NCT06475300 A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 570 participants in total. It began in 2024-06-25 with a primary completion date of 2027-06.

Brief Summary

This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.

Eligibility Criteria

Inclusion Criteria: 1. Sign the informed consent form voluntarily and follow the protocol requirements; 2. Any gender; 3. Age: ≥18 years old; 4. Expected survival time for 3 months or more; 5. Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology; 6. Subjects were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. ECOG 0 or 1; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. No serious cardiac dysfunction, left ventricular ejection fraction 50% or higher; 11. screening period not allowed within 14 days before a blood transfusion, are not allowed to use any cell growth factor, and/or liters of platelet medicine, organ function level must conform to the requirements; 12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN; 13. The urine protein + 2 or 1000 mg / 24 h or less or less; 14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy; 2. In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion; 3. Anti-tumor therapy such as chemotherapy or biological therapy has 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; Fluorouracil class oral drugs, etc.; 4. Serious heart disease; 5. Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia; 6. Active autoimmune and inflammatory diseases; 7. Before the first delivery within 5 years diagnosed as other malignant tumor; 8. Two antihypertensive drugs poorly controlled hypertension; 9. Patients with poor glycemic control; 10. With a history of ILD, current ILD or suspected suffering from such diseases during screening; 11. Complicated with pulmonary diseases leading to severe respiratory function impairment; 12. There is a lot of serous cavity effusion, or have a serous cavity effusion and has symptoms, or poorly controlled serous cavity effusion patients; 13. Imaging studies suggest tumor has violated or package around the chest, neck, pharyngeal large blood vessels; 14. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded; 15. Active central nervous system of patients; 16. For restructuring or human mouse chimeric antibody on study of humanized anti-platelet antibody has a history of allergies or allergic to BL - B01D1 any supplementary material composition of patients; 17. Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT); 18. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection; 19. Active infection requiring systemic therapy; 20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 21. Had participated in another clinical trial within 4 weeks before the first dose; 22. Other conditions for trial participation were not considered appropriate by the investigator.

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