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Trial Title:
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
NCT ID:
NCT06437509
Condition:
Extensive-stage Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
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:
Study treatment
Intervention type:
Drug
Intervention name:
PD-1 monoclonal antibody
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Study treatment
Summary:
This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 +
PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell
lung cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subject volunteered to participate in the study and signed an informed consent;
2. Male or female aged ≥18 years and ≤75 years;
3. Expected survival time ≥3 months;
4. ECOG score 0-1;
5. Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by
histopathology and / or cytology;
6. A archived tumor tissue sample or fresh tissue sample of the primary or metastatic
lesion must be provided within 3 years;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs
within 14 days before screening, and the organ function level must meet the
requirements;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined
by NCI-CTCAE v5.0;
10. For premenopausal women of childbearing potential, a pregnancy test must be
performed within 7 days before the initiation of treatment, a serum or urine
pregnancy test must be negative, and the patient must not be lactating; All enrolled
patients should take adequate barrier contraception during the entire treatment
cycle and for 6 months after the end of treatment.
Exclusion Criteria:
1. Prior use of ADC drug therapy with small molecule toxins as topoisomerase I
inhibitors;
2. Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell
lung cancer;
3. Pathology suggested small cell carcinoma containing non-small cell carcinoma
components;
4. Subjects had used immunomodulatory drugs within 14 days before the first use of the
study drug ;
5. Screening the history of severe cardiovascular and cerebrovascular diseases in the
first half of the year ;
6. QT interval prolongation, complete left bundle branch block, III degree
atrioventricular block, frequent and uncontrollable arrhythmia ;
7. Active autoimmune diseases and inflammatory diseases ;
8. Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory
active drugs or any form of immunosuppressive therapy prior to the first dose;
9. Other malignancies that have progressed or require treatment within 5 years prior to
the first dose;
10. Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at
screening;
11. Prior to initiation of study treatment, there were: a) poorly controlled diabetes
mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin
levels of 8% or more; d) hypertension that is poorly controlled by two
antihypertensive drugs; e) history of hypertensive crisis or hypertensive
encephalopathy;
12. Unstable thrombotic events requiring therapeutic intervention within 6 months prior
to screening; Except for infusion set-related thrombosis;
13. Concurrent pulmonary disease leading to severe clinical impairment of respiratory
function;
14. Patients with active central nervous system metastases;
15. Patients with large serosal effusions, or symptomatic serosal effusions, or poorly
controlled serosal effusions;
16. History of allergy to recombinant humanized antibody or human-mouse chimeric
antibody or to any excipient component of the experimental drug;
17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
18. Positive human immunodeficiency virus antibody, active tuberculosis, active
hepatitis B virus infection, or active hepatitis C virus infection;
19. Severe infection within 4 weeks prior to first dose of study drug; Lung infection or
active lung inflammation within 4 weeks;
20. Have participated in another clinical trial within 4 weeks prior to the first dose;
21. Have a history of psychotropic substance abuse and cannot be abstained from or have
a history of severe neurological or psychiatric disorders;
22. Imaging examination showed that the tumor had invaded or encapsulated the large
blood vessels in the chest;
23. Severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing
the informed policy;
24. Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to
signing the informed policy;
25. Subjects who are scheduled to receive or receive a live vaccine within 28 days prior
to the first dose;
26. Other conditions that the investigator considers unsuitable to participate in this
clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou
Start date:
June 13, 2024
Completion date:
June 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/NCT06437509
