OncoMatch/Clinical Trials/NCT06042894
A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer
Is NCT06042894 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BL-B01D1 and SI-B003 for breast cancer.
Treatment: BL-B01D1 · SI-B003 — This phase II study is a clinical study to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with unresectable locally advanced or recurrent metastatic HER-2 negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
HER2-negative breast cancer
Disease stage
Metastatic disease required
unresectable, locally advanced or recurrent, metastatic HER2-negative breast cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
patients who have failed standard treatment, or have no access to standard treatment
Cannot have received: ADC drugs with topoisomerase I inhibitors (camptothecins) as small molecule toxins
ADC drugs that have received topoisomerase I inhibitors (camptothecins) as small molecule toxins
Lab requirements
Blood counts
hemoglobin ≥90g/L; absolute neutrophil count ≥1.5×10^9/L; platelet count ≥90×10^9/L
Kidney function
creatinine ≤1.5 ULN, or creatinine clearance ≥50 mL/min
Liver function
total bilirubin ≤1.5 ULN, ALT and AST ≤2.5 ULN in all patients, and AST and ALT ≤5.0 ULN in patients with liver metastasis
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) ≥ 90× 10 9 /L; Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min; Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) was ≤2.5 ULN in all patients, and AST and ALT were ≤ in patients with liver metastasis 5.0 ULN; ... no severe cardiac dysfunction with left ventricular ejection fraction ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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