clinical study to evaluate the safety and efficacy of MYJ1633 in patients with gastrointestinal cancer with confirmed peritoneal metastasis who failed 2nd standard therapy
- Conditions
- Neoplasms
- Registration Number
- KCT0008443
- Lead Sponsor
- Immunisbio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1) adults over 19 years of age
2) Patients with histologically or cytologically confirmed gastrointestinal cancer (gastric cancer or colorectal cancer) with at least one measurable or assessable lesion according to RECIST 1.1
3) Patients with gastrointestinal cancer (gastrointestinal cancer or colon cancer) who do not comply with or have resistance to secondary standard chemotherapy and are unable to use known standard therapy
4) Peritoneal metastasis confirmed by CT or laparoscope
5) A person who has a life expectancy of 3 months or more
6) Patients with an Eastern Cooperative Oncology Group performance status (ECOGPS) of 0 to 2
7) a person who voluntarily agrees in writing
1) medical history
(1) a person who has spread to the brain, central nervous system, etc
(2) A person who has received radiation or chemotherapy within two weeks for the treatment of this disease
(3) A person who has received CIK (Cytokine-Induced Killer) cell therapy or other cell therapy within one month
(4) Those currently being treated for autoimmune diseases or those with past treatment history (Patients with past treatment history can participate at the discretion of the person in charge if there are no abnormalities in the screening test results)
(5) a patient with uncontrolled and severe hypertension
(6) A person who is deemed unfit for clinical trials due to a serious medical or psychiatric disease in the medical opinion of the tester
2) Those who have a history of receiving live vaccines within 4 weeks of the screening visit or who need to administer live vaccines during the clinical trial period
3) A person who has participated in another clinical trial and administered a clinical trial drug within 4 weeks of a screening visit
4) HIV, Syphilis, HBV, HCV positive
5) A person who shows abnormalities through laboratory tests within 4 weeks based on baseline
6) MYJ1633 or patients with a history of severe hypersensitivity to components of this clinical trial drug
7) a pregnant or lactating woman
8) Those who do not use medically acceptable contraception during the pre-clinical trial period
9) A person deemed inappropriate by the tester medically
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method