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

Inclusion criteria

• Voluntarily sign the informed consent form and comply with protocol requirements;
• No restriction on gender;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Locally advanced or metastatic melanoma and other solid tumors;
• Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years or fresh tissue samples;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1, with no deterioration within 2 weeks before the first dose;
• Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 ULN;
• Urine protein ≤1+ or ≤1000 mg/24 h;
• 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;
• 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

• Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose;
• History of severe heart disease or cerebrovascular disease;
• QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of other malignancies within 5 years before the first dose;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose;
• Hypertension poorly controlled by antihypertensive drugs;
• Patients with poorly controlled blood glucose;
• History of interstitial lung disease requiring hormone therapy, or current ILD or grade >= 2 radiation pneumonitis;
• Severe impairment of respiratory function;
• Active central nervous system metastasis;
• Previous or concomitant central nervous system lesions;
• Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M08D1;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Presence of active infection requiring systemic treatment within 4 weeks before the first study drug administration;
• 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;
• Imaging examination suggesting that the tumor has invaded or encased the abdomen, chest, neck, etc.;
• Use of another clinical trial drug within 4 weeks or 5 half-lives before the first dose;
• Pregnant or breastfeeding women;
• Other circumstances in which the investigator considers the patient unsuitable for participation in this clinical trial.