CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 243 target
Drug / intervention
HLX43 DOSE 1 (2.0 mg/kg) +1 moredrug
Likely dose
HLX43 DOSE 1 (2.0 mg/kg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06907615
NCT06907615Phase 2RecruitingOn TrackUpdated 10mo ago
CompareCT.gov

An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

Shanghai Henlius Biotech·interventional·Posted Apr 2, 2025·Updated Aug 17, 2025

In Brief

A Phase 2 clinical trial evaluating HLX43 DOSE 1 (2.0 mg/kg) and HLX43 DOSE 2 (2.5 mg/kg) for Non Small Cell Lung Cancer. Currently recruiting, targeting 243 participants across 2 sites in 2 countries.

Detailed 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 Advanced Non-small Cell Lung Cancer (NSCLC)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer
CountriesChina, United States
CollaboratorsHenlius USA Inc.

Timeline

Phase 2Recruiting
202620272028
First PostedApr 2, 2025
Enrollment StartJun 9, 2025
Primary CompletionApr 20, 2028
Study CompletionJun 4, 2028
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 1.2 years agoPrimary completion in 1.8 years

Interventions

HLX43 DOSE 1 (2.0 mg/kg)drug

Dose 1; 2.0 mg/kg; 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.

HLX43 DOSE 2 (2.5 mg/kg)drug

Dose 2; 2.5 mg/kg; 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.