Actively Recruiting
A Study 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
127 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 a clinical study to explore the efficacy and safety of BL-B01D1 combined with lenvatinib in patients with advanced hepatocellular carcinoma.
CONDITIONS
Official 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 willing to follow study requirements
- Any gender
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Confirmed advanced hepatocellular carcinoma by histology or cytology
- Agreed to provide tumor tissue samples
- At least one measurable tumor lesion per RECIST v1.1
- ECOG performance status of 0 or 1
- Toxicity from prior cancer therapy resolved to grade 1 or less
- No severe heart dysfunction with left ventricular ejection fraction above 50%
- Adequate organ function
- Coagulation function within specified limits (INR ≤1.5×ULN, APTT ≤1.5×ULN)
- Urinary protein ≤2+ or ≤1000 mg/24h
- No cirrhosis or only Child-Pugh A cirrhosis
- Hepatitis B status confirmed by serology
- For premenopausal women, negative pregnancy test within 7 days before treatment and not breastfeeding
- Use of effective contraception during and for 6 months after treatment
You will not qualify if you...
- Active central nervous system metastases
- Participation in another clinical trial within 4 weeks before dosing
- Anti-tumor therapy (chemotherapy, radiotherapy, biologic) within 4 weeks prior to study drug
- Major surgery within 4 weeks before first dose
- Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks before dosing
- Severe lung disease (grade 3 or higher) or history of ILD requiring steroid treatment
- Serious systemic infection within 4 weeks before screening
- Active or history of autoimmune disease
- Other cancers within 5 years before treatment
- HIV positive, active tuberculosis, or hepatitis C infection
- Poorly controlled hypertension despite two antihypertensive drugs
- Poorly controlled diabetes
- History of severe cardiovascular or cerebrovascular disease
- Prior stem cell, bone marrow, or organ transplant
- Significant bleeding or bleeding tendency in the past 4 weeks
- Large or symptomatic fluid buildup not controlled
- Tumor invasion of major arteries or heart structures
- Unstable blood clots requiring treatment within 6 months
- Prior treatment with antibody drug conjugates containing topoisomerase I inhibitor
- Allergy to humanized antibodies or study drug components
- Prior anthracycline exposure exceeding 360 mg/m2
- Pregnant or breastfeeding women
- History of drug abuse or uncontrolled psychiatric disorders
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here