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Trial Title:
A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT ID:
NCT05880706
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Osimertinib
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
Arm group label:
Study treatment
Intervention type:
Drug
Intervention name:
Osimertinib Mesylate Tablets
Description:
Osimertinib Mesylate Tablets will be administered at a fixed dose of 80mg daily.
Arm group label:
Study treatment
Summary:
A Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 for injection
and BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally
advanced or metastatic non-small cell lung cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Gender is not limited;
3. Age ≥18 years old;
4. Expected survival time ≥3 months;
5. Patients with locally advanced or metastatic non-small cell lung cancer confirmed by
histopathology and/or cytology;
6. Consent to provide an archived tumor tissue sample or fresh tissue sample from the
primary or metastatic site within 6 months for biomarker testing;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. ECOG ≤1;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined
by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. The level of organ function must meet the requirements on the premise that no blood
transfusion and no use of any cell growth factor drugs are allowed within 14 days
before the screening period;
12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated
partial thromboplastin time (APTT) ≤1.5×ULN;
13. Urinary protein ≤2+ or ≤1000mg/24h;
14. Fertile female subjects, or male subjects with fertile partners, must use highly
effective contraception from 7 days before the first dose until 6 months after the
first dose. Female subjects of childbearing potential had to have a negative serum
pregnancy test within 7 days before the first dose.
Exclusion Criteria:
1. Patients with previous systemic therapy;
2. Cohort_B and Cohort_C were previously treated with EGFR-TKI;
3. Who had participated in any other clinical trial within 4 weeks before the study
dose;
4. Received chemotherapy, radiotherapy, biological therapy, immunotherapy and other
anti-tumor treatments within 4 weeks before the first use of study drugs;
5. Had undergone major surgery within 4 weeks before the first dose;
6. History of severe heart disease and cerebrovascular disease;
7. Unstable thrombotic events requiring therapeutic intervention within 6 months before
screening;
8. QT prolongation, complete left bundle branch block, III degree atrioventricular
block, frequent and uncontrollable arrhythmia;
9. Current interstitial lung disease, drug-induced interstitial pneumonia, radiation
pneumonitis requiring steroid therapy, or a history of these diseases;
10. Complicated with pulmonary diseases leading to clinically severe respiratory
function impairment;
11. Severe systemic infection within 4 weeks before screening;
12. Patients at risk for active autoimmune disease or with a history of autoimmune
disease;
13. Complicated with other malignant tumors within 5 years before the first dose of
medication;
14. Human immunodeficiency virus antibody positive, active tuberculosis, active
hepatitis B virus infection or hepatitis C virus infection;
15. Hypertension poorly controlled by two antihypertensive drugs;
16. Patients with poor glycemic control;
17. Patients with massive effusions, or effusions with obvious symptoms, or poorly
controlled effusions;
18. Patients with active central nervous system metastases;
19. Imaging examination showed that the tumor had invaded or enveloped the large blood
vessels in the abdomen, chest, neck, and pharynx;
20. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed
consent;
21. Subjects with clinically significant bleeding or obvious bleeding tendency within 4
weeks before signing the informed consent;
22. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
23. Patients with a history of allergy to recombinant humanized antibody or to any of
the excipients of BL-B01D1;
24. Had a history of severe neurological or psychiatric disorders;
25. Had a history of autologous or allogeneic stem cell transplantation;
26. Pregnant or lactating women;
27. Subjects scheduled for vaccination or who received live vaccine within 28 days
before study randomization;
28. Other conditions for participation in the trial were not considered appropriate by
the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Gui
Phone:
021-65115006-1019
Email:
fkyygcp@163.com
Investigator:
Last name:
Caicun Zhou, PHD
Email:
Principal Investigator
Start date:
July 19, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
Sichuan Baili 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/NCT05880706
