Phase I Study of BC008-1A Injection in Patients With Advanced Solid Tumors

Exclusion Criteria

• •1. Having been previously exposed to any anti-TIGIT drugs.
• •2. Currently participating in another interventional clinical study, except for participation in observational (non-interventional) clinical studies or being in the survival follow-up stage of an interventional study.
• •3. Having received any investigational drugs within 4 weeks prior to the first administration of the study drug.
• •4. Having an autoimmune disease or a history of autoimmune diseases or related symptoms.
• •5. Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: systemic chemotherapy (the washout period for oral fluorouracil drugs is 2 weeks, and that for mitomycin C and nitrosourea drugs is 6 weeks), endocrine therapy, targeted therapy (the washout period for small molecule targeted therapy is 2 weeks or 5 half-lives, whichever is longer), immunotherapy, tumor embolization or treatment with traditional Chinese herbal medicines with anti-tumor indications, etc.
• •6. Having been treated with corticosteroid drugs or other immunosuppressive agents within 4 weeks before the first administration of the study drug.
• •7. Having received a live attenuated vaccine within 4 weeks before the first administration of the study drug or planning to receive it during the study period.
• •8. Having toxicity that has not recovered to grade 0 or 1 according to the NCI-CTCAE v5.0 caused by previous anti-tumor treatment within 4 weeks before the first dose of study treatment (excluding alopecia, fatigue or vitiligo), having unstable neuropathy or \> grade 2 neuropathy induced by previous anti-tumor treatment, including having unresolved immune-related adverse events (irAE) after receiving immunotherapy and those who have experienced irAE ≥ grade 3.
• •9. Having a history of pneumonia requiring steroid treatment, or having interstitial lung disease (including both past and present medical history).
• •10. Currently having an active infection (e.g., acute bacterial infection, tuberculosis, active hepatitis B/hepatitis C, pulmonary infection, etc.).
• •11. Known to have central nervous system (CNS) metastasis and/or spinal cord compression and/or carcinomatous meningitis, or having a history of leptomeningeal carcinoma.
• •12. Being positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and having HBV DNA higher than the upper limit of the normal value of the study center, or being judged by the doctor to have active hepatitis, being infected with hepatitis C virus (HCV), or being positive for human immunodeficiency virus (HIV) antibody, or being positive for Treponema pallidum antibody (Tp-Ab).
• •13. Having poorly controlled cardiac clinical symptoms or diseases, such as uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), unstable angina pectoris or having had a myocardial infarction within 6 months before enrollment in the trial, or having poorly controlled arrhythmia (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women, with the QTc interval calculated by the Fridericia formula), etc.
• •14. Having a cardiac function classification (NYHA) of grade III or IV, and having a left ventricular ejection fraction (LVEF) \< 50% at rest.
• •15. Having suffered from other malignant tumors within five years (except for completely cured or curable cancers, such as basal cell skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, or any type of carcinoma in situ that has been completely resected, such as carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, etc.).
• •16. Being allergic to the components or excipients of the experimental drug, antibody drugs or any other therapeutic proteins (such as fresh frozen plasma, human serum albumin, cytokines or interleukins, etc.), or having a severe allergy history, or being suspected of having a severe allergic reaction (NCI-CTCAE v5.0 ≥ grade 3).
• •17. Having a history of alcoholism, drug addiction or drug abuse within 1 year before screening.
• •18. Having a clear history of neurological or psychiatric disorders in the past, such as epilepsy, dementia, or being poorly compliant.
• •19. Pregnant or lactating women.
• •20. Other circumstances that the investigator deems unsuitable for participation in this study.