Actively Recruiting
A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
58
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow study requirements
- Age between 18 and 75 years old
- Expected survival time of at least 3 months
- ECOG performance status 0 or 1
- Diagnosed with unresectable locally advanced or recurrent metastatic HER2-negative breast cancer after prior treatments
- Agree to provide archived tumor tissue samples from primary or metastatic sites within 2 years
- Have at least one measurable lesion according to RECIST v1.1 criteria
- No blood transfusions or use of growth factors within 14 days before screening
- Meet specific blood, kidney, liver, coagulation, and heart function levels as defined in the protocol
- Toxicity from previous cancer treatments must have returned to grade 1 or less
- Negative pregnancy test for premenopausal women, not lactating, and agree to use adequate contraception during and 6 months after treatment
You will not qualify if you...
- Prior treatment with ADC drugs containing topoisomerase I inhibitors
- Received chemotherapy, immunotherapy, radiotherapy, surgery, or targeted therapy within specified recent timeframes before first dose
- Use of immunomodulatory drugs within 14 days before first study drug use
- Use of systemic corticosteroids above defined doses
- History of severe immune-related adverse events from immunotherapy
- Severe cardiovascular or cerebrovascular diseases as described in the protocol
- Active autoimmune or inflammatory diseases requiring systemic treatment
- Other malignancies progressing or needing treatment within 3 years except certain skin cancers
- History or current interstitial lung disease or pulmonary inflammation requiring steroids
- Poorly controlled diabetes or hypertension, or history of hypertensive crisis
- Recent unstable thrombotic events within 6 months before screening
- Presence of central nervous system metastases or carcinomatous meningitis unless stable brain metastases
- Presence of symptomatic pleural, pericardial effusion or ascites
- Allergy to recombinant humanized or human-mouse chimeric antibodies or study drug excipients
- Prior organ or stem cell transplantation
- Positive for HIV, active tuberculosis, or active hepatitis C infection
- Active hepatitis B infection unless treated and under antiviral therapy
- Active infections requiring systemic treatment
- Participation in another clinical trial within 4 weeks before first dose
- History of psychotropic drug abuse or mental disorders preventing study participation
- Any condition the investigator judges unsuitable for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
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
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