RecruitingPhase 2NCT06742892

A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy

A Phase II Clinical Study to Evaluate HLX43 (Anti-PD-L1 ADC) in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy


Sponsor

Shanghai Henlius Biotech

Enrollment

90 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study tests a new drug called HLX43 for people with advanced liver cancer (hepatocellular carcinoma) whose cancer has progressed or who could not tolerate standard therapies like immunotherapy combinations or drugs such as lenvatinib or sorafenib. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed liver cancer (HCC) that has progressed or could not be tolerated on at least one standard treatment - Your liver function is rated Child-Pugh A - Your ECOG performance status is 0 or 1 - Your expected survival is at least 3 months - Your organ function is adequate **You may NOT be eligible if...** - You have bile duct cancer, mixed-type liver cancer, or fibrolamellar carcinoma - You have had a liver transplant or are being considered for one - You had serious bleeding from the stomach or esophagus within the past 6 months - You have cancer spread to the brain or spine - You have had a heart attack or stroke in the past 6 months - You are pregnant or breastfeeding - You have active HIV or untreated hepatitis 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

DRUGHLX43 DOSE 1

Dose 1; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

DRUGHLX43 DOSE 2

Dose 2; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

DRUGHLX43 DOSE 3

Dose 3; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.


Locations(1)

Hunan Cancer Hospital

Hunan, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT06742892


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