Advanced solid tumorand Advanced Lymphomas
Conditions
Interventions
medication administration team:LBL-007
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Unlimited gender, aged >=18 years; 2. Patients with advanced solid tumors and advanced lymphomas diagnosed by histology or cytology if the standard treatment fails or lacks the standard treatment plan; 3. ECOG status score is 0 or 1 point; 4. The estimated survival time is at least 12 weeks; 5. Good organ function (no blood transfusion or blood products, no use of hematopoietic stimulating factors, no albumin or blood products transfusion within 14 days before the test): a. Platelet count >= 100 x 10^9 / L; absolute neutrophil count >= 1.5 x 10^9 / L; hemoglobin >= 90g / L; b. International standardized ratio (INR) = 60 ml /min; 6. Premenopausal women who have the possibility of childbirth must have a blood pregnancy test within 7 days before the first medication. The blood pregnancy test must be negative; it must be non-lactating; women with infertility can not undergo pregnancy tests and contraception, but One of the following two conditions must be met: (1) menopause for at least 12 months without the use of hormone therapy over the age of 50 years; (2) sterilization has been performed. All patients (male or female) should take adequate barrier contraception during the entire treatment period and 120 days after the end of treatment; 7. Subjects volunteered to participate in the study and signed informed consent, and voluntarily followed the trial treatment plan and visit plan.
Exclusion criteria
Exclusion criteria: 1. Have previously received any of the following treatments: a. Those who have received any other cytotoxic chemotherapy drugs within 4 weeks before the first application, such as nitrosourea and mitomycin C, should be more than 6 weeks from the last chemotherapy; b. Have received any targeted drugs or other anti-tumor drugs within 4 weeks before the first application; c. Have previously received antibody / drug treatment against LAG-3 immune checkpoints; d. Have received other antibodies / drugs against immune checkpoints, such as PD-1, PD-L1, CTLA-4, etc., within 4 weeks before the first medication; e. Those who have undergone major surgery and radiation therapy within 4 weeks before the first medication; f. Are using or have used NMPA-approved anti-tumor proprietary Chinese medicines and Chinese medicines with anti-tumor effects within 4 weeks before the first application; 2. Patients who participated in other interventional clinical trials within 4 weeks before enrollment; 3. Patients with severe active infection who need systemic systemic treatment within 1 week before enrollment; 4. Patients who have previously received an allogeneic bone marrow or organ transplant; 5. The patient has a known active or suspected autoimmune disease. Enroll patients who are in a stable state and do not require systemic immunosuppressive therapy; 6. Known or suspected central nervous system metastases; 7. Human immunodeficiency virus (HIV) infection; 8. Hepatitis B (HBsAg or HBcAb test is positive, and HBV-DNA test is positive. If the HBV-DNA test is positive, after receiving antiviral treatment, HBV-DNA drops to the normal range >= 2 weeks, you can enter the group, And must continue to receive antiviral therapy during the study period. For subjects who previously needed to receive or screen antiviral therapy, they must continue to receive antiviral therapy throughout the study period before they can be included in the study.), Hepatitis C (HCV Positive antibody test). Subjects with co-infection with hepatitis B and C (positive HBsAg or HBcAb test and positive HCV antibody test). 9. The following cardio-cerebral-vascular conditions: a. Clinically significant heart disease occurred within 6 months before enrollment, including congestive heart failure of greater severity than the New York Heart Association Grade II-IV, unstable angina (angina symptoms at rest), new onset of angina (3 months before enrollment) or myocardial infarction; b. Ventricular arrhythmias requiring antiarrhythmic drugs; QTc> 470ms (female) / 450ms (male); poorly controlled hypertension (systolic blood pressure> 150mmHg or diastolic blood pressure> 100mmHg); c. Thrombotic or embolic venous or arterial events, such as cerebrovascular accidents, including transient ischemic attack, stroke, arterial thrombosis, deep vein thrombosis, and pulmonary embolism within 6 months before enrollment; 10. Patients who do not control diabetes, severe lung disease or have evidence of bleeding constitution, coagulopathy, or are using warfarin, aspirin, low-molecular-weight heparin and other anti-platelet aggregation Chinese / Western medicine (except for small doses of prophylactic drugs); 11. Live or attenuated vaccine received within 4 weeks before administration; 12. Existence of Grade 2 and above toxicity (except for hair loss, CTCAE V5.0) due to previous antitumor treatment or surgery; 13. Subjects expected to receive systemic corticosteroids (or other immunosuppressive dr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| LBL-007 specific antibody ADA;Relationship between expression in tumor tissues and curative effect;Biomaker;Relationship between receptor occupancy rate and therapeutic effect;PK; | — |
Countries
China
Contacts
Public ContactYuankai Shi
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed