NCT06986785 A Study of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 74 participants in total. It began in 2025-06-24 with a primary completion date of 2027-05.

Brief Summary

This study is a clinical study to explore the efficacy and safety of BL-B01D1 monotherapy, BL-B01D1 in combination with lenvatinib, BL-B01D1 in combination with PD-1 monoclonal antibody, and BL-B01D1 in combination with PD-1 monoclonal antibody and bevacizumab 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.

Contact & Investigator

Frequently Asked Questions

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.