Actively Recruiting
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy 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
N/A
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
Researchers are evaluating the combination of BL-B01D1 and a PD-1 monoclonal antibody in patients with triple-negative breast cancer that cannot be removed by surgery or has returned after treatment and spread to other areas. This phase II clinical trial aims to explore the safety and effectiveness of this combination therapy, addressing an advanced and challenging form of breast cancer. Participants receive the study drugs through intravenous infusion during a 3-week treatment cycle. BL-B01D1 is given on day 1 and day 8, while the PD-1 monoclonal antibody is administered once every 3 weeks. Those who benefit from the treatment may continue receiving additional cycles until disease progression, unacceptable side effects, or other reasons require stopping therapy. During the study, participants will undergo regular evaluations to assess tumor response, progression-free survival, disease control, and treatment side effects for up to about 24 months. Researchers will collect tumor tissue samples and monitor health status, adverse events, and overall response. The goal is to determine the recommended dose and measure how well patients respond to the combination therapy over time.
CONDITIONS
Brief 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 follow the study protocol
- Aged 18 to 75 years old
- Expected survival time of at least 3 months
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed inoperable 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 specimen from the primary or metastatic lesion within 2 years
- Have at least one measurable lesion as defined by RECIST v1.1
- No blood transfusion or use of growth factors within 14 days before screening; organ function must meet requirements
- Toxicity from previous cancer therapy returned to Grade 1 or less
- For premenopausal women with childbearing potential: negative pregnancy test within 7 days before treatment start, not lactating, and use adequate contraception during and for 6 months after treatment
You will not qualify if you...
- Prior treatment with ADC drugs containing topoisomerase I inhibitors
- Radiotherapy within 2 weeks before first dose
- Previous checkpoint inhibitor treatment before neoadjuvant/adjuvant chemotherapy
- Use of immunomodulatory drugs within 14 days before first dose
- History of severe cardiovascular or cerebrovascular disease within past 6 months
- Significant heart conduction issues or uncontrollable arrhythmia
- Active autoimmune or inflammatory diseases
- Long-term systemic corticosteroid use before first dose
- Other cancers that progressed or required treatment within 5 years
- Poorly controlled diabetes or hypertension, or related severe complications
- Grade 2 or higher radiation pneumonitis or current interstitial lung disease
- Severe respiratory impairment due to pulmonary disease
- Unstable thrombotic events within 6 months
- Active central nervous system metastases
- Massive, symptomatic, or poorly controlled effusions
- Allergies to humanized or chimeric antibodies or study drug components
- Prior organ or stem cell transplantation
- Positive for HIV, active tuberculosis, or active hepatitis B or C infections
- Serious infection within 4 weeks before first dose
- Participation in another clinical trial within 4 weeks before first dose
- Superior vena cava syndrome contraindicating rehydration
- History of substance abuse or severe neurological/psychiatric illness
- Tumor invading or wrapping major chest vessels
- Recent serious unhealed wounds, ulcers, or fractures
- Significant bleeding or bleeding tendency within 4 weeks
- Planned or recent live vaccine within 28 days before first dose
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive BL-B01D1 and PD-1 Monoclonal Antibody by intravenous infusion in 3-week cycles. The first cycle includes infusions on Day 1 and Day 8. Participants with clinical benefit may receive additional cycles until disease progression, intolerable toxicity, or other reasons for stopping treatment.
2 infusions per 3-week cycle for the first cycle; subsequent cycles as determined by clinical benefit
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
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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