BL-M08D treatment in 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.