Actively Recruiting
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-05-07
66
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteered to participate and signed informed consent
- Male or female aged 18 to 75 years
- Expected survival time of at least 3 months
- ECOG performance status of 0 or 1
- Newly diagnosed with extensive-stage small cell lung cancer confirmed by histopathology or cytology
- Provide an archived or fresh tumor tissue sample from the primary or metastatic lesion within 3 years
- Have at least one measurable lesion according to RECIST v1.1
- No blood transfusion or use of cell growth factors/platelet-raising drugs within 14 days before screening, and organ function meets requirements
- Toxicity from previous antineoplastic therapy has returned to grade 1 or less per NCI-CTCAE v5.0
- For premenopausal women of childbearing potential, negative pregnancy test within 7 days before treatment start, not lactating, and use of effective contraception during treatment and for 6 months after
You will not qualify if you...
- Prior use of antibody-drug conjugate therapy with small molecule toxins as topoisomerase I inhibitors
- Previous systemic anti-tumor treatment for extensive-stage small cell lung cancer
- Small cell carcinoma containing non-small cell carcinoma components
- Use of immunomodulatory drugs within 14 days before starting study drug
- History of severe cardiovascular or cerebrovascular disease within the last 6 months
- QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrollable arrhythmia
- Active autoimmune or inflammatory diseases
- Long-term systemic corticosteroid or other immunosuppressive treatment before first dose
- Other malignancies that progressed or required treatment within 5 years prior to first dose
- Interstitial lung disease needing steroid therapy, current or suspected ILD at screening
- Poorly controlled diabetes or hypertension, or severe diabetic complications
- Unstable thrombotic events requiring treatment within 6 months before screening
- Severe pulmonary disease causing major respiratory impairment
- Active central nervous system metastases
- Large, symptomatic, or poorly controlled serosal effusions
- Allergy to recombinant humanized or human-mouse chimeric antibodies or any study drug components
- Prior organ or hematopoietic stem cell transplantation
- Positive for HIV antibody, active tuberculosis, or active hepatitis B or C infection
- Severe infection within 4 weeks before first dose, including lung infection or active lung inflammation
- Participation in another clinical trial within 4 weeks before first dose
- History of psychotropic substance abuse or severe neurological/psychiatric disorders
- Tumor invasion or encapsulation of large chest blood vessels
- Severe non-healing wounds, ulcers, or fractures within 4 weeks before consent
- Clinically significant bleeding or bleeding tendency within 4 weeks before consent
- Planned or received live vaccine within 28 days prior to first dose
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here