Phase 1 clinical study to evaluate the safety and efficacy of MYJ1633 in patients with advanced or recurrent gastric cancer who failed 2nd standard therapy
- Conditions
- Not Applicable
- Registration Number
- KCT0006677
- 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 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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best overall response;Treatment Emergent Adverse Event
- Secondary Outcome Measures
Name Time Method Progression-Free Survival, PFS