Advanced solid tumor and lymphoma
Conditions
Interventions
Case series:Case series
Sponsors
307th Hospital of Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Cancer patients; 2. Aged 18~75years old male or female; 3. At least one measurable or evaluable lesion according to RECIST v1.1 (solid tumor) or Lugano 2014 criteria (lymphoma); 4. ECOG score= 1; 5. Female or male subjects of reproductive age and their mate are willing to take effective contraceptive measures for the entire treatment period and 6 months after the treatment; 6. With sufficient organ and bone marrow function; 7. At least 4 weeks after the last anti-tumor treatment before the first administration; 8. The patient or his legal representative signs a written informed consent.
Exclusion criteria
Exclusion criteria: 1. If you have experienced any NCI CTCAE v4.03 or greater than 3 grade irAE during previous immunotherapy treatment; 2. Has received any anti-PD-1 or anti-PD-L1 antibody treatment; 3. Subjects with other malignant tumors previously or concurrently; 4. Female patients with pregnancy or lactation; 5. Women/men who have fertility refusal to adopt contraception during the trial period; 6. Subjects with serious disease or complications, such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal failure, glaucoma, uncontrolled diabetes (CTCAE= 4.03: fasting blood glucose level = 2), and with active infection; 7. Had history of acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack 6 months before the screening ,grade 2 or above congestive heart failure devised by the New York Heart Association (NYHA); 8. Subjects with symptomatic brain metastases or mental disorders; 9. Subjects with abnormal levels of serum calcium, magnesium, potassium and have clinical significance; 10. Subjects with history of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation; 11. Subjects with active hepatitis B (HBsAg and/or HBcAb positive, and HBV DNA titer in peripheral blood was greater than 1 x 10^3 IU/ml), and/or hepatitis C; 12. Subjects who have alcohol addiction and/or drug abuse; 13. Subjects with bleeding or coagulation dysfunction in the past 3 months (PT>1.5×ULN; APTT>1.5×ULN; TT>1.5×ULN); 14. Subjects with allergic constitution or allergic to known components of the drug; 15. Those who received other clinical trial drug therapy within 1 month before the first administration; 16. Other subjects judged by the investigator to be ineligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD;Safety assesment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t, AUC0-8, AUCss, Tmax, t1/2, Vz, CL, MRT0-t, MRT0-8; AUC0-t, ss, AUC0-8, ss, Cav, CLss, MRT0-8, ss, Rac etc.;Immunogenic indicators;ORR, DOR, PFS; | — |
Countries
China
Contacts
Public ContactJianming Xu
307th Hospital of Chinese People's Liberation Army
Outcome results
None listed