Actively Recruiting
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-08-20
46
Participants Needed
1
Research Sites
30 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
Researchers are evaluating the efficacy and safety of a combination treatment using BL-B01D1 and lenvatinib in adult patients with advanced hepatocellular carcinoma, a type of liver cancer. This phase II clinical study is designed to understand how well this treatment works and how safe it is for patients with this condition. The trial is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. and focuses on patients who have measurable tumors and meet specific health criteria. Participants will first receive BL-B01D1 by intravenous infusion in a 3-week cycle. In the same initial cycle, they will also receive lenvatinib orally once daily, with the dose based on body weight (8 mg if under 60 kg or 12 mg if 60 kg or above). Those who benefit from the treatment may continue receiving additional cycles until disease progression, intolerable side effects, or other reasons lead to stopping the treatment. During the study, participants will be regularly assessed for tumor response, including measurements of tumor size and control, progression-free survival, and duration of response, over a period of up to about 24 months. Safety monitoring includes tracking any treatment-related adverse events. The study requires participants to provide tumor tissue samples and undergo routine evaluations such as physical exams, laboratory tests, and imaging to monitor their condition and response to treatment throughout the trial duration.
CONDITIONS
Brief Title
A Study of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreement to follow study protocols
- Any gender
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Confirmed advanced hepatocellular carcinoma by histology or cytology
- Willingness to provide archived or fresh tumor tissue samples
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status 0 or 1
- Previous antineoplastic therapy toxicity resolved to grade 1 or less
- No severe cardiac dysfunction; left ventricular ejection fraction ≥50%
- Adequate organ function
- Coagulation function within specified limits (INR ≤1.5×ULN, APTT ≤1.5×ULN)
- Urinary protein ≤2+ or ≤1000mg/24h
- No cirrhosis or only Child-Pugh A cirrhosis
- Confirmed hepatitis B surface antigen status
- Negative pregnancy test for premenopausal women; adequate contraception during and 6 months after treatment
You will not qualify if you...
- Active central nervous system metastases
- Participation in another clinical trial within 4 weeks prior to dosing
- Anti-tumor therapy (chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first study drug use
- Major surgery within 4 weeks before first dose
- Use of systemic corticosteroids or immunosuppressive therapy within 2 weeks before dosing
- Pulmonary disease grade 3 or higher or history of interstitial lung disease requiring steroids
- Serious systemic infection within 4 weeks before screening
- Active or history of autoimmune diseases
- Other cancers within 5 years before first treatment
- HIV antibody positive, active tuberculosis, or hepatitis C infection
- Poorly controlled hypertension despite two antihypertensive drugs
- Poorly controlled diabetes
- History of severe cardiovascular or cerebrovascular disease
- Previous stem cell, bone marrow, or organ transplantation
- Significant bleeding or bleeding tendency in prior 4 weeks
- Massive or symptomatic effusions or poorly controlled effusions
- Tumor invasion of major arteries or heart structures
- Unstable thrombotic events within 6 months before screening
- Prior treatment with ADC drugs with topoisomerase I inhibitor toxin
- Allergy to recombinant humanized antibodies or study drug excipients
- Cumulative anthracycline dose over 360 mg/m2 in prior therapy
- Pregnant or lactating women
- History of psychotropic drug abuse or mental disorders affecting participation
- Other investigator-determined conditions making participation inappropriate
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 by intravenous infusion combined with daily oral Lenvatinib. The first treatment cycle lasts 3 weeks. Participants with clinical benefit may receive additional treatment cycles until disease progression or intolerable toxicity occurs.
Visits occur throughout each treatment cycle as needed for administration and monitoring
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
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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