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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06042894 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ADC drugs with topoisomerase I inhibitors (camptothecins) as small molecule toxins disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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