drugset / Trial / NCT07685041

An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer

NCT07685041

Phase 1 Not yet recruiting 24 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with EGFR-TKIs.

Timeline

Start
2026-06-27
Primary completion
2026-11-19
Completion
2027-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject HS-10504 Unknown 400 mg
Subject Midazolam Small molecule 1 mg Oral