A Study of WX390 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are: PFS, OS, DoR at week 48; antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.

Detailed Description
-----------------
This study will be an open-label, multicenter phase II clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. And then patents will be administered for 12 cycles treatment and 30 days safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.

Official Title
-----------------
An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: WX390


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Histological or cytological confirmed advanced solid tumor, standard regimen failed Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Life expectancy of more than 3 months At least one measurable lesion according to RECIST 1.1 Adequate organ function Signed and dated informed consent Exclusion Criteria: Anti-cancer therapy within 30 days prior to the initiation of investigational treatment Major surgery within 30 days prior to the initiation of study treatment Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia) Patients who are suffering active interstitial lung disease Evidence of ongoing or active serious infection Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment Active hepatitis B or C infection Inability to take medication orally Abuse of alcohol or drugs Pregnant or lactating women People with cognitive and psychological abnormality or with low compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WX390<br>Participants will receive WX390 continuous oral dosing (1.1 mg once a day). | Drug: WX390<br>* WX390 tablet, 1.1 mg once a day<br>* Other names: WXFL10030390;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS, time from the first dose of trial medication to the first occurrence of disease progression or death due to any cause on study, whichever occurs first. | Week 48 | 
| Overall Survival (OS) | OS, time from first dose of trial medication to death due to any cause. | Week 48 | 
| Duration of Response (DOR) | DoR, the time from the first occurrence of objective response until disease progression or death from any cause, whichever occurs first. | Week 48 | 
| Progression-free survival rate (PFSR) | PFSR, Percentage of patients alive without progression from baseline. | Week 24 and Week 48 | 
| Objective Response Rate (ORR) | ORR, proportion of patients with complete response (CR) or partial response (PR). | Week 24 and Week 48 | 
| Disease control rate (DCR) | DCR, proportion of patients with CR or PR or SD. | Week 24 and Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, nature, and severity of adverse events (AEs) | Incidence, nature, and severity of adverse events (AEs) refer to the frequency, type, and level of harm of undesirable effects in clinical trials. Incidence shows how often AEs occur. Nature describes the specific characteristics of AEs, while severity indicates the extent of harm caused. | Week 24 and Week 48 |