RecruitingPhase 2NCT06986785

A Study of BL-B01D1 Combined With Lenvatinib in Patients With 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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

46 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new drug combination — BL-B01D1 (an antibody-drug conjugate) combined with lenvatinib (a targeted therapy) — is safe and effective for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that has spread or cannot be surgically removed. **You may be eligible if...** - You are 18–75 years old - You have advanced liver cancer confirmed by tissue biopsy or imaging - You have at least one measurable tumor - Your ECOG performance score is 0 or 1 (meaning you are generally functional and active) - Your heart, liver, kidney, and blood counts meet the study's minimum requirements - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have severe heart problems or a heart ejection fraction below 50% - You have unresolved serious side effects from prior cancer treatments - You are outside the 18–75 age range - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGLenvatinib

8mg (body weight \< 60kg), or 12mg (body weight ≥60kg), QD.


Locations(1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

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NCT06986785


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