A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
NCT Number: NCT06461156
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Locally Advanced or Metastatic NSCLC
Interventions: DRUG: HS-10504
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 230
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2027-03-31

Summary:
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.

Primary Outcome Measures: 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, From the single dose to the last dose of the first cycle defined as 21 days of multiple dosing (21 days).
Secondary Outcome Measures: 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., From the first dose until 28 days after the last dose|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, From the first dose until Circle 2 Day 1|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, From the first dose until Circle 2 Day 1|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, From the first dose until Circle 2 Day 1|Area under the curve (AUC) of HS-10504 (and its major matabolite) for the first dose and multiple dose adminitration of HS-10504, The AUC is defined as the area under the plasma concentration-time curve, From the first dose until Circle 2 Day 1|Trough plasma concentration (Ctrough) of HS-10504 (and its major matabolite), Ctrough is the observed plasma concentration immediately prior to the next dose administration, From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months|Objective response rate (ORR), ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, up to 24 months|Disease Control Rate (DCR), Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD), up to 24 months|Duration of response (DOR), Duration of response (DoR) determined by investigators according to RECIST 1.1. DoR was defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used, up to 24 months|Progression-free survival (PFS), Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival. Progression-free survival was deﬁned as the time from date of ﬁrst dose until the documentation of objective PD or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy., From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months|Overall survival (OS), only for dose-expansion stage subjects, OS was defined as the time from the first dose or random assignment (if any) to death from any cause, From the first dose up to death or withdrawal from study, whichever came first, assessed up to 24 months