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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05662670
Other study ID # JS113-001-I
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 11, 2022
Est. completion date September 1, 2026

Study information

Verified date October 2022
Source Suzhou Junjing BioSciences Co., Ltd.
Contact Yongdong Zhang
Phone +86 18042483763
Email yongdong_zhang@junshipharma.com
Is FDA regulated No
Health authority
Study type Interventional

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.


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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Shanghai Pulmonary Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Suzhou Junjing BioSciences Co., Ltd. Sponsor GmbH

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary adverse events(AE) and serious adverse events(SAE) To evaluate incidence,severity and outcome of adverse events(AE),and serious adverse events(SAE) up to 3 years
Primary ORR 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 up to 3 years
Primary DLT 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 up to 2 years (only for dose escalation and dose expansion)
Secondary Cmax It's suitable for dose escaltion and does extension ,maximum plasmaconcentration up to 3 years
Secondary Tmax It's suitable for dose escaltion and does extension,time to Cmax up to 3 years
Secondary AUC 0-t It's suitable for dose escaltion and does extension,area under the concentration versus time curve from time 0 to the last measurable concentration. up to 3 years
Secondary t1/2 It's suitable for dose escaltion and does extension, elimination half-life. up to 3 years
Secondary CL/F It's suitable for dose escaltion and does extension, clearance. up to 3 years
Secondary Vd/F It's suitable for dose escaltion and does extensionapparent volume of distribution up to 3 years
Secondary ?z It's suitable for dose escaltion and does extension, elimination rate constant. up to 3 years
Secondary Css-min It's suitable for dose escaltion and does extension,minimum concentration at steady state. up to 3 years
Secondary Css-max It's suitable for dose escaltion and does extension,maximum concentration at steady state. up to 3 years
Secondary Css-ave It's suitable for dose escaltion and does extension, average concentration at steady state. up to 3 years
Secondary AUCtau-ss It's suitable for dose escaltion and does extension,area under the concentration versus time curve for a dosing interval at steady state. up to 3 years
Secondary Vss It's suitable for dose escaltion and does extension,volume of distribution at steady state. up to 3 years
Secondary AR It's suitable for dose escaltion and does extension,accumulation ratio. up to 3 years
Secondary DF It's suitable for dose escaltion and does extension,degree of fluctuation. up to 3 years
Secondary ORR It's suitable for dose escaltion and does extension, objective response rate. up to 3 years
Secondary DOR It's suitable for dose escaltion and does extension, duration of response. up to 3 years
Secondary DCR It's suitable for dose escaltion and does extension, disease control rate. up to 3 years
Secondary PFS It's suitable for dose escaltion and does extension, progression-free survival. up to 3 years
Secondary OS It's suitable for dose escaltion and does extension,overall survival. up to 3 years
Secondary adverse events(AE) and serious adverse events(SAE) To evaluate incidence,severity and outcome of adverse events(AE),and serious adverse events(SAE) up to 1 years(only for efficacy expansion stage)
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