A Phase I/II Study of WJ13404 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer
Status:
Recruiting
Trial end date:
2026-09-01
Target enrollment:
Participant gender:
Summary
This is an open-label phase I/II preliminary study, including dose escalation, dose
expansion, and efficacy expansion, to evaluate drug safety, tolerability, PK, and efficacy.
The dose escalation study evaluates the IMP's safety, tolerability, and PK in patients with
locally advanced or metastatic NSCLC who have experienced disease progression after
third-generation EGFR-TKI therapy. The dose expansion study, after 2-3 dose levels are
selected based on dose escalation results, further investigates the IMP's safety,
tolerability, and PK, explores preliminary efficacy, and determines RP2D in patients with
locally advanced or metastatic NSCLC harboring EGFR C797X mutation. The efficacy expansion
study evaluates the IMP's safety and efficacy in patients with locally advanced or metastatic
NSCLC harboring EGFR C797X mutation.