RecruitingPhase 2NCT06769113

A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent/Metastatic Esophageal Squamous Cell Carcinoma (ESCC) Failed or Intolerance to Standard First-line Therapy


Sponsor

Shanghai Henlius Biotech

Enrollment

72 participants

Start Date

Jan 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent/Metastatic Esophageal Squamous Cell Carcinomar (ESCC) Failed or Intolerance to Standard First-Line Therapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing HLX43 — a new antibody-drug conjugate (a drug that delivers chemotherapy directly to cancer cells via an antibody) that targets PD-L1 — in patients with advanced esophageal squamous cell carcinoma (ESCC) whose cancer has progressed after standard treatment. **You may be eligible if...** - You have been diagnosed with esophageal squamous cell carcinoma confirmed by biopsy or pathology - Your cancer is advanced and has failed or you could not tolerate prior first-line treatment (including platinum-based chemo and immunotherapy if your tumor is PD-L1 positive) - You are between 18 and 75 years old - Your general health is adequate to handle this treatment **You may NOT be eligible if...** - You have already received too many prior lines of treatment beyond the study criteria - Your overall health or organ function is too poor - You have uncontrolled brain metastases or active autoimmune conditions - You have had severe prior reactions to similar types of antibody-drug therapy 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

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

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

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)

Shandong Cancer Hospital

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

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NCT06769113


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