OncoMatch/Clinical Trials/NCT05924841
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer
Is NCT05924841 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including BL-B01D1 and SI-B003 for small cell lung cancer.
Treatment: BL-B01D1 · SI-B003 — This phase II study is designed to investigate 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Excluded: EGFR monoclonal antibody therapy
Previous treatment with EGFR and HER3 monoclonal antibodies
Excluded: ERBB3 monoclonal antibody therapy
Previous treatment with EGFR and HER3 monoclonal antibodies
Disease stage
Required: Stage IV (VALG)
Patients with extensive-stage small-cell Lung cancer confirmed by histopathology and/or cytology (according to Veterans Administration Lung Study Group (VALG) staging)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic antitumor therapy — Cohort_A: failed or intolerant to 3 or more lines
Cohort_A cohort of patients with extensive-stage small cell lung cancer who had failed or were intolerant to 3 or more lines of systemic antitumor therapy
Must have received: standard therapy — Cohort_B Stage I: previous failure or intolerance
Cohort_B Stage I subjects with previous failure or intolerance to standard therapy for extensive-stage small cell lung cancer
Cannot have received: EGFR monoclonal antibody
Previous treatment with EGFR and HER3 monoclonal antibodies
Cannot have received: HER3 monoclonal antibody
Previous treatment with EGFR and HER3 monoclonal antibodies
Cannot have received: antineoplastic therapy
Exception: within 4 weeks or 5 half-life cycles (whichever is shorter) before the first dose; oral fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks before the first dose
Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors), has been administered within 4 weeks or 5 half-life cycles (whichever is shorter) before the first dose; Oral fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks before the first dose
Cannot have received: systemic therapy
Cohort_B Stage II patients who had received any previous systemic therapy for extensive-stage SCLC were not eligible for the study
Cannot have received: immunotherapy
Exception: Cohort_B only; history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis
Cohort_B with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis, excluded
Cannot have received: immunomodulatory drugs (thymosin, interleukin-2, interferon)
Exception: Cohort_B only; within 14 days before the first dose
Cohort_B with history of use of immunomodulatory drugs (including but not limited to thymosin, interleukin-2, interferon, etc.) within 14 days before the first dose of study drug was excluded
Lab requirements
Blood counts
hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥ 1.5×10^9/L; Platelet count (PLT) ≥ 100×10^9/L
Kidney function
creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula)
Liver function
total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≤2.5 ULN, and AST and ALT were both ≤5.0 ULN when liver metastasis was present
Cardiac function
no severe cardiac dysfunction with left ventricular ejection fraction ≥50%
Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥ 1.5×10 9 /L; Platelet count (PLT) ≥ 100×10 9 /L; Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula). Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≤2.5 ULN, and AST and ALT were both ≤5.0 ULN when liver metastasis was present; coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5ULN; no severe cardiac dysfunction with left ventricular ejection fraction ≥50%; proteinuria ≤2+ or ≤1000mg/24h
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05924841 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR monoclonal antibody, HER3 monoclonal antibody, antineoplastic therapy disqualifies patients from enrollment.
Are patients with EGFR alterations eligible?
No. EGFR monoclonal antibody therapy is an exclusion criterion.
Are patients with ERBB3 alterations eligible?
No. ERBB3 monoclonal antibody therapy is an exclusion criterion.
What disease stage is eligible?
Stage IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages