Actively Recruiting
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Extensive Stage Small Cell Lung Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of three treatments—BL-B01D1 alone, SI-B003 alone, and their combination—in patients with extensive-stage small cell lung cancer. This is a phase II clinical trial aimed at understanding how these treatments work individually and together in this patient group. The study is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. Participants will receive one of the three treatments during a first cycle lasting three weeks, administered by intravenous infusion. Those who benefit from the initial treatment may continue receiving additional cycles. Treatment will stop if the disease worsens, toxicity becomes intolerable, or for other reasons determined by the study. Throughout the study, researchers will measure how many patients respond to treatment and the recommended dose for phase II, over about 24 months. They will also monitor disease progression, control rates, response duration, and any adverse events. Patients will undergo assessments such as tumor tissue sampling and regular health evaluations to track outcomes and safety during this period.
CONDITIONS
Brief Title
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign 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
- Confirmed extensive-stage small cell lung cancer by histopathology and/or cytology
- For Cohort_A: patients who failed or are intolerant to 3 or more lines of systemic antitumor therapy
- For Cohort_B Stage I: patients with previous failure or intolerance to standard therapy
- For Cohort_B Stage II: patients without previous systemic antitumor therapy
- Consent to provide archival or fresh tumor tissue samples within 3 years or meet alternative criteria
- At least one measurable lesion as defined by RECIST v1.1
- Adequate organ function including blood, renal, liver, coagulation, and cardiac function
- Toxicity from previous treatments returned to grade 1 or less (with some exceptions)
- Negative pregnancy test for premenopausal women and use of barrier contraception during treatment and 6 months after
You will not qualify if you...
- Previous treatment with EGFR and HER3 monoclonal antibodies
- Recent antineoplastic therapy within defined washout periods before first dose
- Cohort_B Stage II patients with prior systemic therapy for extensive-stage SCLC
- History of severe immune-related adverse events or myocarditis related to immunotherapy
- Recent use of immunomodulatory drugs before study drug
- History of severe cardiovascular or cerebrovascular diseases within 6 months
- Active autoimmune or inflammatory diseases requiring systemic treatment
- Other malignant tumors requiring treatment within 5 years, with some exceptions
- History or current interstitial lung disease or pulmonary inflammation requiring steroids
- Poorly controlled diabetes or hypertension or history of hypertensive crisis
- Unstable thrombosis or embolism requiring medical intervention within 6 months
- Central nervous system metastases or carcinomatous meningitis (with some exceptions)
- Symptomatic pleural, pericardial effusions, or ascites needing repeated drainage
- Allergy to recombinant humanized or human-mouse chimeric antibodies or study drug components
- Prior organ or allogeneic stem cell transplantation
- Active infections including HIV, tuberculosis, hepatitis B or C
- Participation in another clinical trial within 4 weeks before first dose
- History of psychotropic drug abuse or mental disorders affecting participation
- Any other condition deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive BL-B01D1 monotherapy, SI-B003 monotherapy, or BL-B01D1 plus SI-B003 combination therapy administered by intravenous infusion in repeated 3-week cycles. Treatment continues until disease progression, intolerable toxicity, or other reasons for discontinuation.
1 visit per cycle (in-person)
Trial Site Locations
Total: 1 location
1
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
S
Sa Xiao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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