Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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.

WJ13404 tablets

Yongdong Zhang

Banyu Zhang

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.

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

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

To evaluate incidence，severity and outcome of adverse events（AE),and serious adverse events（SAE)

Proportion of patients who have the best response of confirmed or partial response as per RECIST v1.1.ORR, along with its 95% CI, will be calculated

DLT is defined as any of the following toxicities that occur during the DLT observation and are deemed by investigators possibly, probably, or definitely related to WJ13404 as per NCI-CTCAE v5.0

It's suitable for dose escaltion and does extension ,maximum plasmaconcentration

It's suitable for dose escaltion and does extension,time to Cmax

It's suitable for dose escaltion and does extension,area under the concentration versus time curve from time 0 to the last measurable concentration.

It's suitable for dose escaltion and does extension, elimination half-life.

It's suitable for dose escaltion and does extension, clearance.

It's suitable for dose escaltion and does extensionapparent volume of distribution

It's suitable for dose escaltion and does extension, elimination rate constant.

It's suitable for dose escaltion and does extension,minimum concentration at steady state.

It's suitable for dose escaltion and does extension,maximum concentration at steady state.

It's suitable for dose escaltion and does extension, average concentration at steady state.

It's suitable for dose escaltion and does extension,area under the concentration versus time curve for a dosing interval at steady state.

It's suitable for dose escaltion and does extension,volume of distribution at steady state.

It's suitable for dose escaltion and does extension,accumulation ratio.

It's suitable for dose escaltion and does extension,degree of fluctuation.

It's suitable for dose escaltion and does extension, objective response rate.

It's suitable for dose escaltion and does extension, duration of response.

It's suitable for dose escaltion and does extension, disease control rate.

It's suitable for dose escaltion and does extension, progression-free survival.

It's suitable for dose escaltion and does extension,overall survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase I/II Study of WJ13404 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer	NCT05662670	Locally Advance...	WJ13404 tablets	18 Years -	Suzhou Junjing BioSciences Co., Ltd.
A Phase I/II Study of WJ13404 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer	NCT05662670	Locally Advance...	WJ13404 tablets	18 Years -	Suzhou Junjing BioSciences Co., Ltd.

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