RecruitingPhase 1NCT06461156

A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10504 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

230 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new targeted therapy drug called HS-10504 in people with advanced or spreading non-small cell lung cancer (NSCLC) whose tumors carry an EGFR mutation and whose cancer has progressed after previous EGFR-targeted treatment. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic NSCLC - Your tumor has an EGFR mutation confirmed by testing - Your cancer has progressed on or after previous EGFR-targeted therapy (EGFR-TKIs) - You have at least one measurable tumor on scans - You are in good health with a life expectancy over 12 weeks **You may NOT be eligible if...** - Your cancer has other known driver mutations besides EGFR - You have had a fourth-generation EGFR inhibitor previously - You have had chemotherapy or other anti-cancer drugs within 14 days of starting the study - You have received recent radiation therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHS-10504

HS-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.


Locations(1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

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NCT06461156