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)

Conditions

Advanced non-small cell lung cancer (NSCLC)

Brief summary

Objective response rate (ORR) (assessed by the Blinded Independent Central Review [BICR] as per RECIST v1.1)

Detailed description

Overall survival (OS), Duration of response (DOR) and disease control rate (DCR) (assessed by the BICR and the investigator), Adverse events (AEs), serious adverse events (SAEs), laboratory tests, vital signs, 12-lead ECG, and physical examination, Blood drug concentration and pharmacokinetics parameters of HLX43 at different doses (ADC, total antibody, and free small molecule toxin), Positive rates of anti-HLX43 antibody (ADA) and neutralizing antibody (NAb), Potential predictive or drug resistance biomarkers, such as PD-L1 expression levels, tumor-related gene mutations or expression levels, serum proteomic profiles, Quality of life assessment, Objective response rate (ORR) (assessed by investigator as per RECIST v1.1), Progression-free survival (PFS) (assessed by the BICR and the investigator as per RECIST v1.1)

Related papers

No related papers found yet.

Interventions

DRUGHLX43 for Injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) (assessed by the Blinded Independent Central Review [BICR] as per RECIST v1.1)	—

Secondary

Measure	Time frame
Overall survival (OS), Duration of response (DOR) and disease control rate (DCR) (assessed by the BICR and the investigator), Adverse events (AEs), serious adverse events (SAEs), laboratory tests, vital signs, 12-lead ECG, and physical examination, Blood drug concentration and pharmacokinetics parameters of HLX43 at different doses (ADC, total antibody, and free small molecule toxin), Positive rates of anti-HLX43 antibody (ADA) and neutralizing antibody (NAb), Potential predictive or drug resistance biomarkers, such as PD-L1 expression levels, tumor-related gene mutations or expression levels, serum proteomic profiles, Quality of life assessment, Objective response rate (ORR) (assessed by investigator as per RECIST v1.1), Progression-free survival (PFS) (assessed by the BICR and the investigator as per RECIST v1.1)	—

Measure

Time frame

Overall survival (OS), Duration of response (DOR) and disease control rate (DCR) (assessed by the BICR and the investigator), Adverse events (AEs), serious adverse events (SAEs), laboratory tests, vital signs, 12-lead ECG, and physical examination, Blood drug concentration and pharmacokinetics parameters of HLX43 at different doses (ADC, total antibody, and free small molecule toxin), Positive rates of anti-HLX43 antibody (ADA) and neutralizing antibody (NAb), Potential predictive or drug resistance biomarkers, such as PD-L1 expression levels, tumor-related gene mutations or expression levels, serum proteomic profiles, Quality of life assessment, Objective response rate (ORR) (assessed by investigator as per RECIST v1.1), Progression-free survival (PFS) (assessed by the BICR and the investigator as per RECIST v1.1)

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Outcome results

None listed