Actively Recruiting
A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-18
21
Participants Needed
1
Research Sites
96 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 study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-B16D1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumor.
CONDITIONS
Official Title
A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreement to follow the study protocol
- Any gender
- Age 18 to 75 years for Phase Ia; 18 years and older for Phase Ib
- Expected survival time of at least 3 months
- Histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer or other solid tumors with failed or no standard treatment options
- Consent to provide archival or fresh tumor tissue samples within 3 years
- At least one measurable extracranial lesion as per RECIST v1.1
- ECOG performance status of 0 or 1
- Toxicity from previous cancer treatments returned to grade 1 or less as per NCI-CTCAE v5.0
- No severe cardiac dysfunction, with left ventricular ejection fraction at least 50%
- Adequate organ function without recent blood transfusion or hematopoietic stimulation factor therapy within 14 days before first dose
- Coagulation function within specified limits (INR ≤1.5, aPTT ≤1.5 ULN)
- Urinary protein levels ≤2+ or ≤1000mg/24h
- Premenopausal women with childbearing potential must have a negative pregnancy test within 7 days before treatment and must not be breastfeeding
- All patients must use effective contraception during treatment and for 6 months after completing treatment
You will not qualify if you...
- Use of chemotherapy, biological therapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks; oral fluorouracil
- History of severe heart disease
- Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Other current or past malignant tumors
- Unstable thrombotic events requiring treatment within 6 months
- Poorly controlled hypertension despite two antihypertensive drugs (systolic >150 mmHg or diastolic >100 mmHg)
- Poor glycemic control
- Grade 1 or higher radiation pneumonitis or current/suspected interstitial lung disease
- Severe respiratory impairment from pulmonary diseases
- Primary CNS tumors or CNS metastases not controlled by local treatment
- Allergy to recombinant humanized or human-mouse chimeric antibodies or any BL-B16D1 components
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation
- Excessive cumulative doses of anthracyclines in previous treatments
- Positive for HIV antibody, active tuberculosis, or active hepatitis B or C infection
- Serious infection within 4 weeks or signs of pulmonary infection within 2 weeks before first dose
- Massive or symptomatic effusions or poorly controlled effusions
- Participation in another clinical trial within 4 weeks before first dose
- Certain eye diseases including active infections, corneal ulcers, monocular vision, history of corneal transplant, contact lens dependence, uncontrolled glaucoma, or progressive retinopathy
- Other conditions considered unsuitable by the investigator for 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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