Assessment of Safety and Preliminary Clinical Efficacy with BAT6005 in Advanced Malignant Solid Tumors

Inclusion Criteria:

1. Age: ≥18 years old, gender: male or female;
2. The expected survival was assessed as at least 3 months;
3. ECOG (Eastern Oncology Collaboration group) physical status score requirement: 0 or 1;
4. Patients with locally advanced or metastatic malignant solid tumors confirmed by histology or cytology without standard therapy, failure of standard therapy, or inapplicable standard therapy;
5. According to RECIST 1.1, there must be evaluable tumor focus in dose increase stage, and at least one measurable tumor focus in dose expansion stage;
6. Fertile women must have a negative serum pregnancy test within 7 days prior to the first dose and be willing to use an effective method of birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dose.Male patients must agree to use an effective contraceptive method for the duration of the study until 6 months after the study's last dosing;Postmenopausal women must be amenorrhea for at least 12 months before they are considered infertile;

Exclusion Criteria:

1. Prior treatment with anti-TiGit monoclonal antibody or anti-TiGit active double antibody;
2. Had received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to the first use of the study drug
3. Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first use of the investigational drug;
4. Received live/attenuated vaccine and mRNA vaccine within 4 weeks prior to screening or plan to receive live/attenuated vaccine and mRNA vaccine during the study period;
5. Pregnant or lactating women;
6. Patients whose AE caused by previous anti-tumor therapy did not recover to CTCAE 5.0≤ 1;
7. Patients with cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms, judged by the investigator to be unsuitable for inclusion;
8. Patients who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or who required elective surgery during the study period;
9. Those with a history of tissue or organ transplantation;
10. Patients with active infection prior to the first administration and currently requiring intravenous anti-infection therapy;
11. Known history of human immunodeficiency virus (HIV) infection;
12. active hepatitis B;
13. Active HCV infected subjects
14. Subjects with untreated or undergoing treatment for tuberculosis, including but not limited to tuberculosis; Patients who have been prescribed anti-tuberculosis therapy and confirmed by the investigator to have been cured may be included;
15. The subject is known to have a history of severe allergy, or is known to have experienced grade ≥3 allergic reactions to macromolecular protein preparations/monoclonal antibodies in the past;
16. Patients who have active autoimmune diseases, or have had autoimmune diseases with recurrence risk (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except patients with clinically stable autoimmune thyroid diseases and type I diabetes;
17. Received systemic glucocorticoid (prednisone \> 10mg/ day or equivalent dose of the same drug) or other immunosuppressant treatment within 14 days prior to first use of the study drug; The exceptions are local, ocular, intraarticular, intranasal, and inhaled glucocorticoid therapy and short-term prophylaxis (e.g., to prevent contrast agent allergies).
18. IrAE ≥3 has been seen in the past;
19. existing interstitial lung disease;
20. Have a history of serious cardiovascular and cerebrovascular diseases;
21. Third interstitial effusion that could not be controlled clinically was judged not suitable for inclusion by the researcher;
22. Patients with a known history of psychotropic drug abuse or drug use that is considered to affect the compliance of this study;
23. Patients considered unsuitable for the study by the investigator.