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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HS-10504 | Unknown | 400 mg | — |
| Subject | Midazolam | Small molecule | 1 mg | Oral |