The aim of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and immunogenicity of ES102 in combination with Toripalimab in subjects with advanced non-small cell lung cancer (NSCLC).
Having sufficient understanding of this study and being willing to sign the informed consent form (ICF).
Males or females, age 18-75 years at the time of signing the informed consent form.
Histologically or cytologically confirmed, unresectable locally advanced and metastatic non-small cell lung cancer not suitable for radical concurrent chemoradiotherapy.
Without known EGFR mutation/ALK fusion/ROS1 fusion gene.
Any prior therapy targeting OX40.
Receipt of any other investigational drug or device intervention within 28 days prior to the first dose of the study drug.
Receipt of anticancer Chinese herbal therapy within 14 days prior to the first dose of the study drug.
Receipt of radiotherapy within 14 days prior to the first dose of the study drug.
Single group
ES102
DrugES102 is administered via intravenous infusion, once every 21 days.
Toripalimab
DrugToripalimab is administered via intravenous infusion, once every 21 days.
Objective Response Rate (ORR) assessed by IRC
Proportion of subjects achieving complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Independent Review Committee (IRC).
ORR assessed by investigators
Proportion of subjects achieving CR or PR according to RECIST v1.1 as assessed by investigators.
Disease control rate (DCR)
Proportion of subjects achieving CR, PR or stable disease (SD) according to RECIST v1.1 as assessed by IRC and investigators.
Duration of response (DOR)
The time from first documented evidence of CR or PR to disease progression or death, whichever occurs first, in subjects who demonstrate a CR or PR per RECIST v1.1 , as assessed by IRC and investigators.
Progression-free survival (PFS)
Time from the date of first study drug administration to disease progression or death, whichever occurs first, as assessed by IRC and investigators.
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