A Clinical Study of YL205 in Patients With Advanced Solid Tumors

Exclusion Criteria18

• \) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.
• \) Subjects who are participating in another clinical study, with the exception an of observational (non-interventional) clinical study or the follow-up period of an interventional study.
• \) Subjects with an insufficient washout period from the previous anti-tumor therapy to the first dose.
• \) Subjects who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.
• \) Subjects who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.
• \) Subjects who received allogeneic bone marrow transplantation or solid organ transplantation.
• \) Subjects who received systemic steroids or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational drug.
• \) Subjects who received any live vaccine within 4 weeks prior to the first dose or those who plan to receive live vaccines during the study.
• \) Subjects with a medical history of leptomeningeal carcinoma or cancerous meningitis.
• \) Subjects with brain metastasis or spinal cord compression. 12) Subjects with uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
• \) Subjects who were diagnosed with Gilbert's syndrome. 14) Subjects with significantly symptomatic or unstable effusion in the third space requiring repeated drainage.
• \) Subjects with medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric ulcers, duodenal ulcer, colitis ulcerative, or other gastrointestinal disorders that may cause hemorrhage or perforation in the opinion of the investigator.
• \) Subjects with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to the first dose.
• \) Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; subjects with positive syphilis antibody and a positive titer result.
• \) Subjects with unresolved toxicity caused by previous anti-tumor therapy. 20) Subjects with a history of serious allergic reactions to drugs, inactive ingredients in drug products, or other monoclonal antibodies.
• \) Female subjects who are pregnant as confirmed by a pregnancy test within 3 days prior to the first dose, or lactating women.
• \) Subjects who have any diseases, medical conditions, organ system dysfunction, or social conditions.
• \) Subjects with multiple primary malignancies within 5 years prior to the signing of the ICF, except for fully resected non-melanoma skin cancer, radically treated carcinoma in situ, or other radically treated solid tumors.