Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Nasopharyngeal Carcinoma
Solid Tumor
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
First posted: 2024-06-26
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 24 months
measure: Recommended Phase II Dose (RP2D)
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 24 months
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 24 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 24 months
measure: Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang
role: PRINCIPAL_INVESTIGATOR
References: