RecruitingPhase 1Phase 2NCT05435248

Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10375 Monotherapy in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

354 participants

Start Date

Mar 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

HS-10375 is an oral, highly selective, small molecular inhibitor of EGFR C797S. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10375 in Chinese advanced or metastatic NSCLC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called HS-10375 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that carries a specific genetic change (EGFR C797S mutation). This mutation often develops after treatment with earlier targeted therapies and can make those treatments stop working. **You may be eligible if:** - You are 18 or older - You have locally advanced or metastatic NSCLC that has stopped responding to prior treatments - You are in generally good physical condition (ECOG score 0–1) - You have at least one measurable tumor on scans - Your life expectancy is at least 12 weeks **You may NOT be eligible if:** - Your cancer does not have the specific EGFR mutation tested in this study - Your overall health or organ function falls below required thresholds - You are pregnant or breastfeeding 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-10375

HS-10375 will be administered orally once daily in a continuous regimen


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT05435248