Clinical trial NCT06986785: A Study of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
First posted: 2025-05-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with lenvatinib in patients with advanced hepatocellular carcinoma.


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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 24 months
measure: Recommended Phase II Dose (RP2D)
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 24 months
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 24 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 24 months
measure: Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
References: