A Study of BL-B01D1 With or Without PD-1 Monoclonal Antibody in Patients With High-Risk Locally Advanced Nasopharyngeal Carcinoma

Inclusion criteria

• No gender restriction;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Pathologically confirmed as newly diagnosed nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)";
• Patients with locally regionally advanced nasopharyngeal carcinoma;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 1 year, or fresh tissue samples;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• Organ function levels must meet the required criteria;
• Urine protein ≤1+ or ≤1000 mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment; serum pregnancy test must exclude pregnancy, and patients must be non-lactating; all enrolled trial participants (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the completion of treatment.

Exclusion criteria

• Prior receipt of any anti-tumor systemic therapy regimen for nasopharyngeal carcinoma；
• Use of modern traditional Chinese medicine preparations that have been approved by the NMPA for anti-tumor therapy within 2 weeks prior to the first dose；
• History of severe cardiac or cerebrovascular disease；
• Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias；
• Active autoimmune diseases and inflammatory diseases；
• Diagnosis of active malignancy within 3 years prior to study randomization；
• Hypertension inadequately controlled by two antihypertensive agents；
• Trial participants with poorly controlled blood glucose；
• History of interstitial lung disease/interstitial pneumonia requiring corticosteroid therapy, etc.；
• Concurrent pulmonary disease resulting in severe impairment of respiratory function；
• Trial participants with massive serous cavity effusion, or symptomatic serous cavity effusion, or serous cavity effusion that is poorly controlled；
• Imaging findings indicating tumor invasion or encasement of major blood vessels in the neck, pharynx, or other regions；
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening；
• Trial participants with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-B01D1；
• Prior history of 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；
• Severe infection occurring within 4 weeks prior to the first use of the investigational drug；
• History of psychotropic substance abuse that cannot be abstained from, or history of severe neurological or psychiatric disorders；
• Severe and unhealed wounds, ulcers, or fractures within 4 weeks prior to signing informed consent；
• Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first dose of the investigational drug；
• Trial participants with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.；
• Trial participants who plan to receive or have received live vaccines within 28 days prior to study randomization；
• Other conditions that, in the investigator's judgment, make the participant unsuitable for participation in this clinical trial due to complications or other reasons.