A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors

This Phase Ib/II study is a clinical study to explore the efficacy and safety of BL-M08D1 for injection in patients with locally advanced or metastatic melanoma and other solid tumors.

Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with protocol requirements; 2. No restriction on gender; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Locally advanced or metastatic melanoma and other solid tumors; 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. ECOG performance status score of 0 or 1, with no deterioration within 2 weeks before the first dose; 9. Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. Organ function levels must meet the requirements; 12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 ULN; 13. Urine protein ≤1+ 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 they must be non-lactating; all enrolled patients (whether male or female) should use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment ends; 15. Trial participants are able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol. Exclusion Criteria: 1. Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose; 2. History of severe heart disease or cerebrovascular disease; 3. QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias; 4. Active autoimmune diseases and inflammatory diseases; 5. Diagnosis of other malignancies within 5 years before the first dose; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose; 7. Hypertension poorly controlled by antihypertensive drugs; 8. Patients with poorly controlled blood glucose; 9. History of interstitial lung disease requiring hormone therapy, or current ILD or grade \>= 2 radiation pneumonitis; 10. Severe impairment of respiratory function; 11. Active central nervous system metastasis; 12. Previous or concomitant central nervous system lesions; 13. Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M08D1; 14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 16. Presence of active infection requiring systemic treatment within 4 weeks before the first study drug administration; 17. Presence of pleural, abdominal, pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks before the first study drug administration; 18. Imaging examination suggesting that the tumor has invaded or encased the abdomen, chest, neck, etc.; 19. Use of another clinical trial drug within 4 weeks or 5 half-lives before the first dose; 20. Pregnant or breastfeeding women; 21. Other circumstances in which the investigator considers the patient unsuitable for participation in this clinical trial.