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Trial Title:
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
NCT ID:
NCT06475300
Condition:
Non-small Cell Lung Cancer
Nasopharyngeal Carcinoma
Solid Tumor
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B01D1
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
BL-B01D1+PD-1 Monoclonal Antibody
Intervention type:
Drug
Intervention name:
PD-1 Monoclonal Antibody
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
BL-B01D1+PD-1 Monoclonal Antibody
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhang
Start date:
June 25, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06475300
