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RECRUITING
NCT07253142
PHASE2

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

Sponsor: Shanghai Henlius Biotech

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-02-05

Completion Date

2028-06-19

Last Updated

2026-07-21

Healthy Volunteers

No

Interventions

DRUG

HLX43 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.

DRUG

HLX43 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.

Locations (10)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Fujian Cancer Hospital

Fu'zhou, Fujian, China

Cancer Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The People's Hospital of Guangxi Zhuangzu Autonomous Region

Nanning, Guangxi, China

Cangzhou People's Hospital

Cangzhou, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Hubei Cancer Hospital

Wuha, Hubei, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

THE Affiliated Hospital of Xuzhou Medical University

Xuzhou, China