who does not use medically acceptable contraceptives during the pre-clinical trial period; - Hormone therapy including oral contraceptives - Use of blocked contraceptives (for men or women) and pesticides at the same time - Vasectomy in your spouse (or partner) - Osteoarthritis and ligation, uterine extraction, in your own or spouse (or partner) - Using intrauterine devices with proven pregnancy failure rates in their own or spouse (or partner) (2) In the case of pregnant women, positive factors in the pregnancy response test 8) Other (1) A person who is medically judged and deemed inappropriate by doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best overall response;Treatment Emergent Adverse Event | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS | — |
Countries
Korea, Republic of
Contacts
Public Contactjieun yun
Immunisbio
Outcome results
None listed