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A Phase I/II Study of WJ13404 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer

Locally Advanced or Metastatic NSCLC Clinical Trial

Official title:
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WJ13405 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05662670
Study type Interventional
Source Suzhou Junjing BioSciences Co., Ltd.
Contact Yongdong Zhang
Phone +86 18042483763
Email yongdong_zhang@junshipharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date October 11, 2022
Completion date September 1, 2026
View Details
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