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

Launched by SICHUAN BAILI PHARMACEUTICAL CO., LTD. · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma, and other solid tumors. The study is testing a combination of two drugs: BL-B01D1 and a PD-1 monoclonal antibody, to see how well they work together and how safe they are for patients. The trial is currently looking for participants who are at least 18 years old, have been diagnosed with one of the targeted cancers, and have a good chance of survival for at least three months.

Eligible participants will need to provide some past tumor samples and have at least one tumor that can be measured. During the trial, participants will receive the study treatment and will be monitored for any side effects or benefits from the drugs. It’s important to note that there are specific health criteria that need to be met to ensure safety, such as having no serious heart issues and stable overall health. If you or a loved one are considering participation, this trial could offer access to potentially effective new treatments while contributing to cancer research.

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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.