Combining BL-B01D1 and PD-1 Antibody for Advanced Lung and Nasopharyngeal Cancers

A Phase II Clinical Trial to Evaluate the Efficacy and Safety 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

This study is testing a new combination of two cancer treatments to see if it can help people with advanced lung and nasopharyngeal cancers feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 570 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06475300 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial investigates the safety and efficacy of the combination of BL-B01D1 and a PD-1 monoclonal antibody in patients suffering from locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma, and other solid tumors. Participants must provide tumor tissue samples and have measurable lesions as defined by RECIST criteria. The study aims to determine if this combination therapy can improve patient outcomes compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma.

Not a fit: Patients with serious cardiac dysfunction or those who have not recovered from previous antineoplastic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced lung and nasopharyngeal cancers.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this novel combination.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Li Zhang — Sun Yat-Sen University Cancer Center
• Study coordinator: Sa Xiao, PHD

Conditions Non-small Cell Lung Cancer; Nasopharyngeal Carcinoma; Solid Tumor