A Study of BL-M08D1 in Patients With Locally Advanced or Metastatic Solid Tumors

Inclusion criteria

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Gender is not limited;
• Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);
• Expected survival time ≥3 months;
• Locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that are incurable or currently have no standard treatment;
• Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• No blood transfusion, no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
• Urinary protein ≤2+ or ≤1000mg/24h;
• For premenopausal women with 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 lactating; All enrolled patients (regardless of male or female) should use adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment;
• Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Exclusion criteria

• Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
• History of severe heart disease;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block;
• Active autoimmune and inflammatory diseases;
• Other malignant tumors diagnosed within 5 years before the first dose;
• Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);
• History of ILD requiring steroid therapy or current ILD or ≥ grade 2 radiation pneumonitis;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Had symptoms of active central nervous system metastasis;
• Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M08D1;
• Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
• Active infection requiring systemic therapy within 4 weeks before the first dose of study drug;
• Pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug;
• Received another trial drug 4 weeks or 5 half-lives before the first dose;
• Pregnant or lactating women;
• The investigator did not consider it appropriate to apply other criteria for participation in the trial.