BL-B01D1 plus lenvatinib for advanced hepatocellular carcinoma

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma

This trial tests whether adding BL-B01D1 to lenvatinib helps people with advanced hepatocellular carcinoma shrink tumors or slow disease progression.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, lenvatinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06986785 on ClinicalTrials.gov

What this trial studies

This is a phase 2 interventional trial combining the experimental agent BL-B01D1 with the approved kinase inhibitor lenvatinib in adults with advanced hepatocellular carcinoma. Eligible participants are 18–75 years old with histologically or cytologically confirmed advanced HCC, at least one measurable lesion by RECIST v1.1, ECOG 0–1, and adequate organ and coagulation function; archived or fresh tumor tissue must be provided. The study will monitor tumor response and safety outcomes to characterize activity and tolerability of the combination. Treatment effects will be measured by standard radiographic response criteria and adverse event grading per NCI-CTCAE.

Who should consider this trial

Good fit: Adults aged 18–75 with advanced HCC, measurable disease, ECOG performance status 0–1, Child-Pugh A liver function, adequate organ/coagulation parameters, and willingness to provide tumor tissue would be ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), significant cirrhosis (Child-Pugh B/C), severe cardiac dysfunction, major organ failure, or life expectancy under three months are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could improve tumor control or delay progression compared with current single-agent approaches.

How similar studies have performed: Lenvatinib has been combined with other experimental agents in prior trials with some encouraging tumor control signals, but BL-B01D1 appears to be a novel agent without published clinical results in HCC to date.

Eligibility criteria

Inclusion Criteria:

1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Gender is not limited;
3. Age ≥18 years old and ≤75 years old;
4. Expected survival time ≥3 months;
5. Patients with advanced HCC confirmed by histology or cytology;
6. Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. ECOG score was 0-1;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. Organ function level must meet the requirements;
12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
13. Urinary protein ≤2+ or ≤1000mg/24h;
14. No cirrhosis or only Child-Pugh A cirrhosis;
15. If hepatitis B virus infection is negative or positive, the status of HBV surface antigen (HBsAg) should be confirmed by HBV serological test;
16. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Exclusion Criteria:

1. Patients with active central nervous system metastases;
2. Who had participated in any other clinical trial within 4 weeks before the trial dose;
3. Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;
4. Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;
5. Systemic corticosteroids or immunosuppressive therapy is required within 2 weeks before study dosing;
6. Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD/pulmonary inflammation requiring steroid treatment;
7. Serious systemic infection within 4 weeks before screening;
8. Patients at risk for active autoimmune disease or with a history of autoimmune disease;
9. Other malignant tumors within 5 years before the first treatment;
10. Human immunodeficiency virus antibody positive, active tuberculosis or hepatitis C virus infection;
11. Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;
12. Diabetic patients with poor glycemic control;
13. Had a history of severe cardiovascular and cerebrovascular diseases;
14. Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;
15. Subjects with clinically significant bleeding or significant bleeding tendency within the previous 4 weeks were screened;
16. Patients with massive or symptomatic effusions or poorly controlled effusions;
17. Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart;
18. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
19. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
20. Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug;
21. The cumulative dose of anthracyclines \> 360 mg/m2 in previous (new) adjuvant therapy;
22. Pregnant or lactating women;
23. Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
24. Other conditions for trial participation were not considered appropriate by the investigator.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Advanced Hepatocellular Carcinoma