A Study of BL-M08D1 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma and Other Solid Tumors

Inclusion criteria

• Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
• No gender restriction;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Recurrent or metastatic nasopharyngeal carcinoma and other solid tumors;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within 3 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose;
• Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• Organ function levels must meet the required criteria;
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);
• Urine protein ≤1+ or ≤1000 mg/24h;
• For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment and must be negative, and they must be non-lactating; all enrolled patients (both male and female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;
• The trial participant must be capable of and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.

Exclusion criteria

• Use of chemotherapy, biotherapy, immunotherapy, or other systemic anti-cancer therapies within 4 weeks or 5 half-lives prior to the first dose;
• History of severe cardiac or cerebrovascular disease;
• Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of another primary malignancy within 5 years prior to the first dose;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
• Hypertension inadequately controlled by antihypertensive medications;
• Poorly controlled blood glucose (diabetes);
• History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of Grade ≥2;
• Severely impaired respiratory function;
• Active central nervous system (CNS) metastases;
• History of, or concurrent, central nervous system disorders;
• History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or hypersensitivity to any excipient component of BL-M08D1;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Active infection requiring systemic therapy within 4 weeks prior to the first dose of study drug;
• Pleural, peritoneal, or pericardial effusion requiring drainage and/or associated with symptoms within 4 weeks prior to the first dose of study drug;
• Imaging findings indicating that the tumor has invaded or encased major blood vessels (e.g., abdominal or thoracic vessels), the pericardium, or the heart;
• Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
• Pregnant or breastfeeding women;
• Other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in this clinical trial.