This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-10504 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
RP2D for Combination
To evaluate the potent and tolerated of combination(s) and dosage(s) of HS-10504 based therapy in subjects with EGFR mutation-positive locally advanced or metastatic NSCLC who have experienced disease progression on or after prior treatment, which suitable for a Phase II trial
Time frame: Through the full duration of this trial, approximately 2 years
ORR
Investigator evaluated overall response rate, to evaluate the efficacy of each combination
Time frame: Through the full duration of this trial, approximately 2 years
TEAE
incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0
Time frame: Through the full duration of this trial, approximately 2 years
TRAE
incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0
Time frame: Through the full duration of this trial, approximately 2 years
SAE
incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0
Time frame: Through the full duration of this trial, approximately 2 years
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HS-20117 administered intravenously
SHR-1826 administered intravenously
SHR-A2102 administered intravenously