Actively Recruiting
A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
36
Participants Needed
2
Research Sites
276 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
S
SystImmune Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this study, the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase II dose (RP2D), the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 will be investigated in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors.
CONDITIONS
Official Title
A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and comply with the protocol requirements
- No gender restrictions
- Age 18 years to 75 years
- Expected survival time of at least 3 months
- Histologically and/or cytologically confirmed unresectable locally advanced or metastatic breast cancer and other solid tumors with failed standard treatment, intolerance to standard treatment, no current standard treatment available, or inability to access standard treatment
- No prior systemic therapy for unresectable locally advanced or recurrent/metastatic triple-negative breast cancer
- Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 3 years
- Must have at least one measurable lesion as defined by RECIST v1.1
- ECOG performance status score of 0 or 1
- Toxicity from prior anti-tumor therapy recovered to Grade 1 or less as defined by NCI-CTCAE v5.0
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) 50% or higher
- Organ function levels meet the requirements without transfusion or use of any cell growth factors and/or platelet-raising drugs within 14 days before the first dose
- Coagulation function: International Normalized Ratio (INR) 1.5 or less, and activated partial thromboplastin time (APTT) 1.5 times upper limit of normal or less
- Urine protein 2+ or less or 1000 mg/24h or less
- For premenopausal women with childbearing potential, a negative pregnancy test within 7 days before starting treatment and not breastfeeding
- All patients must use adequate barrier contraception throughout treatment and for 6 months after treatment ends
You will not qualify if you...
- Received biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs such as tegafur/gimeracil/oteracil (S-1) or capecitabine, or oral endocrine therapy, or palliative radiotherapy within 2 weeks before the first dose)
- History of severe heart disease
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia
- Active autoimmune or inflammatory diseases
- Diagnosis of other malignancies within 2 years prior to the first dose
- Poorly controlled hypertension despite use of two antihypertensive medications
- Poorly controlled blood glucose or concurrent diabetic gangrene
- History or suspicion of interstitial lung disease (ILD)
- Pulmonary disease causing significant respiratory impairment
- Unstable blood clots or thrombotic events within 6 months before screening
- Central nervous system metastases or carcinomatous meningitis
- Significant or poorly controlled serous cavity effusion
- History of hypersensitivity to recombinant humanized or human-mouse chimeric antibodies or excipients of BL-B01D1
- Tumor invasion or encasement of major blood vessels affecting eligibility
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation
- Cumulative anthracycline dose over 360 mg/m2 in prior therapy
- Positive for HIV antibody, active tuberculosis, active hepatitis B or C infection
- Severe infection within 4 weeks before the first dose; signs of active pulmonary infection within 2 weeks
- Participation in another clinical trial within 4 weeks before the first dose
- Any other condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
2
Fudan University ShangHai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
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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