A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSC
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.
| Condition(s) | Locally Advanced or Metastatic NSCLC |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 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. * At least 1 target lesion according to RECIST 1.1. * ECOG PS score: 0-1. * Estimated life expectancy\> 12 weeks. * Men or women should be using adequate contraceptive measures throughout the study. * Women must have the evidence of non-childbearing potential. * Signed and dated Informed Consent Form. Exclusion Criteria: * Subjects with known oncogenic driver genes other than EGFR. * Subjects with mixed cell histologic or with phenotypic transform |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Locations | Guangzhou, China |
| Start date | 2025-07-22 |
| NCT ID | NCT06461156 |
| Official listing | https://clinicaltrials.gov/study/NCT06461156 |