Actively Recruiting
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-05-07
52
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.
CONDITIONS
Official Title
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and agree to follow the study protocol
- Age between 18 and 75 years old
- Expected survival time of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer
- No prior systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer
- Provide archived or fresh tumor tissue from primary or metastatic lesion collected within the past 2 years
- Have at least one measurable lesion according to RECIST v1.1 criteria
- No blood transfusion or use of cell growth factors/platelet raising drugs within 14 days before screening
- Previous antineoplastic therapy toxicity recovered to grade 1 or less per NCI-CTCAE v5.0
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment start, not lactating, and agree to use adequate barrier contraception during treatment and for 6 months after
You will not qualify if you...
- Prior treatment with ADC drugs containing topoisomerase I inhibitors as small molecule toxins
- Palliative radiotherapy within 2 weeks before first dose
- Use of checkpoint inhibitors before neoadjuvant or adjuvant chemotherapy
- Use of immunomodulatory drugs within 14 days before first dose
- History of severe cardiovascular or cerebrovascular disease in the past 6 months
- QT prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrolled arrhythmia
- Active autoimmune or inflammatory diseases
- Long-term systemic corticosteroid therapy before first dose
- Other malignant tumors that progressed or required treatment within 5 years before first dose
- Poorly controlled diabetes, severe diabetic complications, HbA1c 8% or higher, poorly controlled hypertension on two drugs, or history of hypertensive crisis
- Grade 2 or higher radiation pneumonitis or current interstitial lung disease
- Pulmonary diseases causing severe respiratory impairment
- Unstable thrombotic events requiring treatment within 6 months before screening
- Active central nervous system metastases
- Massive, symptomatic, or poorly controlled effusions
- Allergic history to recombinant humanized or human-mouse chimeric antibodies or drug excipients
- Prior organ or allogeneic hematopoietic stem cell transplantation
- HIV positive, active tuberculosis, hepatitis B or C infection
- Serious infection or active pulmonary inflammation within 4 weeks before first dose
- Participation in another clinical trial within 4 weeks before first dose
- Superior vena cava syndrome requiring rehydration
- History of psychotropic substance abuse or severe neurological/psychiatric illness
- Tumor invasion or encasement of large thoracic vessels
- Serious unhealed wound, ulcer, or fracture within 4 weeks before informed consent
- Clinically significant bleeding or bleeding tendency within 4 weeks before informed consent
- Scheduled to receive or received live vaccine within 28 days before first dose
- Other conditions deemed inappropriate by investigator 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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