HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.
Males or females, aged ≥ 18 years.
Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC
Progressive disease on or after prior treatment with EGFR-TKIs.
Enrollment will be restricted to participants with evidence of EGFR-positive in tumor as determined by local or central testing.
Subjects with known oncogenic driver genes other than EGFR.
Subjects with mixed cell histologic or with phenotypic transformation.
Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors.
Cytotoxic chemotherapy, any other investigational drugs, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study.
Single group
HS-10504
DrugHS-10504 will be administered orally once daily in a continuous regimen. Participants will continue treatment until experiencing objective disease progression or meeting other protocol-specified criteria for discontinuation of study treatment.
the maximum tolerated dose (MTD) or the maximum applicable dose (MAD)
To determine the MTD or MAD for further evaluation of oral administration of HS-10504 in subjects with NSCLC
Incidence and severity of adverse events (AEs).
Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0.
maximum plasma concentration (Cmax) of HS-10504 (and its major matabolite) for the first dose and multiple dose adminitration of HS-10504
Cmax is the maximum observed concentration
Time to reach maximum plasma concentration (Tmax) for the first dose and multiple adminitration of HS-10504 (and its major matabolite)
Tmax is defined as time to reach maximum observed plasma concentration
half-life (T1/2) of HS-10504 (and its major matabolite) for the first dose and multiple dose adminitration of HS-10504
half-life is the time measured for the concentration to decrease by one half
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