BAT7104 Injection in Patients With Advanced Malignant Tumors.

Inclusion Criteria:

1. Age: ≥ 18 years old and ≤ 80 years old, gender: male or female;

2. The investigator evaluated the expected survival period to be at least 3 months;

3. The requirement of the ECOG physical fitness score is 0 or 1;

4. Patients with advanced malignant tumors who have failed to receive standardtreatment, have no standard treatment, do not tolerate standard treatment or refuseto accept standard treatment confirmed by cytology or pathology;

5. There must be an evaluable tumor focus in the dose increasing stage, and at leastone measurable tumor focus in the dose expanding stage (solid tumors refer to RECIST 1.1 standard, lymphoma refer to Lugano 2014 evaluation standard);

6. It has sufficient organ and bone marrow reserve function, which is defined asfollows: System laboratory reference value: Blood routine (no blood transfusion, no use of hematopoietic stimulating factor andno use of drugs to correct blood cell count within 14 days before the firstadministration): Absolute neutrophil count ≥ 1.5 x 109/L;Platelet count ≥ 90 x109/L;Hemoglobin ≥ 90g/L; Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5xULN (without anticoagulant treatment), those who receive oralanticoagulant treatment and whose INR is 2~3 can be included. Liver function: Total bilirubin (TBIL) ≤ 1.5xULN;Hepatocellular carcinoma, Gilbert's syndrome, livermetastasis ≤ 2xULN;Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5xULN;Hepatocellular carcinoma, liver metastasis ≤ 5xULN renal function Serumcreatinine or Serum creatinine clearance ≤ 1.5xULN or>50ml/min (usingCockcroft-Gault formula, see appendix)

7. Agree to provide archived pathological tissue or fresh biopsy tumor tissue for thedetection of PD-L1, CD47 expression level or receptor occupancy and otherpharmacodynamic indicators (not as a necessary inclusion standard); Female patientswith fertility must have negative serum pregnancy test within 7 days before thefirst administration and are willing to take effective birth control/contraceptionmethods to prevent pregnancy during the study period until 6 months after the lastadministration of the study. Male patients must agree to take effectivecontraceptive methods during the study period and within 6 months after the lastadministration of the study; Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.

Exclusion Criteria:

1. Have received any anti-CD47 antibody and SIRP within 4 weeks before the firstadministration α Antibodies or CD47/SIRP α Recombinant protein therapy;

2. He has received chemotherapy, radiotherapy, biological therapy, endocrine therapy,immunotherapy and other anti-tumor treatment within 4 weeks before the first use ofthe study drug, with the exception of the following: ① nitrosourea or mitomycin Cwithin 6 weeks before the first use of the study drug; ② Oral fluorouracil andsmall-molecule targeted drugs are 2 weeks before the first use of the study drug orwithin 5 half-lives of the drug (whichever is longer); ③ The systematic treatment oftraditional Chinese medicine/proprietary Chinese medicine with clear anti-tumoreffect and drugs with immunomodulatory effect (including but not limited tothymosin, interferon, interleukin, etc.) is within 2 weeks before the first use ofthe study drug;

3. Those who are participating in or have participated in the experimental drug ormedical device intervention clinical research within 4 weeks before the firstadministration of this study cannot be included; In the survival follow-up stage ofthe intervention study, if the time between the first administration and the end ofthe previous study (the last administration) meets the above exclusion criteria, itcan be included;

4. Inoculated or planned to receive live/attenuated vaccine and mRNA vaccine within 4weeks before screening;

5. Pregnant or lactating women;

6. AEs caused by previous anti-tumor therapy are still higher than grade 1 (based onCTCAE v5.0) before the first administration of the study drug (except for AEs suchas hair loss and fatigue that cannot be restored to ≤ grade 1 and will remain stablefor a long time according to the judgment of the researcher based on clinical actualconditions, except for grade 2 peripheral neurotoxicity, and hypothyroidismstabilized by hormone replacement therapy);

7. Those who have had ≥ 3 levels of irAE in the past or have terminated immunotherapydue to any level of irAE;

8. Primary central nervous system tumor, central nervous system metastasis with relatedsymptoms, meningeal metastasis or previous history of epilepsy should be excluded.Patients with asymptomatic or asymptomatic central nervous system metastasis whohave been clinically controlled but have been judged stable by the researcher can beincluded, but the following conditions must be met at the same time: a The diseasewas stable ≥ 4 weeks before the first administration; B. No evidence of centralnervous system disease progression was found in MRI enhancement of the head within 4weeks before the first administration; C. The anticonvulsant drugs have been stoppedat least 2 weeks before the first administration, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of hormone;

9. Patients who have undergone major organ surgery (excluding puncture biopsy) or hadsignificant trauma within 4 weeks before the first use of the study drug, or whoneed to undergo elective surgery during the trial period;

10. Have a history of tissue or organ transplantation;

11. Patients with severe infection within 4 weeks before the first medication, includingbut not limited to infection complications, bacteremia, severe pneumonia, etc.requiring hospitalization; Patients with active infection before the firstadministration were excluded;

12. Known history of human immunodeficiency virus (HIV) infection;

13. Active hepatitis B, untreated chronic hepatitis B or treated but uncontrolledchronic hepatitis B (HBV DNA>200 IU/mL or>103 copies/ml);

14. Active HCV infected patients (HCV antibody positive and HCV-RNA level higher thanthe lower limit of detection);

15. Untreated or under treatment tuberculosis patients, including but not limited totuberculosis; Those who have received standard anti-tuberculosis treatment and havebeen confirmed as cured by researchers can be included;

16. Known to have a history of severe allergy, or known to have had ≥ grade 3 allergicreaction to macromolecular protein preparation/monoclonal antibody, and anycomponent of test drug;

17. Patients with active, or had a history of autoimmune diseases that may recur (excluding vitiligo, autoimmune thyroid diseases that can be treated with hormonereplacement therapy, and type 1 diabetes patients);

18. Have received systemic glucocorticoid (prednisone>10mg/day or equivalent dose of thesame drug) or other immunosuppressive treatment within 14 days before the first useof the study drug, except for the following cases: ① use of local, ocular,intraarticular, intranasal and inhaled glucocorticoid treatment, ② short-term use ofglucocorticoid for preventive treatment (such as prevention of contrast agentallergy);

19. Patients who have a history of non-infectious pneumonia requiring glucocorticoidtreatment or who currently have interstitial lung disease within 1 year before thefirst administration;

20. There is a history of serious cardio-cerebrovascular disease, including but notlimited to: ① heart failure or left ventricular ejection fraction (LVEF)<50% withNYHA grade II or above; ② There are serious cardiac rhythm or conductionabnormalities, such as ventricular arrhythmia requiring clinical intervention, Ⅱ - Ⅲdegree atrioventricular block, etc.; ③ Acute coronary syndrome, congestive heartfailure, aortic dissection, stroke or other cardiovascular and cerebrovascularevents of grade 3 or above occurred within 6 months before the first administration; ④ Hypertension that cannot be controlled clinically (this protocol is defined asthat although antihypertensive treatment is adopted, the systolic blood pressure ismore than 150 mmHg and/or diastolic blood pressure is more than 100 mmHg aftertreatment, and has clinical significance after evaluation by the researcher);

21. Those with the following risk of thrombosis or bleeding: A. Myocardial infarction, unstable angina pectoris, cerebrovascular accident ortransient ischemic attack occurred within 6 months before the first administration;B. There is a history of deep venous thrombosis, pulmonary embolism or any otherserious thromboembolism within 3 months before the first administration (implantablevenous infusion port or catheter-derived thrombosis, or superficial venousthrombosis is not considered as "serious" thromboembolism); C. Any life-threateningbleeding event or grade 3 or 4 gastrointestinal/variceal bleeding event requiringblood transfusion, endoscopy or surgical treatment within 3 months before the firstadministration; D. Other diseases that the researcher believes have a high risk ofbleeding or thrombosis in the future;

22. Patients who are known to have a history of abuse or drug abuse of psychotropicsubstances and are considered to affect the compliance of this study;

23. Have a history of hemolytic anemia or Evans syndrome in the past 3 months;

24. In addition to the tumors at the time of study, there are other active malignanttumors within 3 years before the first administration (not excluding locally curedtumors, such as skin basal cell carcinoma, superficial bladder cancer cancer orbreast cancer in situ);

25. Patients with pleural effusion, pericardial effusion or ascites that are notcontrolled or need drainage;

26. Patients who are not suitable for this study according to the researcher.