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

NCT05662670 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Locally Advanced or Metastatic NSCLC

Interventions

DRUG

WJ13404 tablets

Dose escalation: 6 dose levels The dose escalation study is proposed to include 6 dose levels: 30, 90, 180, 270, 360, and 480 mg once daily. (It can be adjusted based on clinical PK data and safety results after discussion between PI and the sponsor). Dose-expansion: After the initial data evaluation, the Sponsor and the SMC will select 2-3 dose levels to evaluate drug safety and PK further, explore its preliminary efficacy, and determine RP2D. Efficacy expansion: The RP2D determined in dose escalation and dose expansion will be applied.

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Suzhou Junjing BioSciences Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2023-10-01
Completion
2024-04-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05662670 on ClinicalTrials.gov