A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with protocol requirements; 2. No gender restriction; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that have failed or are intolerant to standard treatment, or for which no standard treatment currently exists; 6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years or fresh tissue samples; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 9. Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v5.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 11. Organ function levels must meet the requirements under the premise that no blood transfusion and no use of any cell growth factors and/or platelet-elevating agents are allowed within 14 days before screening assessments; 12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 ULN; 13. Urine protein ≤2+ or ≤1000 mg/24 h; 14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be breastfeeding; all enrolled patients (whether male or female) must use adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the end of treatment. Exclusion Criteria: 1. Prior antitumor therapy such as chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives before the first dose; mitomycin and nitrosoureas within 6 weeks before the first dose; oral fluorouracil drugs or palliative radiotherapy within 2 weeks before the first dose; Chinese patent medicines within 2 weeks before the first dose; 2. History of severe cardiovascular or cerebrovascular disease; 3. QT interval prolongation, complete left bundle branch block, grade III atrioventricular block, frequent and uncontrollable arrhythmias; 4. Active autoimmune disease and inflammatory disease; 5. Diagnosis of other malignancies within 5 years before the first dose; 6. Hypertension inadequately controlled with two antihypertensive drugs; 7. History of ILD, or current radiation pneumonitis, or suspected such disease; 8. Pulmonary disease defined as grade ≥2 according to CTCAE v5.0; concurrent pulmonary disease causing clinically severe respiratory impairment; 9. Patients with poorly controlled blood glucose; 10. Patients with active central nervous system metastases; 11. Patients with massive serous cavity effusion, or serous cavity effusion with symptoms, or inadequately controlled serous cavity effusion; 12. Imaging examination indicating that the tumor has invaded or encased major vessels in the chest, neck, pharynx, etc.; 13. History of pulmonary embolism or thrombotic events requiring therapeutic intervention within 6 months before screening; infusion device-related thrombosis excluded; 14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M05D1; 15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 16. Cumulative anthracycline dose \>360 mg/m2 in prior (neo)adjuvant anthracycline therapy; 17. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 18. Active infection requiring systemic treatment; 19. Participation in another clinical trial within 4 weeks before the first dose; 20. Pregnant or breastfeeding women; 21. Esophageal or gastric varices requiring intervention within the past three months or diseases with a high risk of bleeding; 22. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection, etc.; 23. Other circumstances in which the investigator considers the patient unsuitable for participation in this clinical trial.