Twice daily (except for single dose), 12 hours apart, fixed time is recommended

WJ05129:Twice daily (except for single dose), 12 hours apart, fixed time is recommended

WJ05129

Hongkai Wang

Yuan Wang

This study was an open, multicenter Phase I/II clinical study of WJ05129 in patients with locally advanced or metastatic malignant solid tumors in China, which was divided into three stages: dose escalation, dose extension and efficacy extension. The study included screening, treatment and follow-up periods. Dose escalation phase: adopt "3 + 3" dose escalation mode, preset 5 dose groups: 1.25mg, 2.5mg, 5mg, 7.5mg, 10mg, oral, twice a day (only once on the first day), planned to include a maximum of 30 subjects; Dose expansion phase: 2 dose groups will be planned in this phase, and the specific dose will be determined according to the trial data in the dose escalation phase. The maximum number of participants in each dose group will be 12. Efficacy expansion phase: It is preliminarily planned to expand three cohorts of Rb negative TNBC and SCLC and NB with high Myc expression, and recruit about 24 people in each cohort.

A Study of WJ05129 in Advanced Malignant Solid Tumors

A Phase I/II Clinical Study of WJ05129 Tablets in Patients With Locally Advanced or Metastatic Malignant Solid Tumors

It is suitable for dose escalation and dose extension.DLT is defined as any of the following toxic reactions that SMC considers to have occurred during the DLT observation period and may be causally related to WJ05129.

It is suitable for dose escalation and dose extension.Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in physical examination, ECOG score, vital signs, electrocardiogram, ophthalmic tests and laboratory tests.

It is suitable for dose escalation and dose extension.If the number of DLT patients is 0 and the next higher dose is unacceptable, the current dose is declared MTD.

It is suitable for dose escalation and dose extension.RP2D will be determined based on a combination of safety, tolerability, PK and/or pharmacodynamic studies .

It is suitable for the curative effect development stage.Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in physical examination, ECOG score, vital signs, electrocardiogram, ophthalmic tests and laboratory tests.

It is suitable for the curative effect development stage.Objective Response Rate by RECIST 1.1,IMWG,RANO,IWG and Lugano 2014.

It is suitable for dose escalation and dose extension.Maximum Plasma Concentration

It is suitable for dose escalation and dose extension.Time to Cmax

It is suitable for dose escalation and dose extension.Area under the concentration versus time curve from time 0 to the last measurable concentration

It is suitable for dose escalation and dose extension.AUC from time 0 to infinity

It is suitable for dose escalation and dose extension.Elimination half life time

It is suitable for dose escalation and dose extension.Clearance

It is suitable for dose escalation and dose extension.Apparent volume of distribution

It is suitable for dose escalation and dose extension.elimination rate constant

It is suitable for dose escalation and dose extension.Objective Response Rate by RECIST 1.1,IMWG,RANO,IWG and Lugano 2014.

It is suitable for the curative effect development stage

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of WJ05129 in Advanced Malignant Solid Tumors	NCT05326035	Locally Advance...	WJ05129	18 Years - 75 Years	Suzhou Junjing BioSciences Co., Ltd.
A Study of WJ05129 in Advanced Malignant Solid Tumors	NCT05326035	Locally Advance...	WJ05129	18 Years - 75 Years	Suzhou Junjing BioSciences Co., Ltd.

Spots Global Cancer Trial Database for wj05129

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Spots Global Cancer Trial Database for wj05129

Every month we try and update this database with for wj05129 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for wj05129 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.