A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Exclusion Criteria

• •1. Antineoplastic therapy 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;
• •2. History of severe heart disease;
• •3. QT prolongation, complete left bundle branch block, III degree atrioventricular block;
• •4. Active autoimmune and inflammatory diseases;
• •5. Before the first delivery within 5 years diagnosed as other malignant tumor;
• •6. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• •7. Patients with poor glycemic control;
• •8. Present with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD or current ILD, or suspicion of such disease during screening;
• •9. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• •10. There is activity of the central nervous system symptoms;
• •11. Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B16D1;
• •12. Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);
• •13. Previous anthracycline-based adjuvant therapy (new), the cumulative dose anthracycline-based drugs \> 360 mg/m2;
• •14. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
• •15. Severe infection occurred within 4 weeks before the first dose; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;
• •16. Patients with massive or symptomatic effusions or poorly controlled effusions;
• •17. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
• •18. Had the following ocular diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. Contact lens dependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy, wet macular degeneration, etc.;
• •19. Other circumstances that the investigator deemed inappropriate for participation in the trial.