Solid Tumors
Conditions
Interventions
Group 1:BAT1308 Injection 100mg
Group 2:BAT1308 Injection 300mg
Group 3:BAT1308 Injection 600mg
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged from 18 to 75 (including boundary value) years, regardless of gender; 2. Patients who voluntarily sign informed consent; 3. Study population: Patients with advanced solid tumor confirmed by pathology, failed standard treatment or intolerable standard treatment; 4. According to the recist1.1 standard, patients with at least one measurable tumor focus; 5. Patients with ECoG score of 0 or 1; 6. The researchers evaluated patients with expected survival >= 12 weeks; 7. Patients with sufficient organ and bone marrow functions; 8. Female patients with fertility must have negative serum pregnancy test within 7 days before the first administration and are willing to take effective birth control / contraception methods to prevent pregnancy during the study period until 6 months after the last administration of the study. Male patients must agree to use effective contraceptive methods during the study until 6 months after the last administration of the study.
Exclusion criteria
Exclusion criteria: 1. Patients who are participating in or have participated in the clinical study of experimental drugs or medical devices within 4 weeks before the first administration of this study; 2. Patients with ae not recovered to ctcae5.0 150mmhg and / or diastolic blood pressure > 100mmhg after treatment); 6. Patients with a history of autoimmune diseases; 7. There are patients with active infection of clinical significance who need systemic treatment, including tuberculosis; 8. Patients with the following diseases: human immunodeficiency virus (HIV) infection; Treponema pallidum antibody positive; hepatitis B virus infected patients [if any of HBsAg or HBcAb is positive, the detection of HBV DNA is more than 2000 IU / ml (or 1 * 10^4 copies / ml)]; hepatitis C virus infected patients (HCV antibody and RNA were positive); 9. The patients who had been vaccinated or planned to receive live / attenuated vaccine in the first 4 weeks were screened; 10. Patients known to have severe hypersensitivity to any monoclonal antibody; 11. Patients who have known a history of psychoactive drug abuse or abuse and are considered to affect the compliance of this study; 12. Pregnant or lactating women; 13. Other patients who were not suitable for the study were considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance and Security; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;PD-1 Receptor Occupancy;Immunogenicity;Effectiveness evaluation; | — |
Countries
China
Contacts
Public ContactSuxia Luo
He'nan Cancer Hospital
Outcome results
None listed