RecruitingPhase 2NCT07253142

A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Humanized Anti-PD-1 Monoclonal Antibody Injection) in Advanced Stage Lung Cancer

Sponsor

Shanghai Henlius Biotech

Enrollment

120 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Small Cell Lung Cancer

Summary

The study is to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced lung cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HLX43 dose 1 and a drug called HLX43 dose 2 for people with non-small cell lung cancer and small cell lung cancer. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 75 Years.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

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.